Zelrix Migraine Patch – FDA Approval Delayed

September 6th, 2011 - Posted by Teri Robert

Migraine patients who find oral medications don’t work well for them have been anxiously awaiting word of FDA approval of NuPathe, Inc.’s sumatriptan patch Zelrix.

On August 30, NuPathe received a Complete Response Letter (CRL) from the FDA regarding the New Drug Application (NDA) for Zelrix. A CRL is issued by the FDA’s Center for Drug Evaluation and Research when the review of an NDA is completed and questions remain that preclude the FDA from approving the NDA at the time.

Sumatriptan is the triptan that was originally the brand name Imitrex, so sumatriptan is hardly new. One might think that made approval of Zelrix simple and somewhat a “no-brainer.” Not so. The Zelrix patch is a novel delivery system, and that made the approval of Zelrix more complex. In the CRL, the FDA acknowledged that NuPathe had established the efficacy of Zelrix. The CRL primarily contained chemistry, manufacturing and safety questions, which the Company believes it has, or shortly will have, sufficient data to address. The Company may conduct additional Phase I and/or non-clinical studies to address other questions. NuPathe has requested an End-of-Review meeting with the FDA to discuss the CRL and NuPathe’s approach to resolving the outstanding issues.

In an interview, Jane Hollingsworth, CEO of NuPathe, told me,

“We are disappointed in the delay in obtaining FDA approval for our patch but remain no less committed to working hard to bring this new migraine medicine to market as soon as possible. As a migraine sufferer, I know firsthand the problem that nausea with migraine causes. That is why we have been working the last six years to develop a migraine patch for patients.”

http://migraine.com/blog/zelrix-migraine-patch-approval-delayed/