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“New” Migraine Drugs

I’m so tired of seeing articles announcing a new migraine drug is in development, then discovering it’s an old drug with a different delivery system. These are not new drugs, even though press releases pretend that they are.

The investigation and marketing of these new routes will help patients. Gastric stasis and vomiting can impair the efficacy of a swallowed medication, so being able to bypass these complications is beneficial. Some people who have never gotten relief from a triptan before may find that they suddenly work when taking as an injection, nasal spray, patch or oral film. These are important points, but they don’t add up to something being a new drug.

If new migraine abortives were also being developed and reported, the investigation into new delivery routes for old drugs probably would not bother me. The problem is that I so desperately want new migraine drugs to be in development that these announcements always raise my hopes.

I know better, I really do. And knowing that — what the migraine research landscape looks like — may be the bleakest part of it all.

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ACT NOW: Tell the FDA Why Migraine Matters!

Please, please, please help get migraine included in the FDA’s exciting new patient-focused program by telling them how desperately migraine needs their attention. Inclusion would mean way more time and money spent on — and research and drug development for — this life-altering illness that is typically dismissed as “just a headache.” The deadline is next week, so don’t delay.

Program Overview
In this new program, the FDA will choose 20 illnesses and host a meeting on each illness for patients, caregivers, physicians and other interested parties to cover an “in-depth review of the needs related to treatment, the current state of treatments, disease burden, the human side of living with the disease, and other issues of possible relevance to reviewing treatments that may come before the FDA for review,” according to patient advocate Teri Robert.

What You Can Do
The FDA is currently accepting public comments to help decide which illnesses should be included in the 20. This is where you come in — I beg you to submit a comment highlighting the importance of studying migraine. For most impact, it should be concise, focused and not overly emotional. Comments are due by next Thursday, November 1, so please don’t wait.

Topics to Address in Your Comment
The FDA is specifically looking for the following criteria when deciding the diseases to include in the program. Please address as many as are relevant to you in your comment.

  • Disease areas that are chronic, symptomatic, or affect functioning and activities of daily living
  • Disease areas that reflect a range of severity
  • Disease areas for which aspects of the disease are not formally captured in clinical trials
  • Disease areas that have a severe impact on identifiable subpopulations (such as children or the elderly)
  • Disease areas that represent a broad range in terms of size of the affected population
  • Disease areas for which there are currently no therapies or very few therapies, or the available therapies do not directly affect how a patient feels, functions, or survives.

Facts and statistics you may want to include in your comment, which Teri Robert put together.

Where to Submit Your Comment
Submit your comment at FDA’s Prescription Drug User Fee Act Patient-Focused Drug Development Public Meeting and Request for Comments page and click the blue button that says “comment now.”

More Information

A Final Plea
Putting together your comment may take a little time, but it might make the difference in getting migraine recognized as a real and debilitating illness. This will lead to more funding for research into treatments and causes of migraine. Such discoveries could benefit you in the future and will certainly help your children or other young loved ones who have migraine.

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CGRP Receptor Antagonist a Promising New Migraine Abortive Drug

Calcitonin gene-related peptide (CGRP) receptor antagonist MK-0974 holds promise as a migraine abortive, according to Phase II study results that will be presented at the American Headache Society‘s annual meeting this week.

The drug works by blocking CGRP, a brain chemical that is important for transmitting pain signals during a migraine. It does not appear to contrict blood vessels, as triptans do, so people who can’t use triptans may be able to use MK-0974 as an abortive. Researchers hope that it will have fewer side effects and safety concerns than triptans do.

The American Headache Society’s press release on the study follows.

New Migraine Drug Holds Promise for Headache Sufferers: First Class of Migraine Medication Since the Triptans

CHICAGO – An innovative drug appears to treat migraines in a majority of people, potentially ushering in a new era for the treatment of the painful and disabling headaches, suggests early research being presented at the 49th Annual Scientific Meeting of the American Headache Society.

The study is the first presentation of a drug called MK-0974, which belongs to a potential new class of drugs, known as calcitonin gene-related peptide (CGRP) receptor antagonists.

Fifteen years ago, the advent of triptan medication revolutionized migraine treatment by stopping the headaches and related symptoms, rather than just providing pain relief. However, triptans don’t work for about a third of the estimated 28 million people with migraines and because they constrict blood vessels, they cannot be used in patients who have had a heart attack or stroke and should be used with caution by those who are at risk.

“The real excitement is that this drug has a different mechanism of action from the triptans, and the hope is that it will have fewer side effects and safety concerns,” said Alan M. Rapoport, M.D., clinical professor of neurology at the David Geffen School of Medicine at UCLA, in Los Angeles, and a co-author of a study on the drug being presented at the Society’s meeting.

The new drug works by blocking CGRP, a brain chemical that is important for transmitting pain signals during a migraine attack. Unlike the triptans, research has shown that the new drug does not appear to constrict blood vessels.

“Because we know that the CGRP level is elevated during a migraine attack, and that if you give CGRP intravenously, you can cause a migraine-like headache, we’ve been studying what would happen if you block the CGRP,” said Tony Ho, M.D., senior director of clinical neuroscience at Merck & Co., Whitehouse Station, N.J. “Our hope is that this drug potentially can have a significant impact for migraine patients as an additional treatment choice.”

The new drug has not been approved by the Food and Drug Administration (FDA). Results from the Phase II study being presented at the Society meeting are an early step in the development process.

The randomized, double-blind, placebo-controlled study tested safety and effectiveness of MK-0974 and involved a total of 330 people who suffered one to six migraines a month. Study patients kept a diary to assess: pain relief two hours after taking the medication, pain freedom two hours after taking the medication, and freedom from pain 24 hours later.

More than two-thirds (68 percent) of those who took the 300 mg dose of the new drug had pain relief two hours after the dose, compared to 69.5 percent of those who took the FDA approved triptan called rizatriptan and 46 percent who took a placebo, or dummy pill. Nearly half (45.2 percent) of those who took the new drug were free of pain after two hours, compared to 33.4 percent who took rizatriptan [Maxalt] and 14.3 percent who took the placebo.

More than a third (39.6 percent) were free of pain 24 hours after taking the new drug, compared to 18.4 percent who took rizatriptan and 11 percent who took the placebo. Common side effects included nausea, dizziness and sleepiness.

“These early results are very promising,” said Dr. Ho. “There’s potential for the new drug to be superior to the triptans 24 hours after the medication is taken, but this needs to be confirmed in a larger trial.”

“There’s good reason to believe that at least some people would respond to this drug, even if they did not respond to the triptans,” said Dr. Rapoport, who also is the cofounder and director emeritus of The New England Center for Headache, in Stamford, Conn. “Also, additional data suggest that this drug gets into the blood stream fairly quickly and may stay in the blood stream longer than several of the triptans.”

In addition to Drs. Rapoport and Ho, other authors of the paper being presented at the meeting are: Lisa Mannix, M.D., Xiaoyin Fan, Ph.D., Chris Assaid, Ph.D., Christine Furtek, M.S. and Chris Jones, M.S.