Avanir Pharmaceuticals, Inc.
) recently held a pre-IND (Investigational New Drug) meeting with
the US Food and Drug Administration (FDA) for its next-generation
candidate, AVP-786. Following interactions with the FDA, an
agreement was reached for a faster development path for Avanir's
AVP-786, which contains deuterium-modified dextromethorphan
and quinidine, is being developed for the treatment of neurologic
and psychiatric disorders.
Under the agreement with the FDA, Avanir will be allowed to
use the data generated on Nuedexta (AVP-923) to support the IND
application as well as regulatory filings for AVP-786 in the US.
This will not only help fasten the development process for
AVP-786, it will also lower development-related costs.
We note that Nuedexta is approved in the US for the treatment
of pseudobulbar affect and is under review in the EU.
In Feb 2013, Avanir had completed the first of a two-stage
pharmacokinetic study with AVP-786. The study evaluated the
candidate's pharmacokinetics across single and multiple doses.
The study identified a formulation of AVP-786 with a comparable
pharmacokinetic, safety and tolerability profile to Nuedexta.
AVP-786 contains quinidine at a lower dosage than that used in
Avanir intends to integrate AVP-786 into its ongoing programs
on Nuedexta. Nuedexta is being studied for three additional
indications, namely, agitation in Alzheimer's disease (phase II
ongoing), central neuropathic pain in multiple sclerosis (phase
II ongoing) and levodopa-induced-dyskinesia in Parkinson's
disease (enrollment for phase II about to begin).
Avanir plans to accelerate the PRIME study (neuropathic pain
related to multiple sclerosis) being conducted with Nuedexta.
Top-line data from the study is expected in the fourth quarter of
Avanir currently carries a Zacks Rank #3 (Hold). Currently,
Salix Pharmaceuticals Ltd.
) look well positioned with a Zacks Rank #1 (Strong Buy).
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