AVANIR Submits Expanded Neurodex New Drug Application for the Treatment of Involuntary Emotional Expression Disorder
30 Gennaio 2006 - 12:00PM
Business Wire
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.
Grafico Azioni Avanir (AMEX:AVN.R)
Storico
Da Mag 2024 a Giu 2024
Grafico Azioni Avanir (AMEX:AVN.R)
Storico
Da Giu 2023 a Giu 2024
Notizie in Tempo Reale relative a Avanir Pharmaceuticl (Borsa Americana (AMEX)): 0 articoli recenti
Più AVANIR Pharmaceuticals Articoli Notizie