Avanir Pharmaceuticals ($AVNR), awaiting FDA approval for a new migraine treatment, got a letter from the agency pointing out flaws in submitted data, a regulatory hiccup that could derail the company's plans.
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| Avanir's and OptiNose's powder delivery devices with nosepiece and mouthpiece--Courtesy of OptiNose |
The product is AVP-825, or OptiNose, a drug-device combo that delivers a nasal burst of low-dose sumatriptan to treat migraines. The FDA is in the midst of reviewing Avanir's treatment and broke its silence to inform the company of some deficiencies in its application, the company said. The agency's problem stems from Avanir's so-called human factor validation study, designed to explore whether patients can safely and effectively use the delivery device, and the FDA wants the company to conduct another test.
That's hardly an outright rejection for AVP-825, but, as Avanir points out, it's now unlikely the drug will be approved by Nov. 26, which was the FDA's target date.
"We plan to work closely with the FDA to answer the agency's questions and satisfy their requirements," Avanir Chief Medical Officer Joao Siffert said in a statement. "We remain confident that AVP-825 will be an important new treatment option for migraine patients who are in need of alternative, fast acting and well-tolerated medications."
However, beyond the short-run delay, the FDA's issue could be a long-term blow to the treatment's approvability. The delivery device is AVP-825's principal value proposition, as the long-generic sumatriptan is already well-understood, so any serious concerns about use-related risks or technological failures could block its path to the market.
Avanir bought into the treatment last year in a deal worth up to $110 million, wooed by Phase III data in which a dose of AVP-825 relieved migraine symptoms for 42% of patients in 30 minutes with 68% pain-free within two hours.
- read the statement