Avanir Pharmaceuticals, Inc. (AVNR) announced that the New Drug Application (:NDA) for its migraine candidate, AVP-825 has been accepted by the U.S. Food and Drug Administration (:FDA).
AVP-825 is being developed using OptiNose's novel Breath Powered intranasal delivery system, which includes low dosages of GlaxoSmithKline’s (GSK) Imitrex for the treatment of acute migraine.
The NDA was filed on the basis of data from a pivotal phase III trial and a phase II trial along with two pharmacokinetic studies on AVP-825. With the FDA accepting the NDA, a response regarding AVR-825 should be out by Nov 26, 2014.
We note that Avanir joined forces with OptiNose for the development and commercialization of AVP-825 for the treatment of acute migraine in 2013.
Avanir’s sole marketed product Nuedexta is approved for the treatment of patients suffering from pseudobulbar affect (:PBA). Net Nuedexta revenues for fiscal year 2013 (ended Sep 30, 2013) grew 90.7% year over year to $70.7 million. Avanir is looking to expand Nuedexta’s label. The company is evaluating Nuedexta for the treatment of agitation in Alzheimer's disease and for treating levodopa induced dyskinesia (:LID) in patients suffering from Parkinson's disease.
Avanir’s pipeline looks promising with candidates like AVP-825 and AVP-786. The approval of AVP-825 will reduce Avanir’s dependence on a solitary product. Once approved, AVP-825 will be the first and only fast-acting, dry-powder intranasal form of Imitrex.
Avanir currently carries a Zacks Rank #3 (Hold). Investors looking for better-ranked stocks in the biopharma sector may consider companies like Questcor Pharmaceuticals, Inc. (QCOR) and Alkermes (ALKS). Both stocks carry a Zacks Rank #1 (Strong Buy).