Migraine Blog

Phase 3 Clinical Trial Next Generation Dihydroergotamine With Advanced Inhaler Delivery Offer Migrainuers More Choice

MAP Pharmaceuticals Embarks On Phase 3 Clinical Trial in Patients With Migraine Disease

WASHINGTON, DC; August 14th, 2008—Football season is here again, and with it so are the weekend rituals followed by those Monday morning quarterbacking sessions with our co-workers and friends. 

This made us realize while advocating for Migraine disease we have had the opportunity to meet some of the NFL’s greatest players!  Sometimes this opportunity happened when Michael John has as a Migraine Art Awareness Exhibit which we had the pleasure to meet NLF All-Pro Washington Redskins Darrell Green and John Riggins, both wearing their Super Bowl rings to boot!

But it is another NFL hero we met that comes to mind when Michael John saw several medical posters back in Boston earlier this summer at the American Headache Society 50th Annual Scientific Meeting.   Many years ago Michael John spent some time talking with the Denver Bronco’s All Star player Terrell Davis right after his MVP (most valuable player) award for his performance in Super Bowl XXXII.  Michael John was attending the AHS medical meeting in San Francisco back then and met Terrell at an AHS evening event.  The two talked about Migraines, Man-to-Man Coverage, and MAGNUM.  He has just signed a different kind of contract, one as a health advocate for Migraine awareness for a drug company called Novartis Pharmaceuticals Corporation, the makers of the drug that allowed him to get back in the game, the Super Bowl game that is—D.H.E. 45 also known as Dihydroergotamine.

“Davis shrugged off the onset of a migraine headache to accumulate 157 yards on 30 carries as the Broncos outrushed the Packers, 179-95, only the second time the AFC has outrushed the NFC in the last 14 years.”

By Paul Attner, The Sporting News
Originally printed in The Sporting News, Feburary 2, 1998”

Now for those of you who follow your sports as well as love sports trivia, and who couldn’t in the shadow of the 24/7 coverage of the China Olympics these days?  Well, have to tell you hundreds of sports writers just plain got part of the story of the Super Bowl XXXII’s MVP wrong!  The common sports page report of how “Denver Bronco’s Terrell Davis played with a horrible Migraine ‘headache’ to overcome and became the first player in Super Bowl history ever to score 3 rushing touchdowns.” Nope. Did not happen that way.  We should know, MAGNUM fielded dozens of calls during Super Bowl Sunday, days later even talking to the Denver Bronco’s team doctor to get the facts straight.

In fact it was not Imitrex® that broke Terrell’s monster Migraine as reported by most sports pages back then, rather it was a Migraine abortive medication called D.H.E. 45, a Dihydroergotamine ergot family drug which Terrell wisely had administered via injection during the prodrome phase of his Migraine.  So he was never in any pain because the D.H.E. 45 successfully aborted his Migraine about midway into the third quarter of the famous football game, after sitting out the second quarter of play and the extended Super Bowl halftime that is.  But the side effects of this older Dihydroergotamine such as numbness to the extremities (his hands and feet) would explain Terrell’s sluggish start and fumble in the beginning of the second half.  Anybody who has used D.H.E. 45 can tell you about their cold hands and feet with numbness and tingling, which can be annoying--but luck for most of us we are not catching any footballs.

But boy would have Terrell Davis loved to have had this new Migraine treatment about to go into phase three FDA clinical trials from MAP Pharmaceuticals.  They have created a new improved Dihydroergotamine and much better delivery system for the patient to take during their prodrome.  Remember sports fans, early intervention when it comes to our Migraines and our abortive meds.

So this MAP Pharmaceuticals company presented a poster summarizing the receptor pharmacology data entitled "Improved Dihydroergotamine (DHE) Pharmacology Following Orally-Inhaled Delivery." In addition to this study, the Company presented five posters relating to the MAP0004 program, including:

-- Newer Acute Migraine Specific Drugs May Provide Improved Sustained Relief and Freedom Over 24 and 48 Hours Post Dosing

-- Chronic Inhalation Toxicological Assessment of Dihydroergotamine in Dogs

-- Assessment of QTc Effect of DHE When Delivered Via the Lung by the Tempo Inhaler

-- MAP0004, an Orally Inhaled Formulation of DHE, Delivers Faster and More Consistent Blood Levels of the Drug Compared to Traditional Oral, Subcutaneous, Intramuscular, and Intranasal Formulations of DHE

-- Systemic Pharmacokinetics of DHE When Delivered Via the Lung to Asthmatics by the Tempo Inhaler

Terrell Davis would have appreciated a new improved dihydroergotamine with improved performance to defeat his Migraines.   So let’s see the data MAP Pharmaceuticals, Inc. presented from an in-vitro study evaluating receptor pharmacology of a new drug that the industry is calling MAP0004, orally inhaled dihydroergotamine (DHE) for the potential treatment of Migraine, and compared to intravenous (IV) DHE.

