Avanir Pharmaceuticals, Inc.
) shares were up 4.13% following the company's announcement that it
finished enrolling patients in a phase II label expansion study on
AVP-923. Overall shares increased 9.1% since the announcement.
The 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). Other stocks looking good in
the health care sector are
ARIAD Pharmaceuticals Inc.
Astellas Pharma, Inc.
). All these stocks carry a Zacks Rank #2.
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