Wednesday, August 31, 2011

Migraine Drug Zelrix Not Approved in FDA Vote


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As I told you on Monday, the FDA voted on whether to approve NuPathe Pharmaceuticals' single-use sumatriptan migraine patch medication Zelrix on that same day. Unfortunately, the drug was not approved because the agency requires more information to make its decision. (You can learn more about the FDA approval process at this Migraine.com blog post I wrote: Zelrix Sumatriptan Patch & FDA Approval Process.)

In its complete response letter asking for more information from NuPathe, the FDA said the company has demonstrated the efficacy of the product. However, there are questions and concerns about other issues related to safety, chemistry and manufacturing.

In a press release NuPathe CEO Jane Hollingworth (FYI, she's a fellow migraineur) says the company believes it already has the information necessary to address the FDA's questions and concerns. Unfortunately NuPathe will no longer be able to launch Zelrix in the first half of 2012, as planned, but hopefully the product will be brought to market at some point because I think it holds great potential for migraine patients.

You can learn more about NuPathe's migraine-related nausea education efforts (and enter a contest to win an iPad 2!) at this link: Migraine-Related Nausea.

You can read more about Zelrix and the migraine-related issues it has been designed to address in these posts:

FDA to Vote on Zelrix Migraine Drug Approval
Why Are Pills Hard for Migraineurs to Use?
Migraine Medications 101: Triptans
Details of Sumatriptan Migraine Patch to be Released at IHS Meeting
Zelrix Transmits Sumatriptan Through Skin Patch


Sources:
FDA Requests More Study of Migraine Patch
FDA Requests Additional Information Regarding NuPathe's Migraine Patch in Complete Response Letter

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DISCLAIMER: Nothing on this site constitutes medical or legal advice. I am a patient who is engaged and educated and enjoys sharing my experiences and news about migraines, pain and depression. Please consult your own health care providers for advice on your unique situation.