Avanir Pharmaceuticals, Inc. (AVNR) received a preliminary feedback from the FDA regarding the company’s new drug application for its Breath Powered intranasal delivery system, AVP-825. The company is looking to get AVP-825 approved for the treatment of migraine.

In its feedback, the FDA requested Avanir to conduct additional human factor testing on AVP-825. With the review under progress, the FDA may provide additional comments regarding the application.

Based on these developments, Avanir stated that the approval of AVP-825 will be delayed (previously expected by Nov 26, 2014).

Avanir said that it will work with the FDA to meet the agency’s requirements. Avanir had licensed AVP-825 from OptiNose AS in Jul 2013.

Our Take

The FDA’s preliminary feedback on AVP-825 is a setback for the company. Had it been approved, AVP-825 would have been the first and only fast-acting, dry-powder intranasal form of GlaxoSmithKline’s (GSK) Imitrex (sumatriptan) for the treatment of migraine. Moreover, approval would have boosted the top-line since currently Avanir depends solely on Nuedexta for growth.

Meanwhile, Avanir is developing AVP-786 for the treatment of neurologic and psychiatric disorders. Currently, AVP-786 is in a phase II study as an adjunctive therapy for major depressive disorder. Avanir is also developing AVP-923 for the treatment of levodopa-induced dyskinesia in Parkinson’s disease. Proof-of-concept data from this study is expected by year end.

Avanir currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Auxilium Pharmaceuticals Inc. (AUXL) and Lannett Company, Inc. (LCI). Both carry a Zacks Rank #1 (Strong Buy).

(We are reissuing this article to correct a mistake. The original article, issued on Nov 10, 2014, should no longer be relied upon.)

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