In the receptor pharmacology study, MAP0004 stimulated receptors that relieve Migraine at levels comparable to intravenous injection (IV) DHE, but did not activate receptors associated with side effects frequently seen with IV DHE. In addition, MAP0004 did not affect receptors that have a role in regulating pulmonary (lungs) function.

According to MAP Pharmaceuticals Chief Scientific Officer; "The selective binding of MAP0004 at receptors associated with Migraine rather than those associated with side effects offers a mechanistic hypothesis for the favorable safety and efficacy profile of MAP0004 compared to IV DHE that we have observed in our initial clinical studies,"  Thomas A. Armer, Ph.D., Chief Scientific Officer of MAP Pharmaceuticals went on to say: "The absence of negative effects of MAP0004 on pulmonary function in asthmatic subjects observed in a Phase 2 study is also important because migraine and asthma are frequently co-morbid conditions."

MAP0004 is designed to be self-administered by patients at home via MAP Pharmaceuticals' proprietary Tempo(R) inhaler. In Phase 2 studies with Migraneurs and with asthmatics, treatment with MAP0004 was well-tolerated, with no serious adverse events reported. Drug-induced nausea was very low and Migraine-associated nausea also decreased with treatment.

About MAP0004

MAP0004 is a proprietary orally inhaled version of dihydroergotamine, or DHE, intended to treat migraine. In the Company's Phase 2 efficacy study, MAP0004 provided pain relief as early as within ten minutes of dosing, and this relief was sustained through at least 24 hours. The study also demonstrated efficacy trends in treating nausea, photophobia and phonophobia. Based on these results, as well as independent research who conclude that patients prefer migraine therapies providing fast onset, pain relief, sustained pain relief and safety, the Company believes that MAP0004 has the potential to be a first-line therapy for migraine patients. Historically, estimated onset of significant pain relief with oral triptans, the class of drugs most often prescribed for treating migraine, occurs between 45 and 90 minutes after dosing. In 2007, triptans generated sales of approximately $2.2 billion in the United States, according to data published by IMS Health.

MAP0004 is designed to be an easy to use, non-invasive, at-home therapy that patients self-administer using the Company's proprietary hand-held Tempo inhaler. DHE is currently available as an intravenous therapy which has been used in clinical settings for over 50 years for the safe and effective treatment of migraine, but requires healthcare intervention for administration. In the Company's Phase 2 clinical efficacy study, MAP0004 was shown to retain the rapid onset and long-lasting effectiveness of intravenous DHE while avoiding the nausea that intravenous administration can cause.

About Tempo Migraine

MAP Pharmaceuticals is developing a series of inhaled respiratory and systemic drug products delivered with the Tempo(TM) Inhaler platform. The first of these products is a systemic migraine treatment that is designed to provide faster and more consistent relief than current therapeutics. In early human studies, Tempo Migraine delivered therapeutic blood levels within minutes of inhalation, similar to those seen after intravenous injection. This performance will potentially allow Tempo Migraine to mimic both the therapeutic blood levels and efficacy of injectable therapy - offering fast relief without injections. By providing rapid onset with a novel formulation of a proven compound (dihydroergotamine mesylate), MAP Pharmaceuticals seeks to meet the treatment needs of the large, underserved population of migraine sufferers with Tempo Migraine.

Last month MAP Pharmaceuticals issued a press release about the fact that it has initiated its Phase 3 clinical program to evaluate MAP0004 as a potential treatment for migraine.MAP0004 is orally inhaled and self-administered at home using MAP Pharmaceuticals' proprietary Tempo(R) inhaler. In the company's prior Phase 2 efficacy study, MAP0004 provided pain relief in as fast as 10minutes, with relief sustained through at least 24 hours. The study also demonstrated efficacy trends in treating nausea, photophobia and phonophobia, the other key measurements in treating migraine.

What impressed MAGNUM was the improved rapid effect of the drug to abort a Migraine attract and looks to offer sustained relief to 24 and 48 hours.  Something we hope to see this final phase of the FDA clinical trial bare out.

This randomized, double-blind, placebo-controlled Phase 3 trial is designed to evaluate the efficacy and safety of MAP0004 in treating acute Migraine. The primary efficacy endpoints will be pain relief, and freedom from nausea, photophobia and phonophobia as measured at two hours after dosing. MAP will also evaluate earliest onset of pain relief and sustained relief to 24 and 48 hours. The multi-center efficacy trial will include approximately 850 patients, who will also be followed for 12 months in an open-label study to confirm long-term safety.

