FDA approves first-ever migraine medicine skin patch

fda logo FDA approves first ever migraine medicine skin patchNuPathe is launching the first-ever patch to treat migraine headache, a product the device’s maker says is “game changing” to migraine sufferers. The Food and Drug Administration (FDA) gave NuPathe’s Zecuity the nod last week, and the company says it is currently focusing on securing commercial partners for the patch and hopes to have the patch on the market by the end of the year.

Zecuity is a single-use, battery-powered patch that actively delivers the migraine medication sumatriptan through the skin. Sumatriptan has been on the market since 1991. It is administered in several forms including tablets, subcutaneous injection, and nasal spray. The drug works the fastest when injected, however the effects last for a shorter time.

Migraines are debilitating headaches that often are accompanied by nausea and vomiting. The American Academy of Neurology guidelines recommend for migraine patients who also suffer from nausea or vomiting to be given non-oral versions of sumatriptan, which may make the Zecuity patch a more attractive option for patients.

Zecuity was approved by the FDA based on Phase III data from about 800 patients who combined used more than 10,000 patches. Twice as many of the patients who used the patch found pain relief from their headache after two hours compared to patients who were given placebo. Nearly all – 84 percent – of patients treated with the patch also found relief from nausea after two hours, compared to 63 percent of patients who were given the placebo.

This is the second time the FDA has reviewed Zecurity for the treatment of migraine headaches. In 2011, the agency rejected the patch citing concerns over skin reactions.

Source: PharmaTimes