Saturday, October 29, 2011
Zelrix Migraine Patch
You may want to read about the FDA Approval process of the Zelrix Migraine Patch in a post Diana Lee put together on Migraine.Com. She explains how the FDA “looks for weaknesses in the manufacturer’s data and decides whether it agrees with the conclusions made in the application. The agency’s goal is to review and act on at least 90% of drug applications within 10 months of being filed. If the team decides the drug’s benefits outweigh its risks, they will approve it. Sometimes the FDA team will ask for additional information to help in making their decision.”
I know there have been times I couldn’t take an oral triptan because of extreme nausea and I couldn’t use a nasal spray triptan because of congestion or the feeling that it would make my nausea worse and my doctor does not believe in the injectable triptans because many patients find them hard to use so I would find myself without a way to abort my Migraine.
the Zelrix Patch on the NuPathe site. “Zelrix, is an active, single-use transdermal sumatriptan patch that we are developing for the treatment of acute migraine. Zelrix utilizes SmartRelief, our proprietary transdermal delivery technology. SmartRelief consists of a controlled delivery technology that uses a mild electrical current to actively deliver medication through the skin in a process called iontophoresis. Zelrix was designed to overcome several of the key limitations associated with current migraine treatments.”
I feel that the Zelrix patch fills a big void in the Migraine marketplace. It’s definitely something I want to try especially on those days I have no other alternative way to take a triptan. I’m sure the FDA is over worked and under a lot of pressure to review many of the applications they receive, but I’m not sure they understand the need for more Migraine products.
So what have I done about this?
I sent an email to Russell Katz, MD the Division Director of Neurology Products at the FDA. Teri Robert wrote about the letter she sent in her post about the FDA Approval of Zelrix Migraine Patch Delayed . As Teri said, “emails from consumers (that’s us!) can’t hurt at this point and could help with the approval of Zelrix. If you’d like to send him an email, his email address is firstname.lastname@example.org.”
If you would like to send one too, you will need to hurry as I believe the FDA and NuPathe are expected to meet again on November 9th so emails would have to be sent before then.
We need to start helping ourselves and fellow Migraineurs when it comes to our Migraines. What are you going to do now?