"We believe that MAP0004 has the potential to be a first-line therapy for Migraine patients," said Timothy S. Nelson, president and chief executive officer of MAP Pharmaceuticals. "Based on our initial clinical studies, we believe that MAP0004 offers an alternative to triptans that may provide patients with the benefits of rapid onset and long-lasting pain relief, in an easy-to-use, non-invasive, at-home therapy. In our Phase 2 trials, MAP0004 was well tolerated with no effect on pulmonary function, including in asthmatic subjects."

MAP Pharmaceuticals is initiating the first Phase 3 trial of its MAP0004 product candidate pursuant to a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration. The SPA is intended to provide assurance that if pre-specified trial results are achieved, they may serve as the primary basis for an efficacy claim in support of a new drug application. In general, these assessments are considered binding on the FDA as well as the sponsor unless public health concerns unrecognized at the time the SPA is entered into become evident or other new scientific concerns regarding product safety or efficacy arise.

MAGNUM points out that there are Migraineurs who do not respond well to triptans and others who cannot use them, an improved dihydroergotamine mesylate administered with an improved oral delivery system in the Tempo® will be welcome in the Migraine community with open arms.  So we will be watching, and maybe even some new NFL players will too!

Regarding some of the benefits of the developmental medicine MAP0004 MAGNUM was talking about, here is a group of improvements the manufacture based on Phase 1 and 2 clinical studies, MAP Pharmaceuticals believes that MAP0004 may provide patients with the following benefits (when compared to existing therapies):

MAP0004 May Provide Patients With The Following Benefits

Rapid onset: Treatment with 0.5 mg of MAP0004 provided pain relief in as fast as 10 minutes of dosing.

Long-lasting: MAP0004 provided long-lasting pain relief with low incidence of recurrence.  Phase 2 studies support pain relief through at least 24 hours.

Broadly efficacious: Based on historical DHE use, MAP0004 may provide a higher response rate and has the potential to treat patients who have not previously responded to other therapies.

Convenient and consistent delivery: MAP0004 is non-injectable and easy to use, which results in increased patient comfort and compliance. Phase 2 studies were performed in the home, without clinical supervision and with minimal training.

Low incidence of side effects: Treatment with MAP0004 was well-tolerated, with no serious adverse events reported.

Note the MRI image with the lungs outlined in white, you can see limited coverage with the standard MDI 'puffer' design on the left and the unique and innovative design of the TEMPO (See the two blue illustrations of the TEMPO unit above.) to the right with the much better fuller disbursement of the dihydroergotamine seen here.

For more about other medicines under development or in clinical studies visit our partners at www.mymigraineconnect.com at the HealthCentral Network today.

FDA Acts On New Delayed Release Migraine Preventive Valproate Therapy In Easy-to-Swallow Soft Gel Capsule

A Smaller Better Delayed Release Version of Valproic Acid Capsules Available in August 2008

WASHINGTON, DC (July 31st, 2008)—As we reported back on October 23rd, 2007 that the U.S. Food and Drug Administration (FDA) had issued an approvable letter related to the New Drug Application (NDA) for Stavzor (TM) (A delayed release version of valproic acid capsules.) in 125mg, 250mg and 500mg strengths. The approvable letter relates to the use of Stavzor (TM) in the prophylaxis treatment of Migraine, the treatment of manic episodes associated with bipolar disorder, and adjunctive therapy in multiple seizure types including epilepsy.

In addition, on the same day, this past Tuesday the 29th  the U.S. Food and Drug Administration also approved the first generic versions of the FDA approved Migraine preventive Depakote delayed-release tablets (divalproex sodium).  For more about that please read MAGNUM's Teri Robert coverage at MyMigraineConnection when you are finished learning about Stavzor™.

We were excited with several Migraine drug improvements as this would give Migraineurs another Migraine preventive option to consider.  Obviously this is a variant of Abbott’s Depakote®.  But this version is a delayed release valproic acid capsules, which would be manufactured in a 125mg would most likely serve the Migraine needs.  We can now report that the FDA has issued an Approvable letter for the new formulation called “Stavzor™” with a delayed released valproic acid in capsule form.  We will have to see if the delayed release offers an advantage over the extended release on the market at this time.  But seeing as peoples psychology differ from person to person having a new delivery system should be a welcome Migraine preventive for many to consider.

