Millions of Americans who suffer from migraine will soon have a new treatment option – one that doesn’t come in a bottle or pill. It’s a battery powered patch that acts as a new delivery system for an old drug – without the nausea that oral medications can cause.
The Food and Drug Administration set aside previous reservations and granted approval for Zecuity, a patch that delivers sumatriptan through the skin, for treatment of migraine headache and migraine related nausea. The Zecuity transdermal patch is applied to the upper arm or thigh and, when activated by a push button, delivers sumatriptan over the course of 4 hours.
Sumatriptan is a triptan, a class of drugs already widely used to treat migraine and cluster headaches. It works in the brain by reducing vascular inflammation. Sumatriptan was first approved as an oral drug in 1991. It can also be injected or inhaled.
“The approval of Zecuity represents a major milestone for NuPathe and migraine sufferers,” said Armando Anido, CEO of NuPathe (NASDAQ: PATH), which makes the patch. “As the first and only FDA-approved migraine patch, we believe Zecuity will be a game-changing treatment option for millions of migraine patients, especially those with migraine-related nausea.”
NuPathe is seeking commercial partners to help it launch Zecuity in the fourth quarter of 2013.
In 2011, the FDA rejected another NuPathe application for a similar sumatriptan patch called Zelrix. The agency cited concerns about the patch’s safety, chemistry and manufacturing.
Regulatory approval for Zecuity came after phase III clinical trials in which 800 patients used over 10,000 Zecuity patches or a placebo. Over half of the patients using Zecuity had relief from migraine headache, compared to just 29 percent in the placebo group. In addition, 84% of the patients using Zecuity arm were nausea free after two hours, compared to 63% of the patients treated with a placebo.
“Migraine-related nausea can be as debilitating as migraine headache pain itself,” said study investigator Stephen D. Silberstein, MD, Professor of Neurology and Director of the Jefferson Headache Center in Philadelphia. “Treatments bypassing the GI (gastrointestinal) tract may be the best way to treat these patients.”
Common side effects from Zecuity include itching, tingling or pain where the patch is applied. Most patients experience skin redness after they remove the patch. The redness usually disappears after 24 hours.
Zecuity is not recommended for people with a history of heart disease, stroke or high blood pressure.
About 31 million adult Americans suffer from migraine. It affects about three times as many woman as men. In addition to headache pain and nausea, migraine can also cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound.