US regulators have approved, for the first time, a patch to treat migraine, claimed by its makers to be a "game-changing" new treatment option for sufferers - particularly for those also affected by related nausea.
The US Food and Drug Administration has issued a green light for NuPathe's Zecuity to relieve migraine-related pain and nausea, pushing the firm's shares up almost 19% in the hours after the news broke (though the stock levelled at close).
Zecuity is a single-use, battery-powered patch that actively delivers the most popular migraine medication sumatriptan - which has been on the market for years - through the skin.
The decision was based on Phase III data from some 800 patients using more than 10,000 patches, which showed that twice as many treated with Zecuity were free of headache pain at two hours compared with placebo (18% and 9%, respectively).
In addition, 84% of those treated with Zecuity were free from nausea at two hours compared to 63% of the control arm, offering a further benefit to patients.
According to study investigator Stephen Silberstein, Professor of Neurology and Director of the Jefferson Headache Center in Philadelphia, migraine-related nausea can be as debilitating as the pain of the headache itself, and "treatments bypassing the GI tract may be the best way to treat these patients."
Indeed, the American Academy of Neurology guidelines recommend a non-oral route of administration for migraine patients who experience nausea or vomiting, advice which could help give Zecuity a strong foothold in the market, despite its active ingredient having been on the block for some time.
Rejected in 2011
Back in 2011, the FDA rejected the patch on fears over its safety with regards to some skin reactions, issues which the firm has now evidently ironed out.
NuPathe said it is hoping to launch Zecuity in the fourth quarter of the year, and is intensifying its focus on securing commercial partners for the product.
Migraine affects around 30 million people - with around three times as many women as men - in the US alone.