According to the actual FDA document Migraine preventive use is actually covered.  It notes the following:

Prophylaxis of Migraine Headache

We are waiving the pediatric study requirement for ages 12-17 years for this indication because a previous study in that age group failed to demonstrate effectiveness for this indication. We are waiving the pediatric study requirement for ages 6-11 years for this indication because, in light of the previous negative study in the 12-17 age group, it is not expected that valproate would be shown to be effective in patients with migraine in ages 6-11 years. In addition, the necessary studies are impossible or highly impracticable (the critical design elements for adequate studies in this age group for this drug for this indication are unknown) . We are waiving the pediatric study requirement for ages 0-5 years for this indication because the necessary studies are impossible or highly impracticable (migraine is difficult to diagnose in children under age 6 years and the critical design elements for adequate studies in this age group for this drug are unknown).

This request for the FDA letter was submitted under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, references Abbott Laboratories’ Depakote® product, final approval is also subject to the expiration of any applicable exclusivity periods benefiting Depakote®. As I am sure most people who are familiar with valproic acid capsules as the Migraine preventive from the Epilepsy family called Depakote®.     Based on receipt of the approvable letter, interaction with Banner Pharmacaps Inc. (the NDA holder and developer of the product), and its understanding of Depakote® exclusivity, Noven was happy to get the expected Stavzor™ final approval, at three twenty-nine in the afternoon July 29th.

An excited Robert C. Strauss, Noven’s President, CEO & Chairman said;  “We are very pleased to announce that the FDA has issued an approvable letter for Stavzor™, and we offer our congratulations to the Banner and JDS teams for this successful result,”

“We are now working with Banner to satisfy the conditions to final Approval as expeditiously as possible. Banner has advised that it expects to respond to the FDA’s requests in the coming weeks. Concurrently, the Noven/JDS team has begun launch and production planning in anticipation of a 2008 launch of Stavzor™.”

With all due respect, it would have been nice of the Noven drug company CEO & Chairman if he might have made a remark about how the patient consumers, not just the stock holders will benefit from this new drug.  Don’t get me wrong, it is good to see more treatment options and development by the drug industry, it would just be nice to see more corporate attention to patient impact in their press releases as well.

 

Having said that, here is what Mr. Strauss’s company press release had to say for your perusal;

Noven Announces Final FDA Approval of Stavzor™ for the Treatment of Bipolar Disorder, Seizures and Migraine Headaches
New Delayed Release Valproate Therapy in Small, Easy-to-Swallow Soft Gel Capsule to be Available in August 2008

MIAMI--(BUSINESS WIRE)--Noven Pharmaceuticals, Inc. (NASDAQ:NOVN) today announced that the U.S. Food and Drug Administration (FDA) has approved Stavzor™ (valproic acid delayed release capsules) in 125 mg, 250 mg and 500 mg strengths. Stavzor is approved for the treatment of manic episodes associated with bipolar disorder, as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures, and for prophylaxis of migraine headaches. The product will be marketed and sold by Noven Therapeutics, LLC, Noven’s specialty pharmaceutical subsidiary, and is expected to be available in pharmacies in the second half of August.

Stavzor soft gel capsules are small (up to 40% smaller than Depakote® and Depakote ER® tablets at the 500 mg dosage strength) and easy to swallow, with an advanced enteric technology designed to reduce reflux and gastric irritability. Banner Pharmacaps Inc., Noven’s development partner for this product, developed Stavzor using its EnteriCare™ enteric soft gelatin capsule delivery system, and submitted the Stavzor New Drug Application to the FDA.

“Valproate, the active ingredient in Stavzor, is recommended by the American Psychiatric Association as a first-line therapy for patients living with bipolar disorder and experiencing manic episodes,” said Dr. Miguel Martelli, a psychiatrist in private practice in Georgia. “The small size and soft gel capsule formulation of Stavzor should make this new product easy to swallow, which in my experience is critical to helping valproate patients start – and stay on – their medication.”

“Our research indicates that valproate patients would prefer a small, soft gel capsule – like Stavzor – that is easy to swallow,” said Anthony Venditti, Noven’s Vice President – Marketing & Sales. “In a recent survey of 400 valproate users, more than two-thirds reported difficulty swallowing their other valproate medications, and 85 percent said they would have preferred a small soft gel capsule had it been available when initiating therapy. These are some of the patients who we expect to help with the launch of Stavzor.”

“The approval of Stavzor is an important development for patients who use valproate products and for our company,” said Peter Brandt, Noven’s President and Chief Executive Officer. “For patients, it represents a new, easy-to-swallow treatment option that may help with compliance. For Noven, it represents a significant step toward our goal of establishing Noven as a high-growth specialty pharmaceutical company.”

