Patients Enrolled in Avanir Study - Analyst Blog

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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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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