FDA Approves Two Medications for Migraine

The US Food and Drug Administration (FDA) recently approved two new drugs to treat migraine attacks, both of which are being heralded for their fast action. Sumavel DosePro® is a needle-free injection system that delivers a liquid form of sumatriptan (Imitrex®) directly through the skin (subcutaneously). Developed by Zogenix, Inc., the simple-to-use system provides relief from migraine pain within 10 minutes for some people.

“During market research sessions with healthcare providers and migraine patients, ‘cool’ was one of the most common responses to Sumavel DosePro—that’s a very unusual description in this industry,” said Roger Hawley, chief executive officer and director of Zogenix. Zogenix plans to have its product on the market as soon as possible.

Cambia® (diclofenac potassium oral solution), the second product approved by the FDA, is a nonsteroidal anti-inflammatory that also met many migraineurs’ need for faster pain relief. In studies, it showed statistically significant onset of pain relief within 15 to 30 minutes. It was also effective against light and sound sensitivity and nausea.

“Patients and physicians consistently mention rapid pain relief as most important when asked about primary attributes of a migraine medication,” said William Maichle, chief operating officer of Kowa Pharmaceuticals America, Inc. “We believe Cambia addresses these needs and will be a valuable addition to physicians’ migraine armamentarium.”

Kowa, which is marketing Cambia under license from Applied Pharma Research, expects the oral solution to be launched in the fourth quarter of 2009.


Source: http://www.headaches.org/2009/08/15/fda-approves-two-migraine-medications/

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