By visiting www.stavzor.com, consumers can access additional information on Stavzor and request a Stavzor Easy Save Pharmacy Card that can provide a significant savings off every co-payment. The Stavzor website also explains how the Stavzor Pharmacy Locator Service can help patients fill their Stavzor prescription at their preferred pharmacy. In addition, physicians can use the website to request Stavzor samples.

Important Product Safety Information about Stavzor

Valproate products should not be administered to patients with hepatic disease or significant hepatic dysfunction. Hepatic failure resulting in fatalities has occurred in patients receiving valproic acid and its derivatives, usually during the first six months of treatment.

Valproate may produce teratogenic effects in the offspring of women receiving the drug during pregnancy. Benefits of valproate should be weighed against risk of injury to the fetus in women of childbearing potential.

Cases of life-threatening pancreatitis, some rapidly progressing to death, have been reported in both adults and children receiving valproate. Valproate is contraindicated in patients with known urea cycle disorders (UCD), a group of uncommon genetic abnormalities, due to reports of sometimes-fatal cases of hyperammonemic encephalopathy. Concomitant administration of valproic acid and topiramate has been associated with hyperammonemia with and without encephalopathy.

The frequency of adverse effects, particularly elevated liver enzymes and thrombocytopenia, may be dose-related. Multi-organ hypersensitivity reactions have been reported after the initiation of valproate therapy. In a clinical trial of valproate in elderly patients with dementia, some patients taking valproate experienced somnolence, sometimes requiring discontinuation.

Common adverse events (greater than 5 percent incidence) associated with valproate in clinical studies were nausea, somnolence, dizziness, vomiting, asthenia, abdominal pain, dyspepsia, rash, diarrhea, increased appetite, tremor, weight gain, back pain, alopecia, headache, fever, anorexia, constipation, diplopia, amblyopia/blurred vision, ataxia, nystagmus, emotional lability, thinking abnormal, amnesia, flu syndrome, infection, bronchitis, rhinitis, thrombocytopenia, ecchymosis, peripheral edema, insomnia, nervousness, depression, pharyngitis, dyspnea and tinnitus.

                             # # #

Taking under advisement woman considering to have children you may want to discuss the risk factors for this or any anti-epilepsy Migraine prophylaxis medications.  Otherwise if this class of Migraine preventive medication if one that has worked well with you, or it is one you have not yet tried, you have some new options to discuss with your attending physician.  For more on this and other Migraine news visit our partners at MyMigraineConnection at the HealthCentral Network.

FDA Approved Anti-Epilepsy Migraine Preventive Drugs May Increase the Risk of Birth Defects

Research Looks At Popular Migraine Preventive & Discovers Possible Harm to the Fetus

WASHINGTON, DC; Updated July 27th; July 22th, 2008— In the past, Migraine tended to be managed in a way that either prescribed drugs that helped prevent attacks OR prescribed drugs that treated pain during an attack, but not both. However, the best approach to Migraine management is what MAGNUM calls a MULTIFACTORIAL approach, which involves addressing all four aspects of Migraine health care: preventive treatment, trigger management, abortive treatment, and general pain management.  What is preventive therapy you ask, and why is that particulaly important considering the headline? 

PREVENTIVE THERAPY

Preventive or, prophylactic, medications are prescribed to prevent or reduce the number of attacks in patients who experience frequent Migraines, typically two or more per month. In general, these medications act over time to prevent blood-vessel swelling; or certain chemicals in the brain are altered the person's sensitivity to a Migraine being triggered however, they do not treat the Migraine-associated symptoms and are non-selective. Many sufferers using preventive treatments will still have to take attack-aborting medications to relieve pain and other symptoms. Examples of conventional preventive therapy include: beta-blockers, antidepressants (for their effect on serotonin, not depression), calcium channel blockers, methysergide (potential serious side-effects), and anti-epilepsy medications Divalproex Sodium & Topiramate (alter brain chemistry). Examples of non-pharmacological preventive therapy include: vitamin B2 and magnesium supplements, Tanacetum Parthenium (Feverfew Leaf), and Petasites Hybridus (Butterbur root).

In recent years we have seen Epilepsy drugs in low dose used as a very effective Migraine preventive.  So much so that we get many e-mails telling us how Topamax® has change their life, or how they are seeing results with less Migraines and losing a few pounds too.  But there are also those who have scares with vision issues with Topamax and weight gain with Depakote®.  The point is for the first time we see a great number of Migraineurs compliant with their preventive care for their Migraine disease.

But seeing as how Migraines hit women disproportionatey hard, and how most are of child barring years this new study by AAN must be given serious consideration. 

The American Academy of Neurology in St. Paul, Minnesota reported the following regarding anti–epilepsy drugs for Migraine prevention; Taking the epilepsy drug topiramate alone or along with other epilepsy drugs during pregnancy may increase the risk of birth defects, according to a study published in the July 22, 2008, issue of Neurology®, the medical journal of the American Academy of Neurology.

