Avanir Pharmaceuticals, Inc.
) 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
Avanir is conducting another phase II study on AVP-923 for levodopa
induced dyskinesia (LID) in patients suffering from Parkinson's
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
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
ARIAD Pharmaceuticals Inc.
Astellas Pharma, Inc.
). While Grifols carries a Zacks Rank #1 (Strong Buy), ARIAD and
Astellas hold a Zacks Rank #2 (Buy).
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