New Class of Migraine Preventives Raises Excitement and Hope

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When we look for effective migraine preventive medications today, we find that there are no medications available that were developed for migraine prevention. Not a single one. We have some fairly effective preventive medications available, but they were all originally developed for other conditions, then found to also be helpful for migraine prevention.

BUT, migraine researchers and clinicians are growing excited about a new class of medications called Calcitonin Gene-Related Peptide (CGRP) monoclonal antibodies, which are showing promise in treating high-frequency episodic migraine and chronic migraine. Now that news is coming out about this new class of medications, migraine patients are becoming increasingly excited too.

Dr. Peter J. Goadsby, who is chair of the scientific program of the American Headache Society’s annual Scientific Meeting, Chief of the UCSF Headache Center, and one of the world’s leading headache treatment experts and researchers commented:

"This development is a transformative moment in migraine treatment. There’s no question that we need something better. In fact, for prevention we really need something designed specifically for migraine," he said, noting that there has not been a new class of anti-migraine drugs since the development and marketing of triptans in 1991 and they are not preventives, just designed to treat migraine attacks. "Up till now, migraine patients have had limited choices for preventive treatment. Now four pharmaceutical companies are showing positive results in human trials targeting CGRP mechanisms."1

"The potential of these new compounds is enormous and gives us real hope that effective specific treatments for migraine may be on the near horizon. The development of CGRP antibodies offers the simple, yet elegant and long awaited option for migraine patients to finally be treated with migraine preventives; it’s a truly landmark development."1

The new class of therapeutic agents appears to reduce elevated levels of the peptide known as calcitonin gene-related peptide (CGRP), a key driver of migraine pain. Versions of anti-CGRP therapies are being tested by Alder Pharmaceuticals, Amgen, Eli Lilly and Company, and Teva Pharmaceuticals. To better understand CGRP and these new medications, we asked Dr. Goadsby to explain them. Check out the video of his explanation in New CGRP Monoclonal Antibody Migraine Preventives - VIDEO.

Reports on their Phase II clinical trials were presented at the meeting. Phase II clinical trials are, "Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition). For example, participants receiving the drug may be compared with similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied."5

Teva's TEV-48125:

Teva reported for the first time that its drug, as a preventive treatment of high frequency episodic migraine, achieved a significant reduction in the number of headache hours after one week, with more than half of patients in each arm experiencing a 50 percent or greater reduction in migraine frequency.

Amgen's AMG 334:

Amgen reported on 383 patients who completed the double-blind trial and entered the open-label extension phase of their trial for up to 256 weeks. AMG 334 reduced the number of migraine days by 50 percent in about half the treated patients after 12 weeks. 3

Lily's LY2951742:

Lilly presented, for the first time, Phase II data in episodic migraine that establishes the efficacy of their medicine against placebo with monthly administration across a range of doses. Their trials provided evidence that monthly subcutaneous injections of 120 mg of LY2951742 are safe, tolerable and efficacious in the prevention of episodic migraine, and support previous proof-of-concept study findings.

Alder's CGRP Drug:

Alder Pharmaceutical, the fourth player in the CGRP race, is also developing an anti-CGRP drug with positive phase II data published, but did not present further data at the meeting.

With Phase II trials complete, these medications can now enter Phase III trials, the last phase of trials conducted before they're submitted to the FDA for approval. Phase III trials gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

It will still take a few years to conduct the Phase III trials and get these medications approved by the FDA, but at this point, signs are encouraging. We're finally seeing the development of medications specifically for migraine prevention. Unlike most of the medications now in use for migraine prevention, which are taken orally daily, the CGRP drugs are injected subcutaneously, once a month.

I'll be following the progress of the clinical trials of these medications and will bring you updates as they're available. In the meantime, the development of these medications is very encouraging and great reason for hope.

More interesting information from the American Headache Society's annual scientific meeting:


Sources:

1 Press Release. "Migraine Community Sees Promise in New Class of Drugs: Optimistic for Relief for Millions of Sufferers." American Headache Society. Washington, D.C. June 17, 2015.

2 Sklarevski, V.; Zhang, Q.; Ferguson, M.B.; Oakes, T.M.; Martinez, J.M.; Johnson, K.W.; Schadt, A.L.; Due, M.R.; Dodick, D. W. "Efficacy and Safety of LY2951742 in a Phase IIb, randomized, double-blind, placebo-dontrolled, dose-ranging study." Research Presentation, 57th Annual Scientific Meeting of the American Headache Society. Washington, D.C. June, 2015.

3 Sun, Hong; Dodick, David W.; Goadsby, Peter; Silberstein, Stephen; Reuter, Uwe; Ashina, Messoud; Saper, Joel R.; Cady, Roger; Zhang, Feng; Trotman, Marie-Louise; Dietrich, Julie; Lenz, Robert. "Results of the Open-Label Extension of a Phase 2, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of AMG334 for the Prevention of Episodic Migraine." Research Presentation. 57th Annual Scientific Meeting of the American Headache Society. Washington, D.C. June, 2015.

4 Bigal, Marcelo; Rapoport, Alan; Tepper, Stewart; Ma, Mary; Silberstein, Stephen. "Tev-48125 for teh Preventive Treatment of Chronic Migraine - Efficacy at Early Time Points." Research Presentation. 57th Annual Scientific Meeting of the American Headache Society. Washington, D.C. June, 2015.

5 ClinicalTrials.gov. "Glossary of Common Site Terms." February, 2015.

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