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Regulatory Focus™ > News Articles > FDA Evaluating Risk of Burns and Scars With Migraine Patch

FDA Evaluating Risk of Burns and Scars With Migraine Patch

Posted 02 June 2016 | By Zachary Brennan 

FDA Evaluating Risk of Burns and Scars With Migraine Patch

Almost five years since the US Food and Drug Administration (FDA) rejected the approval of the Zecuity migraine patch because of burns (and then later approved a revamped version), the agency said Thursday it’s now investigating the battery-powered patch as “a large number of patients have reported they experienced burns or scars on the skin where the patch was worn.”

The evaluation comes as the patch, which delivers sumatriptan and should remain in place for no more than four hours, was approved in 2013 and marketed in September 2015. The patch’s original developer, NuPathe, which was acquired by Teva Pharmaceuticals for $144 million in 2014, had to redesign the product after FDA rejected the device over safety concerns with burns.

"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," NuPathe CEO Armando Anido told Fierce in 2013 of the August 2011 rejection. "After the redesign, they complimented us on it."

Latest Warning

But now, FDA says patients experiencing “moderate to severe pain at the Zecuity patch site should immediately remove it to avoid possible burns or scarring,” regardless of how long the patch has been worn. Patients were also instructed not to bathe, shower or swim while wearing the patch.

Patient reports of side effects with the patch included “descriptions of severe redness, pain, skin discoloration, blistering, and cracked skin. As a result, we are investigating these serious adverse events to determine whether future regulatory action is needed,” FDA said.

The safety warning comes as FDA earlier this week issued new draft guidance on ways companies can design studies to demonstrate the adhesive performance of transdermal delivery systems and topical patches.

FDA Drug Safety Communication

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