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This month, just prior to June Migraine Awareness Month, AMD is providing a comprehensive update on the FDA’s news and approvals of migraine medications. We think this is useful as it gives you a longitudinal look at the most current developments in migraine research including approvals, drugs in clinical trials, and recent industry news which could impact treatment options down the road.

12 month FDA Migraine Medication/Device Approvals

The FDA has approved Avanir’s acute migraine medication, “Onzetra Xsail” for the treatment of acute migraine. This includes migraine with or without aura. Essentially this is a newer take on an older medication with a newer delivery device. Sumatriptan has been approved in the past in other delivery forms. Hopefully, this will be quicker and have greater bioavailability.
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Pernix’s Treximet a medication for children with migraines is approved by FDA. Treximet (Sumatriptan and naproxen sodium) is the first FDA approved combo- medication, and also the first Sumatriptan product, used to treat migraine in children. Sumatriptan is in a class of drugs that constrict CNS (brain) blood vessels to reduce swelling. Naproxen is a nonsteroidal anti-inflammatory drug, which must also be used with caution. An adult formulation of Treximet has been available since 2008.
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Cefaly is a headband device, originally developed in Europe, that relieves migraines via tiny non-painful electrical jolts to the head. It has enjoyed reasonable success in peer reviewed trials, and scores of anecdotal success stories. It is now available in the United States.
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In Clinical Trials

Alder Biopharmaceutical’s ALD403 successfully concluded its primary and secondary endpoints in a Phase 2b study. ALD403 prevents migraines by blocking calcitonin gene-related peptide, or CGRP, a protein that earlier studies have shown plays a role in the start of migraines and increased sensitivity to pain when experienced. This is one of the promising CGRP antibodies so hotly pursued by a number of pharmaceutical companies. These results, from late March 2016, promise a race to the finish line.
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Amgen and Novartis are involved in a neuroscience drug partnership to develop and bring to market new inhibitors to fight Alzheimer’s disease and treat migraines. Initially, the partnership will center on Novartis’ Phase 1/2a oral beta-site APP-cleaving enzyme-1 inhibitor CNP520, with other BACE inhibitors in the pipeline. This complex partnership is an example of the overlap between several neurological disorders and the corporate re-positioning that is occurring as a result. As we have said before a multi-disciplinary approach is required to resolve these issues. Phase 3 migraine trials expected next year.
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Amgen may be inching ahead in the clinical trials horse race with AMG334 in Phase 3 this month, testing safety and efficacy. One in the CGRP group to keep an eye on. This area is the best and brightest hope for migraine prevention.
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Industry News

Within the last 9 months, Dublin, Ireland-based Allergan has reached an agreement to obtain international rights to both Merck’s oral calcitonin gene-related peptide (CGRP) receptor antagonists to treat migraine. Merck apparently ran into difficulties, with, among other things, liver toxicity in clinical trials. So time to unload. It gets even more intriguing.

Allergan will pay $250 million upfront and another $125 upon Hart-Scott-Rodino antitrust clearance, and the other $125 million on April 2016. No news on that payment yet, and it’s April. Remember Allergan just had its merger with Pfizer nixed because of the tax inversion question.

Anyway, the agreement states, Allergan will be exclusively in charge of the CGRP program development, as well as the manufacturing and marketing components. That’s if it gets approved. We’ll be watching. Another entry in the CGRP horserace.
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eNeura has been granted a CE mark label extension for its SpringTMS to include migraine prevention. The label extension adds to the existing SpringTMS CE Marking for acute treatment of migraine. The United Kingdom National Institute for Health and Care Excellence (NICE) issues guidance recommending single-pulse Transcranial Magnetic Stimulation (sTMS) for acute and preventative treatment of migraine. Studies have yielded positive results, gathered over the last 5 years. SpringTMS also has 510(k) clearance from the U.S. Food and Drug Administration for the acute treatment of pain associated with migraine headache with aura. 510(k) essentially means the FDA has granted clearance to pre-market. Clearance of a Premarket Notification submission gives permission to market the new device, often because of its similarity to other, approved devices.

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