Avanir to Conduct Phase II Study on AVP-786 for Depression - Analyst Blog

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Pipeline updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.

Earlier this week, Avanir Pharmaceuticals, Inc. ( AVNR ) announced that its investigational new drug (IND) application for AVP-786 for a phase II study for the adjunctive treatment of major depressive disorder (MDD) has been accepted by the FDA. AVP-786 is Avanir's next generation compound.

Avanir intends to initiate a multi-center, randomized, double-blind, placebo-controlled proof-of-concept phase II study on AVP-786 in the third quarter of 2014. The study will evaluate the safety and efficacy of AVP-786 in MDD patients who respond inadequately to commonly prescribed antidepressants.


We note that, in Jun 2013, the FDA had decided to allow an expedited development path for AVP-786. For the development of AVP-786, Avanir might use the extensive data which was generated during AVP-923's development. On the basis of interim data, the company stated that AVP-786's safety and tolerability profile is comparable to AVP-923.

Currently, the acceptance of the IND application by the FDA has enabled the company to advance AVP-786 directly to the phase II study on MDD patients. Avanir has plans to study AVP-786 for a wide range of neurological and psychiatric indications including neuropathic pain, agitation in patients suffering from Alzheimer's disease and treatment resistant depression.

According to the press release issued by Avanir, approximately 16.1 million patients in the U.S. suffer from MDD in any particular year, with almost two-thirds of those diagnosed with the disease experiencing inadequate improvement following initial antidepressant therapy.

Meanwhile, Avanir is evaluating AVP-923 in two phase II studies − one for agitation in Alzheimer's disease and the other for levodopa-induced-dyskinesia in patients suffering from Parkinson's disease. Data readouts from both studies are expected by year end.

Avanir carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector are Salix Pharmaceuticals Ltd. ( SLXP ), The Medicines Company ( MDCO ) and Biogen Idec Inc. ( BIIB ). While Salix and The Medicines Company carry a Zacks Rank #1 (Strong Buy), Biogen carries 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 The NASDAQ OMX Group, Inc.




This article appears in: Investing , Business , Stocks

Referenced Stocks: IND , MDD , AVNR , MDCO , BIIB

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