Avanir Pharmaceuticals, Inc. (AVNR) announced that it finished enrolling patients in a phase II label expansion study on AVP-923. This double blind, placebo controlled proof-of-concept study (n=220) is evaluating the safety, tolerability, and efficacy of AVP-923 for the treatment of patients suffering from agitation due to Alzheimer's disease.
Top-line results should be out by late September or early October.
We note that AVP-923 is already approved in the U.S. and the EU under the trade name Nuedexta for the treatment of pseudobulbar affect (PBA). Nuedexta gross sales were $55.7 million in the first six months of fiscal 2014. The Nuedexta franchise continues to grow as indicated by the increasing number of prescriptions from the year-ago quarter.
Avanir is conducting another phase II study on AVP-923 for levodopa induced dyskinesia (:LID) in patients suffering from Parkinson's disease.
Meanwhile, the company is working on strengthening its pipeline. Avanir is developing AVP-786 for managing neuropsychiatric manifestations of neurological disease, including agitation. The company plans to submit an investigational new drug (IND) application for AVP-786, after which it will initiate a phase II study on 786 in treatment-resistant patients suffering from major depressive disorder. Avanir said that results from the phase II study on AVP-923 will guide the developments for a phase III study on AVP-786.
Additionally, a response from the U.S. Food and Drug Administration (:FDA) for the new drug application (:NDA) for AVP-825 (acute migraine) should be out by Nov 26. On approval, the company intends to launch AVP-825 in the first half of 2015.
Avanir carries a Zacks Rank #2 (Buy). Some better-ranked stocks in the health care sector include Grifols, S.A. (GRFS), ARIAD Pharmaceuticals Inc. (ARIA) and Astellas Pharma, Inc. (ALPMY). While Grifols carries a Zacks Rank #1 (Strong Buy), ARIAD and Astellas hold a Zacks Rank #2 (Buy).
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