FDA Turns Down Migraine Patch - Drug Discovery and Development

CONSHOHOCKEN, Pa. (AP) – NuPathe Inc. said that regulators did not approve its Zelrix migraine patch.

NuPathe said the Food and Drug Administration wants more information on the chemistry and manufacturing of Zelrix, and also had concerns about the safety of the patch, its lead product candidate. NuPathe, which has no products on the market, said it has data that can address some of the agency’s questions and it will have other relevant data shortly. However the company may conduct additional studies, possibly including early-stage trials on human subjects. As a result, NuPathe won’t be able to launch Zelrix in the first half of 2012, as it had expected.

NuPathe said it will ask for a meeting with the FDA to discuss its concerns.

Zelrix is a patch that delivers sumatriptan, the active ingredient in GlaxoSmithKline PLC’s migraine drug Imitrex. GlaxoSmithKline and several other companies sell tablet, nasal spray, and injectable forms of Imitrex.

Date: August 30, 2011
Source: Associated Press