Avanir (AMEX:AVN.R)
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From May 2019 to May 2024
AVANIR Pharmaceuticals (AMEX:AVN.R) announced today that
on Friday, January 27, 2006, it completed the submission of its new
drug application (NDA) to the U.S. Food and Drug Administration (FDA)
for Neurodex(TM), seeking marketing approval of the drug candidate for
the treatment of involuntary emotional expression disorder, also known
as pseudobulbar affect or emotional lability. The application was
resubmitted to the FDA to provide an expansion of certain summary
analyses which better support the electronic common technical document
(e-CTD) format.
The application is based on clinical data supporting that
Neurodex, a combination of dextromethorphan and low dose quinidine, is
safe and effective in reducing the frequency and severity of sudden
and uncontrollable crying and/or laughing episodes that occur as a
consequence of neurological disease or injury. AVANIR has formally
requested priority review status from the FDA for this application. If
the FDA grants AVANIR's priority review request, the date for the
agency to take action on the application will be six months from the
filing date. If standard review status is granted, a review time of
ten months will apply to the application.
"We are very pleased to announce this important submission. While
the FDA's request was limited to reorganization and expanded
discussions of existing data within the electronic document, we took
the time to include additional safety data rather than providing it as
a separate supplemental filing as originally planned. The additional
safety data are consistent with the data previously submitted," said
Eric K. Brandt, President and Chief Executive Officer of AVANIR. "We
feel the application is strengthened, and look forward to hearing from
the FDA over the next sixty days regarding the fileability status and
the review designation granted for our application."
AVANIR Pharmaceuticals is focused on developing and
commercializing novel therapeutic products for the treatment of
chronic diseases. AVANIR's product candidates address therapeutic
markets that include central nervous system and cardiovascular
disorders, inflammation, and infectious diseases. AVANIR previously
announced positive results in the second of two required Phase III
clinical trials of Neurodex, an investigational new drug for the
treatment of involuntary emotional expression disorder. Additionally,
AVANIR has initiated a Phase III clinical trial for Neurodex as a
potential treatment in patients with diabetic neuropathic pain, a
second indication for Neurodex. 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(R)," 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.
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 AVANIR's
new drug application for Neurodex(TM) will be accepted for filing by
the FDA within the anticipated time period or at all; that Neurodex
will receive regulatory approval; or that even if such regulatory
approval is received, AVANIR will be able to market Neurodex
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.