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Avanir Doses First Patient with AVP-786, Updates on AVP-923

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Avanir Pharmaceuticals, Inc. (AVNR) announced that it has enrolled the first patient in a phase II study on AVP-786 for the adjunctive treatment of major depressive disorder (MDD). The company also provided an update on a phase II study on AVP-923 for agitation in Alzheimer's disease patients.

The 10-week, multi-center, randomized, double-blind, placebo-controlled proof-of-concept phase II study on AVP-786  will evaluate its efficacy and safety in MDD patients who respond inadequately to commonly prescribed antidepressants, including selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs).

Late last month, in a press release issued by Avanir, the company said that it might use the extensive data generated during the development of AVP-923 (another central nervous system candidate at Avanir), for the development of AVP-786, the next-generation AVP-923 compound. AVP-786 is under an expedited development path following the FDA’s decision on the same.

We note that Avanir has plans to study AVP-786 for a wide range of neurological and psychiatric indications including neuropathic pain and agitation in patients suffering from Alzheimer’s disease.

According to the press release issued by Avanir, approximately 16 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.

Additionally, Avanir announced that results from a phase II study on AVP-923 are expected in the late September − early October timeframe. The 10-week, multi-center, randomized, double-blind, placebo-controlled proof-of-concept study is evaluating the safety, tolerability and efficacy of AVP-923 for the treatment of agitation in patients with Alzheimer’s disease.

AVP-923 is also in a phase II study for the treatment of levodopa-induced dyskinesia in Parkinson’s disease.

Our Take

We are pleased with Avanir’s efforts to develop its pipeline. The company, which depends highly on Nuedexta for revenue growth, has an important data readout scheduled later this year. Meanwhile, we expect investor focus to remain on AVP-923 data read-outs.

Avanir carries a Zacks Rank #2 (Buy). Some better-ranked stocks in the health care sector include Endo International plc (ENDP), Hyperion Therapeutics, Inc. (HPTX) and United Therapeutics Corporation (UTHR). All these stocks carry a Zacks Rank #1 (Strong Buy).

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