Research has shown that many epilepsy drugs increase the risk of birth defects, but little research has been done on topiramate. Studies have shown that topiramate increases the risk of birth defects in animals. Maintaining effective epilepsy treatment during pregnancy is crucial because seizures may cause harm to the fetus.

For the study, researchers examined women who became pregnant while taking topiramate either on its own or along with other epilepsy drugs. Of 178 babies born, 16 had major birth defects. Three of these were in infants whose mothers were taking only topiramate, and 13 were in those whose mothers were taking topiramate and other epilepsy drugs.

Four of the babies had cleft palates or cleft lips, a rate 11 times higher than that expected if these women were not taking epilepsy drugs. Four male babies had genital birth defects, with two of those classified as major defects, which is 14 times higher than the normal rate for this defect.

"More research needs to be done to confirm these results, especially since it was a small study," said John Craig, MRCP, of the Royal Group of Hospitals in Belfast, Northern Ireland. "But these results should also get the attention of women with Migraine and their doctors, since topiramate is also used for preventing migraine, which is an even more common condition that also occurs frequently in women of childbearing age."

Craig said the risk of birth defects may be different for women taking the drug for Migraine, but that the pregnancies of women exposed to topiramate should be monitored.

This study found that more birth defects occurred in women taking topiramate along with the drug valproate, or valproic acid, than in women taking topiramate and another epilepsy drug. Research has shown that valproate is associated with a high risk of birth defects.

                                     ###

An Intimate Discussion With A Leader In Gut Brain Therapy™ for Migraine

Speaking From The Gut About A Natural Approach to Migraine Prevention

Illustration by MAGNUM 2008

WASHINGTON, DC; July 13th, 2008— Just a few weeks ago our friend and MyMigraineConnection correspondent Teri Robert recorded Dr. Fred Sheftell reading a message from Secretary of Health and Human Services Michael O. Leavitt who wrote: “Migraine disease is no longer sidelined as a symptom or a personality disorder, but now aggressively addressed as a progressive neurological disease with a genetic basis.  The good news is that compassionate, professional advocates and physicians like you are making a difference in the fight against headaches. Your tremendous work educating and informing the public helps so many escape the prison of their pain, and brings hope to those who suffer.”  Having said that, we are happy to report that our Executive Director Michael John Coleman had an opportunity to interview just one of those compassionate professional advocates the Secretary of Health remarked about so highly of in Boston at their 50th Annual Scientific Meeting of the American Headache Society.  The people "making a difference in the fight against Migraine" Secretary of Health Leavitt are talking about are people such as Mr. Tom Staverosky who created and is the President of ForeverWell, an over the counter completemary medicine company. Many of you who follow cutting edge Migraine treatmeants may enjoy the interview and learning more about the gut brain approach to Migraine care.

Michael John: We are chatting today with Tom Staverosky the President of ForeverWell, the developers of Gut Brain Therapy™. Here at MAGNUM we have been very intrigued by this natural approach to Migraine prevention and we wanted to get an update on their work. So Tom, what has the response been to Gut Brain Therapy™ and what do you see in the future.

Tom: Thanks Michael, I appreciate the opportunity to educate your readers a bit further on the potential role the gut brain is playing in Migraine disease. The first thing I should mention is that I think many people who look at our site are not getting a real clear understanding of how unique our work really is.

What I mean is people see our work and think we are simply saying that if people would just eat better their Migraines would go away. While we do believe that dietary choices can make a difference in how often and how severely migraine affects ones life, we are really going much deeper than that, and we clearly realize that preventing Migraine is much more complicated than dietary changes. 

Michael John: One of the things that I have found most interesting about the gut brain research is that 95% of the body’s serotonin is made in the gut and the gut brain utilizes not only serotonin but all of same neurotransmitters and neuropeptides that the brain uses and apparently most are made in the gut.

Tom: Wow, now you are really hitting the nail on the head Michael and that is what I mean when I say our work goes much deeper than dietary changes. It seems clear from the research that all these neurotransmitters are made in the gut and play a role both in the gut brain and the central nervous system. Part of what we are suggesting is that chronic inflammation and gut dysfunction is resulting in inadequate production of these critical components of proper neurological function whether it is in the gut brain or the head brain, or the peripheral nervous system for that matter.

Michael John: Are you saying that if the gut is not making the proper neurotransmitters and neuropeptides in the proper amounts at the right time that this might lead to Migraine attacks?

