Teva Pharmaceutical Industries has suspended sales of its migraine patch Zecuity following post-marketing reports of burns and scars in patients.
The drugmaker said it has been notified of application site reactions, and is now working “in full cooperation with” the US Food and Drug Administration to better understand these adverse events.
As well as pausing sales of the patch, Teva said it has initiated a pharmacy-level recall of the product and issued a Dear Health Care Provider Letter to alert the prescribing community, while it investigation the root-cause of the issue.
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 patch was approved in the US in December 2013 after Phase III data from some 800 patients – using more than 10,000 patches – showed that twice as many treated with Zecuity were free of headache pain at two hours compared with placebo (18 percent and 9 percent, respectively).
It was previously rejected by the US Food and Drug Administration in 2011, on fears over its safety with regards to some skin reactions.
