FDA Considers Treximet for Adolescent Migraineurs

In potential good news for adolescent migraineurs, the U.S. Food and Drug Administration has accepted a supplemental New Drug Application (sNDA) for Treximet, a combination medication containing sumatriptan and naproxen sodium.

treximetWith the agency’s approval, Treximet would become the first sumatriptan or combination prescription medication for the treatment of acute migraine attacks with or without aura for migraineurs ages 12 to 17. Currently, Treximet is approved only for acute migraine treatment in adults.

Treximet manufacturer, Pernix Therapeutics, based in Morristown, New Jersey, has indicated it expects FDA approval in the second quarter of this year.

Doug Drysdale, the company’s chief executive officer, noted that Pernix is pleased to be moving ahead with the FDA approval process.

“We believe that Treximet has the potential to make a meaningful difference in the lives of adolescent migraine patients, and we look forward to continuing to work with the FDA in its review of the Treximet sNDA,” he said in a company press release.

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Study Determines Most Effective Migraine Medications

Several medications were recently deemed the most effective for treating acute migraine, including triptans, dihydroergotamine (DHE), nonsteroidal anti-inflammatory drugs (NSAIDS), butorphanol nasal spray, and the combination medication of sumatriptan/naproxen and acetaminophen/aspirin/caffein). Several other migraine medications were considered “probably effective” or “possibly effective.” Continue Reading

AVP-825 Nears Possible FDA Approval

OptiNoseA new device showing promise in migraine treatment is growing closer to potential approval by the United States Food & Drug Administration (FDA).

The Pennsylvania-based company, OptiNose, recently announced that a pivotal phase III study evaluating the efficacy and safety of  the device, called AVP-825, will be published in the January 2015 issue of Headache, The Journal of Head and Face Pain. The study is currently available on the journal’s website through its early access feature. Continue Reading