AVANIR's Neurodex NDA Accepted with Priority Review for Involuntary Emotional Expression Disorder
04 Aprile 2006 - 2:00PM
Business Wire
AVANIR Pharmaceuticals (AMEX:AVN.R) announced today that the U.S.
Food and Drug Administration (FDA) has accepted for filing and
review its New Drug Application (NDA) for Neurodex(TM) for the
treatment of involuntary emotional expression disorder (IEED), also
known as pseudobulbar affect or emotional lability. In addition,
the Neurodex NDA will receive priority review by the FDA. The FDA
grants priority review status to products that, if approved, would
address an unmet medical need or are considered to be potentially
significant therapeutic advancements over existing approved
therapies in the treatment, diagnosis or prevention of a disease.
AVANIR completed the submission of its NDA to the FDA on January
27, 2006, and expects the FDA will take action on the NDA by July
30, 2006 (the "PDUFA date"). "We are very pleased that the FDA has
accepted for filing the NDA for Neurodex, and that our submission
will receive priority review," said Eric Brandt, AVANIR's President
and Chief Executive Officer. "With no currently approved treatments
for IEED, the agency's acceptance of our NDA represents an
important step forward in the potential care for those suffering
from IEED." 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 unpredictable and uncontrollable episodes of IEED that
occur as a consequence of neurological disease or injury. Two
controlled, multicenter Phase III clinical trials were conducted,
one in amyotrophic lateral sclerosis (ALS) patients with IEED, and
the other in multiple sclerosis (MS) patients with IEED. In the
clinical studies Neurodex achieved a statistically significant
reduction in the Center for Neurologic Study Lability Scale
(CNS-LS), a validated instrument that assesses frequency and
severity of IEED episodes, which was the primary efficacy endpoint
in both studies. Additionally, Neurodex achieved statistical
significance in all secondary endpoints, including reduction in
episodes of IEED. In these clinical trials, the most common adverse
events (AEs) associated with Neurodex were nausea, dizziness,
fatigue, diarrhea and headache. The majority of AEs reported were
mild or moderate, most occurring in the first week of treatment.
More patients on Neurodex discontinued due to adverse events than
patients in control groups. ABOUT INVOLUNTARY EMOTIONAL EXPRESSION
DISORDER Involuntary emotional expression disorder can occur when
disease or injury damages the area of the brain that controls
normal expression of emotion. This damage can disrupt brain
signaling, causing a "short circuit," triggering episodes of
involuntary emotional expressions. IEED episodes are often sudden,
unpredictable and contrary to the patient's mood. Patients who
experience unpredictable involuntary emotional displays are often
anxious and embarrassed by them, and avoid social situations, which
can result in isolation. It is hypothesized that neurological
diseases and traumatic brain injuries may lead to excessive
signaling via glutamate, an excitatory neurotransmitter, which can
manifest itself as IEED. Currently, there is no approved product
indicated for the treatment of IEED which occurs in patients with
neurological disorders, including ALS; MS; Parkinson's disease;
dementias, including Alzheimer's disease; and brain injuries such
as stroke and traumatic brain injury. ABOUT NEURODEX Neurodex is a
combination of two well-characterized compounds, the active
ingredient dextromethorphan, and the enzyme inhibitor quinidine,
which serves to increase the bioavailability of dextromethorphan.
The first-in-class drug candidate is believed to help regulate
excitatory neurotransmission in two ways, through presynaptic
inhibition of glutamate release via sigma-1 receptor agonist
activity, and through postsynaptic glutamate response modulation
via uncompetitive, low-affinity NMDA antagonist activity. ABOUT
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 diseases. AVANIR previously
announced positive results in the second of two required Phase III
clinical trials of Neurodex(TM), an investigational new drug for
the treatment of involuntary emotional expression disorder (IEED).
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.
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 Neurodex will receive regulatory
approval; or that 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