Message #12 From:
NewsBot Date: October 31, 2006 05:30:00 AM
AVNR News AVANIR Receives FDA Approvable Letter for Zenvia for the Treatment of Involuntary Emotional Expression Disorder
SAN DIEGO--(BUSINESS WIRE)--AVANIR Pharmaceuticals (NASDAQ:AVNR) announced that it has received an
approvable letter from the U.S. Food and Drug Administration (FDA) for
Zenvia™ (formerly referred to as Neurodex™)
for the treatment of involuntary emotional expression disorder (“IEED”).
The Company submitted a new drug application (“NDA”)
in January 2006, seeking to market Zenvia for the treatment of IEED in
patients with neurologic diseases and brain injuries. The communication
from the FDA indicates that AVANIR’s
application is approvable, subject to the FDA and AVANIR reaching
agreement on what additional safety and efficacy data will be required.
In accordance with FDA procedures, the Company anticipates scheduling a
meeting with the agency to discuss the approvable letter. Until the
Company is able to meet with the agency, it can not comment on the
specifics of the approvable requirements. Additionally, the Company
cannot be certain that once it has met with the FDA, that it will choose
to continue with the development of Zenvia as previously planned.
“We will be working closely with the agency to
determine the next steps required for the drug to receive marketing
approval,” said Eric K. Brandt, President and
Chief Executive Officer of AVANIR. “We believe
Zenvia can significantly improve the lives of patients, their families
and their caregivers by reducing the emotional and social toll taken by
IEED.”
About AVANIR
AVANIR Pharmaceuticals is focused on developing, acquiring and
commercializing novel therapeutic products for the treatment of chronic
diseases. AVANIR’s products and product
candidates address therapeutic markets that include the central nervous
system, cardiovascular disorders, inflammation and infectious diseases.
AVANIR currently markets FazaClo®,
the only orally-disintegrating formulation of clozapine for the
management of severely ill schizophrenic patients who fail to respond
adequately to standard schizophrenic drug treatments. FazaClo is also
indicated for reducing the risk of suicidal behavior in patients with
schizophrenic or schizoaffective disorder. For full prescribing
information and important safety information regarding FazaClo, please
visit www.fazaclo.com. Zenvia™,
AVANIR's lead product candidate, is under development for the treatment
of involuntary emotional expression disorder. Additionally, AVANIR has
initiated a Phase III clinical trial with Zenvia as a potential
treatment for patients with painful diabetic neuropathy. AVANIR has
active collaborations with two international pharmaceutical companies:
Novartis International Pharmaceutical Ltd. for the treatment of
inflammatory disease and AstraZeneca for the treatment of cardiovascular
disease. The Company's first commercialized product, abreva®,
is marketed in North America by GlaxoSmithKline Consumer Healthcare and
is the leading over-the-counter product for the treatment of cold sores.
Further information about AVANIR can be found at www.avanir.com.
Forward-Looking Statement
Statements in this press release that are not historical facts,
including statements that are preceded by, followed by, or that include
such words as "estimate," "anticipate," "believe," "plan," or "expect,"
or similar statements, are forward-looking statements that are subject
to certain risks and uncertainties that could cause actual results to
differ materially from the future results expressed or implied by such
statements. There can be no assurance that the Company will continue the
clinical development of Zenvia after meeting with the FDA or that Zenvia
will receive final FDA regulatory approval. If such regulatory approval
is received, there can be no assurance that AVANIR will be able to
market Zenvia successfully. Final review decisions made by the FDA and
other regulatory agencies concerning clinical trial results are often
unpredictable and outside the influence and/or control of the Company.
Risks and uncertainties also include the risks set forth in AVANIR's
most recent Annual Report on Form 10-K and subsequent Quarterly Reports
on Form 10-Q and from time-to-time in other publicly available
information regarding the Company. Copies of this information are
available from AVANIR upon request. AVANIR disclaims any intent or
obligation to update these forward-looking statements.
