Avanir Pharmaceuticals Announces Positive Interim Data From Pharmacokinetic
Study With Next Generation Compound AVP-786
ALISO VIEJO, Calif., Feb. 7, 2013
ALISO VIEJO, Calif., Feb. 7, 2013 /PRNewswire/ --Avanir Pharmaceuticals, Inc.
(NASDAQ: AVNR) announced today that it has successfully completed the first of
a two-stage pharmacokinetic study with AVP-786, a drug product containing a
deuterium modified form of dextromethorphan. Based on interim data, Avanir
believes that it has identified a formulation of AVP-786 with a comparable
pharmacokinetic, safety and tolerability profile to AVP-923 (dextromethorphan
hydrobromide and quinidine sulfate). The company has requested a meeting with
the FDA to discuss the full development path for AVP-786.
"The results of this study are very encouraging," said Joao Siffert, MD, chief
scientific officer for Avanir. "We were able to successfully replicate the
steady-state plasma levels of AVP-923, but with a substantially lower dose of
quinidine. Given these results, we believe that AVP-786 would be an ideal
candidate to test in one or more of our ongoing clinical programs."
Avanir also announced today that the company intends to modify the enrollment
target of its ongoing phase II clinical study of AVP-923 in central
neuropathic pain in multiple sclerosis to 200 patients.
"With the encouraging pharmacokinetic results in hand, we have made the
decision to accelerate the completion of the PRIME study, as we believe
AVP-786 has the potential to be a preferable development compound," said Joao
Siffert, MD. "We plan to use the data from the PRIME study to guide the
further development of AVP-786."
As a result of this change, the company now expects to have data from the
PRIME study in the fourth calendar quarter of 2013.
About the AVP-786 Phase I Study
The study design is a single-center, randomized, double-blind 2-way crossover
to assess the pharmacokinetic profile, safety, and tolerability of single and
multiple doses of AVP-786 (alone and in combination with low-dose quinidine).
AVP-923 was used as a control. The first stage of this study included 36
healthy subjects. Twelve additional subjects are currently enrolled in the
second stage of the study, which will explore a further reduction in
AVP-786 is a novel compound developed through incorporation of deuterium into
specific molecular positions of dextromethorphan. The compound maintains
similar pharmacology to that of dextromethorphan, but is less susceptible to
metabolism by the CYP2D6 enzyme. Avanir licensed exclusive worldwide rights
to AVP-786 from Concert Pharmaceuticals, Inc. AVP-786 is an investigational
drug not approved by the FDA.
AVP-923 is a combination of two well-characterized compounds, the active CNS
ingredient dextromethorphan hydrobromide (an uncompetitive NMDA receptor
antagonist and sigma-1 receptor agonist) plus low-dose quinidine sulfate (a
CYP2D6 enzyme inhibitor), which serves to increase the bioavailability of
dextromethorphan. AVP-923 is being studied in several ongoing clinical trials
including agitation in Alzheimer's disease, neuropathic pain in Multiple
Sclerosis, levodopa-induced dyskinesia in Parkinson's disease, and behavioral
symptoms of autism. AVP-923 is an investigational drug not approved by the
About the PRIME Study
The objectives of the PRIME (Pain Research In Multiple sclErosis) study are to
evaluate the safety, tolerability, and efficacy of AVP-923 for the treatment
of central neuropathic pain in patients with multiple sclerosis. The trial is
a multicenter, randomized, double-blind, placebo-controlled, 4-arm parallel
group study. Eligible patients will receive one of three dose levels of
AVP-923 containing either 45mg DM/10 mg Q, 30mg DM/10mg Q, 20mg DM/10mg Q or
placebo, daily for 12 weeks. The primary efficacy endpoint will be measured
based on the Numeric Pain Rating Scale as recorded in patient diaries.
Secondary assessments include measures of fatigue, impact of MS on daily life,
sleep quality, cognition and depression. Safety will be assessed by monitoring
adverse events, clinical laboratory tests, ECGs and physical examinations.
Avanir Pharmaceuticals, Inc. is a biopharmaceutical company focused on
bringing innovative medicines to patients with central nervous system
disorders of high unmet medical need. As part of our commitment, we have
extensively invested in our pipeline and are dedicated to advancing medicines
that can substantially improve the lives of patients and their loved ones.
For more information about Avanir, please visit www.avanir.com.
Avanir® is a trademark or registered trademark of Avanir Pharmaceuticals, Inc.
in the United States and other countries.
©2013 Avanir Pharmaceuticals, Inc. All Rights Reserved.
Forward Looking Statements
Except for the historical information contained herein, the matters set forth
in this press release, including statements regarding Avanir's plans,
potential opportunities, financial or other expectations, projections, goals
objectives, milestones, strategies, market growth, timelines, legal matters,
product pipeline, clinical studies, product development and the potential
benefits of its commercialized products and products under development are
forward-looking statements within the meaning of the "safe harbor" provisions
of the Private Securities Litigation Reform Act of 1995. These forward-looking
statements are subject to risks and uncertainties that may cause actual
results to differ materially, including the risks and uncertainties associated
with, the market demand for and acceptance of Avanir's products domestically
and internationally, research, development and commercialization of new
products domestically and internationally, including the risks and
uncertainties associated with meeting the objectives of the study of AVP-786,
and AVP-923, including, but not limited to, risks relating to the successful
development of these investigational drugs, delays or failures in enrollment,
obtaining additional indications for commercially marketed products
domestically and internationally, obtaining and maintaining regulatory
approvals domestically and internationally, and other risks detailed from time
to time in the Company's most recent Annual Report on Form 10-K and other
documents subsequently filed with or furnished to the Securities and Exchange
Commission. These forward-looking statements are based on current information
that may change and you are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date of this press
release. All forward-looking statements are qualified in their entirety by
this cautionary statement, and the Company undertakes no obligation to revise
or update any forward-looking statement to reflect events or circumstances
after the issuance of this press release.
Avanir Investor & Media Contact
Ian Clements, PhD
+1 (949) 389-6700
SOURCE Avanir Pharmaceuticals, Inc.
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