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New Gel Shows Promise in Treating Migraine

A pain-relieving gel in the pipeline for treating migraine appears safe and effective, and may provide a new treatment option after further testing.

In a phase 2a clinical trial, 48 adults with episodic migraine with and without aura treated five migraines by applying the gel Topofen on the skin over the three branches of the trigeminal nerve in the temple area. Of those with severe migraine, 45% experienced sustained pain relief from 2 to 24 hours after treatment compared to 15% with a different pain-relieving gel with the same active ingredient, the nonsteroidal anti-inflammatory drug (NSAID) ketoprofen. Additionally, patients whose severe headaches were treated with Topofen were at least 3 times as likely to experience complete relief of associated symptoms, such as nausea and photophobia, as those who were treated with the placebo.

The clinical trial was conducted by scientists from the North Carolina-based pharmaceutical company Achelios Therapetics and the Michigan Headache & Neurological Institute of Ann Arbor, Mich. The results were presented at the American Academy of Neurology’s annual meeting in Washington, D.C. last month.

“The positive results of this study provide preliminary evidence that migraines can be effectively treated topically without the safety and side effect challenges that often accompany systemic oral medications,” said Crist Frangakis, PhD, president and CEO of Achelios, in a press release.

The drug works by accumulating in tissues, rather than circulating in the blood, and the goal is for the drug to be used preventatively, Dr. Frankagis added.

Considerable further testing is needed, but those involved say an additional benefit of the medication is that it could help address medication overuse headaches, which frequently occur when oral NSAIDS are taken more than 15 days per month.

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