FDA Declines to Approve Migraine Patch

NuPathe Inc. announced that the FDA has declined to approve its migraine patch drug Zelrix, raising questions about its chemistry, manufacturing, and safety.

NuPathe Inc. announced yesterday that the FDA has declined to approve its migraine patch drug Zelrix. According to the company, the complete response letter it received acknowledged that the efficacy of the patch had been established, but raised questions about its chemistry, manufacturing, and safety. The company may need to conduct additional studies in order to address some of the FDA’s questions and will not be launching the patch in the first half of 2012 as previously planned.

The patch allows for non-oral administration of sumatriptan, the most widely prescribed migraine medication, and is designed for acute treatment of migraine to provide relief for the primary migraine symptoms including headache pain, nausea, and sensitivity to light and sound.

Source

FDA Requests Additional Information Regarding NuPathe's Migraine Patch in Complete Response Letter [Press Release]