OptiNose for Migraine: Not Approved Yet
Last month the FDA announced that they would not (yet) approve a new migraine nasal spray, known as AVP-825 from OptiNose.
We’ve talked about this new delivery system for sumatriptan in the past (see OptiNose: In Search of a Better Nasal Spray). AVP-825 is a unique delivery system that delivers the medication (sumatriptan powder) quickly an effectively. For reasons of economy and health, it’s important to get all of the medication where it needs to go in your body as soon as possible.
The phase III trials demonstrated that the medication and delivery system work, providing relief as early as 15-30 minutes after use, with most patients finding relief and nearly 20% completely free of migraine symptoms at 1 hour.
So what was the problem? Why did the FDA reject the medication?
“Human factors”. In other words, is the treatment easy enough to use so that us humans won’t mess it up.
Hopefully this will be a simple question to answer. Avanir Pharmaceuticals Inc. will be conducting a new trial with real humans, and hopes to respond to the FDA before the middle of next year.
For more information:
- FDA Declines Approval for Intranasal Migraine Treatment
- A Randomized, Double-Blind, Placebo-Controlled Study of Breath Powered Nasal Delivery of Sumatriptan Powder (AVP-825) in the Treatment of Acute Migraine (The TARGET Study)
- OptiNose Announces Publication of Pivotal Phase III Results
- OptiNose website