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The US Food and Drug Administration (FDA) has – for the first time – approved a patch that delivers the active drug transdermally to relieve migraine-related symptoms.

By Louise Kelly on Jan 23, 2013

Migraine affects over 30 million people in the US alone. In a study published online by Migraine.com last year, only 34% of migraine patients responding to the survey reported satisfaction with their existing migraine treatment. These sufferers will no doubt be celebrating the fact that the US Food and Drug Administration (FDA) has – for the first time ever – approved a patch that delivers the active drug transdermally to relieve migraine-related symptoms.

The recently sanctioned treatment, NuPathe's Zecuity, is a single-use, battery-powered patch that actively delivers the migraine medication sumatriptan through the skin. For many people with migraine attacks, triptans are chosen as the alleviation method. They are effective in relieving the pain, nausea, and sensitivity to light and sound that are associated with migraines. Working by reducing vascular inflammation in the brain, sumatriptan was first approved as an oral drug in 1991, and has been widely used to treat migraine and cluster headaches ever since.

According to 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.”

The Zecuity patch uses electricity to exchange ions with the skin to deliver sumatriptan. In 2011, the FDA had rejected a different NuPathe application for a similar sumatriptan patch called Zelrix. The earlier design had flaws – exposed electrodes – that gave some patients minor burns but the approved model has a pad detection system that prevents this type of reaction.  NuPathe CEO Armando Anido said of the initial 2011 rejection: "There were 7 patients out of 10,000 who had small burns from the patch ... and the FDA told us to go ahead and fix it."

And it seems that is exactly what NuPathe did. Regulatory approval for the improved product, Zecuity, followed successful phase III clinical trials involving 800 patients. During the entire four-hour dosing period, a microprocessor inside Zecuity continuously monitors skin resistance and adjusts the delivery of sumatriptan accordingly to ensure the correct dosage (6.5 mg) of the drug is delivered.

But while NuPathe looks for a commercial partner as it starts manufacturing the patch for a Q4 release date, researchers over in Queensland have suggested a simpler – and no doubt cheaper – migraine remedy.  Their novel treatment is based on genetic links, built from vitamin supplements and aims to address the migraine symptoms in 20% of sufferers.  Years from release and as yet unauthorised, however, patients are more likely to opt for the soon-to-be-released medicinal patch.