Avanir (AMEX:AVN)
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From Jan 2020 to Jan 2025
AVANIR Pharmaceuticals (AMEX:AVN) announced that during
discussion with the U.S. Food and Drug Administration (FDA) yesterday
regarding AVANIR's new drug application (NDA) for Neurodex for the
treatment of pseudobulbar affect (PBA), the Agency requested that the
Company provide an expansion of certain summary analyses in its
application to better support the new electronic data submission
guidelines. The Company will be meeting with the Agency within the
next few weeks to discuss the requested analyses. Based on these
discussions, the Company expects that the FDA will reset the receipt
date of the NDA filing to coincide with the Company's submission of
this information.
"This delay is unfortunate, but we are very appreciative that the
FDA is willing to work closely with us to make our application as
complete and reviewable as possible," said Eric Brandt, President and
CEO of AVANIR.
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 disease. AVANIR has initiated
a Phase 3 clinical trial of Neurodex for the treatment of diabetic
neuropathic pain. AVANIR has active collaborations with two
international pharmaceutical companies, Novartis International
Pharmaceutical Ltd. for the treatment of inflammatory disease and
AstraZeneca UK Limited 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.