Tom: That is certainly part of our theory, along with the role of inflammation and the other effects of chronic digestive dysfunction. It is easy to forget just how critical the digestive system is to the human body. Clearly it is responsible for digesting the food we eat into the nutrient components that our cells need. For a long time researchers have shown that some 80% of the body’s immune function is in the gut and now the gut brain research is showing that the digestive system plays a critical role in the neurological systems of the body. One could easily make the argument that if the digestive system is not healthy, then the body cannot be healthy.

Michael John:So are the components of Gut Brain Therapy™ designed to simply help the digestive system work better or is it more focused on the production of neurotransmitters like serotonin?

Tom:  Actually, both. On the most simplistic level the combination of our Foundation Formula and Renew Formula are designed to improve the function of the digestive system and the liver and kidney. However, the small chain peptides that are the main component of Foundation Formula have been shown to contain the critical building blocks utilized by the gut to produce various neurotransmitters like serotonin. The peptide research also shows that these critical protein building blocks play an important role in making other body proteins including enzymes, hormones, tissue repair agents, growth factors, and all the other roles that protein plays in the body.

Michael John:So if the gut brain is healthy then your argument is that the rest of the body in general and the central nervous system in particular has a better chance of being healthy.

Tom:  Exactly. It is not that by getting the digestive system and liver/kidney working as well as possible that you can prevent every Migraine attack, but rather that if gut and liver are not as healthy as possible, you don’t have a chance. There is an increasing volume of research and discussion about the role of inflammation in Migraine disease and we are seeing that the inflammatory response begins in the digestive system and this is also likely playing a role in why Gut Brain Therapy™ is showing efficacy in reducing the duration and frequency of migraine attacks in so many of our customers.

Michael John: This is the third time you have mentioned inflammation in our discussion and perhaps we could invite you back in the near future to discuss your thoughts on the role it is actually playing in Migraine disease.

Tom:  That would be great, I look forward to our next discussion.

For more about the Gut Brain Therapy™ visit  ForeverWell's website, the developers of Gut Brain Therapy™ for Migraine prevention.

Secretary of Health Applauds 50 Years of the American Headache Society

AHS President & MAGNUM Chief Medical Advisor Dr. Fred Sheftell (L) who read Sec. Leavitt's letter during the opening ceremony & MAGNUM and MigraineBlog's Michael John Coleman (R) in Boston.

Secretary of Health Michael O. Leavitt Recognizes the Burden of Migraine Disease & those NGO's Who Fight It

Boston, MA; June 27th, Updated June 30th, 2008— In Boston today during the opening remarks of the largest gathering of neurologists in the nation, The President of American Headache Society Fred D. Sheftell M.D., F.A.C.P. announced he had a letter from the Secretary of Health Michael O. Leavitt which sent more than warm greetings for the 50th Annual Scientific Meeting of the American Headache Society.  Dr. Sheftell AHS's new incoming President is currently director and founder of The New England Center for Headache located in Stamford, Connecticut and he is Clinical Assistant Professor with joint appointments in the Departments of Neurology and Psychiatry at the Albert Einstein College of Medicine in New York City and consults at the Montefiore Headache Clinic and of course MAGNUM's Medical Advisor Chair. 

MAGNUM had spent months working with government officials to facilitate such a document which would highlight the government's continuing concern for Migraine disease and headache disorders, as we had in the past when Tommy Thompson became the first U.S. Secretary of Health to acknowledge Migraine as a major public health issue in 2003. The Office of Assistant Secretary of Health called the MAGNUM office on the 24th with great news that the letter was ready to be picked up at the Hubert H. Humphrey Building.  Just in time for MAGNUM to get the document to AHS in time for the opening ceremony up in New England. So it was fitting for Dr. Sheftell to read the official letter from the Secretary of Health and Human Services to the hundreds of the nation's leading Migraine and headache medical experts seated in the convention hall.

Mary Novick with the Office of Secretary of Health shown here handing the letter from theSecretary of Health to MAGNUM Executive Director Michael John Coleman at the Hubert H. Humphrey Building just in time for the AHS conference.

"We celebrate 50th Anniversary of American Headache Society and the 15th Anniversary of MAGNUM, the National Migraine Association. I applaud your efforts to raise national and global awareness of the epidemiology associated with migraine disease and headache disorders,"  noted Secretary of Health Michael O. Leavitt.

Secretary Leavitt highlighted how much more Migraine & headache is now taken seriously in his letter: "As we are winding down the "Decade of Pain Control and Research" migraine disease is no longer sidelined as a symptom or a personality disorder, but now aggressively addressed as a progressive neurological disease with a genetic basis."  As he echoes: "The good news is that compassionate, professional advocates and physicians just like you are making a difference in the fight against headaches. Your tremendous work educating and informing the public helps so many escape the prison of their pain, and brings hope to those who still suffer."

