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.
) 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
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.
The Medicines Company
Biogen Idec Inc.
). While Salix and The Medicines Company carry a Zacks Rank #1
(Strong Buy), Biogen carries a Zacks Rank #2 (Buy).
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