Avanir Pharmaceuticals Announces Positive Interim Data From Pharmacokinetic Study With Next Generation Compound AVP-786
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.
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"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 quinidine.
About AVP-786
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.
About AVP-923
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 FDA.
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.
About Avanir
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
ir@avanir.com
+1 (949) 389-6700
SOURCE Avanir Pharmaceuticals, Inc.
Web Site: www.avanir.com
Posted: February 2013