The Health Secretary also praises the work of notable non-government organizations in the headache world including the relatively new Headache On the Hill group; Alliance for Headache Disorders Advocacy (AHDA), Migraine Research Foundation (MRF) & our international friends and partners at the World Headache Alliance (WHA).

All and all, this letter makes a very powerful statement about the improved state of standing of Migraine disease and headache disorders in the medical community.  We are grateful to Secretary of Health Michael O. Leavitt for reinforcing the past Secretary of Health's commitment to the 36 million Americans who face the burden of Migraine disease on so many different levels.  With Dr. Robert Shapiro's work with other AHS doctors and all of us here at MAGNUM to convince NIH to fund research on headache disorders at adequate levels. The Health Secretary's support at the 50th meeting of these wonderful doctors who took on an unpopular disease a half century ago could not have come at a better time. 

MyMigraineConnection reporter and health advocate Teri Robert (L), Dr. Jerome Goldstein, and 'Ask The Clinician' Dr. John Claude Krusz, also a MAGNUM Medical Advisor, discussing the Boston AHS meeting while viewing the displays.

Because we believe with better government research, we can overcome NIH's inattention to headache disorders which has discouraged scientists from pursuing research in this field and contributed to the limited development of new Migraine disease and headache disorder therapies. But change is in the air, yes, the change we all keep hearing about! And it is happening at the 50th Annual Scientific Meeting of the American Headache Society. What we heard in Boston is very positive and we hope it continues.  We have much more to report on, with more great news from Capitol Hill happening during the Boston meeting, and exciting developments from Alliance for Headache Disorders Advocacy (AHDA) meeting in beantown so stay tuned.

For more on this subject from our partners at The HealthCentral Network please read "A Letter from a Secretary - About Migraine Disease and Headaches!" today.

GET THE LATEST INFORMATION ABOUT HEADACHE & MIGRAINE TREATMENTS FROM NATIONALLY RENOWNED NEUROLOGIST

Join iGuard.org For Free Patient Forum Today

Tuesday, June 17th at 8:00p.m. EST

LIMITED SPACE MAKE YOUR RESERVATION TODAY!!

WASHINGTON, DC; June 17th, 2008—(Updated from www.migraines.org New News last week.) MAGNUM would like to introduce our readers to a company called iGuard and suggest you make a reservation for tonight if you wish to learn about Migraine disease via a unique telephone forum & a exciting Migraine doctor!  Which is why we strongly suggest joining in with our friends at the iGuard tonight at 8:00PM.  As of today there is still some limited space left, if this sounds interesting read on.

Do you suffer from painful headaches, or debilitating Migraines that keep you from living life to the fullest? And do you worry about your future risk for stroke because you suffer from headaches or Migraines? If you answered yes to either of these questions, or just want to get up-to-date on the latest information on treatment options, please join the iGuard.org community for a free Patient Forum on Tuesday, June 17 at 8:00 p.m. EST via telephone to discuss this topic.  TONIGHT!

iGuard.org has invited board-certified medical neurologist, Dr. Jerome Goldstein, to host the forum. Dr. Goldstein is currently a member of The American Headache Society, The International Headache Society, The National Headache Foundation, & a MAGNUM recommend Migraine doctor. Terri & Michael John had met Dr. Goldstein during their travels for the World Headache Alliance, and when they attended various medical congresses of The American Headache Society, The International Headache Society when they hard carried letters from the United States Congress about the burden of Migraine disease--and while they covered those events over the years.  Dr. Goldstein is an internationally respected Migraine & headache disorder expert, and our readers are in for a treat if they have the time to participate.  We highly recommend it.  In addition, his special interest in the diagnosis, treatment, prevention and cure of headache. Dr. Goldstein was recently named President of the Headache & Facial Pain Section of the American Academy of Neurology. This is a rare chance to learn from a nationally-recognized expert about treatment options and expectations for your condition.

You must register with iGuard.org – a free and secure service which helps patients get informed, stay informed and share feedback about their medications. Currently, we  are now monitoring medication safety for over 250,000 Americans. 

To participate in this exclusive seminar, you must have access to a phone line where you can dial-in to a toll-free teleconference number; and then click the following link in order to RSVP:

http://www.iguard.org/seminar.html?hk=_uid&code=_code


iGuard have a limited number of places available for this free event and will only be accepting RSVPs through the above link on a first-come basis. You will receive an email confirmation of your registration and a PDF slide deck with Dr. Goldstein's presentation a few days prior to the seminar.

MAGNUM & iGuard hope that you can participate in this exciting event!