XenoPort, Inc. (Nasdaq:XNPT) and the National Institute on Alcohol Abuse
and Alcoholism (NIAAA) announced today that they have entered into an
agreement to conduct a clinical trial of HORIZANT®
(gabapentin enacarbil) Extended-Release Tablets as a potential treatment
for alcohol use disorder (AUD). Under the terms of the agreement,
XenoPort will supply clinical trial material and the NIAAA will conduct
and pay all other expenses associated with the proposed clinical trial
of HORIZANT. XenoPort will have access to study results generated under
the proposed clinical trial to support potential regulatory filings for
HORIZANT.
“Current medications for alcohol dependence are effective for some, but
not all, patients. New medications are needed to provide effective
therapy to a broader spectrum of alcohol dependent individuals,” said
George F. Koob, Ph.D., director of the NIAAA, a part of the National
Institutes of Health. “Prior clinical studies of gabapentin, the active
metabolite of the molecule called gabapentin enacarbil, have shown
positive results in patients with AUD. We believe that the time is right
to conduct a multi-site, well-controlled clinical trial.”
The study is planned to be a randomized, double-blind,
placebo-controlled clinical trial of the safety and efficacy of HORIZANT
in patients who have AUD but are abstinent at treatment initiation. The
study is expected to have a treatment period of six months and to enroll
approximately 350 patients beginning in the first half of 2015.
XenoPort and the NIAAA are planning to meet with the U.S. Food and Drug
Administration (FDA) Division of Anesthesia, Analgesia and Addiction
Products in the fourth quarter of 2014 to discuss the trial design and
the possibility of utilizing the results of this trial as the basis for
a potential supplemental new drug application (sNDA) submission for
HORIZANT for the maintenance of abstinence from heavy drinking of
alcohol in patients with AUD.
Ronald W. Barrett, Ph.D., chief executive officer of XenoPort, Inc.,
stated, “Our goal in designing gabapentin enacarbil was to address the
pharmacokinetic limitations of gabapentin. We are hopeful that the
predictable high bioavailability, rapid titration and low fluctuating
gabapentin blood levels with twice-daily administration associated with
HORIZANT may enable successful treatment of AUD and look forward to
working with the NIAAA on this important study.”
Background of Gabapentin in AUD Clinical Studies
Data from clinical trials indicate that oral gabapentin may reduce
alcohol craving and alcohol withdrawal symptoms. In addition,
single-site clinical trials have also shown that in alcohol dependent
patients who are abstinent at treatment initiation, gabapentin delayed
the onset to heavy drinking and improved the symptoms of insomnia. In
these studies, gabapentin was generally well-tolerated.
About HORIZANT
Discovered and developed by XenoPort, gabapentin enacarbil is a prodrug
of gabapentin. In the United States, XenoPort has six issued patents
listed in the FDA’s Orange Book for HORIZANT that have expiration dates
between 2022 and 2029.
About Alcohol Use Disorder (AUD)
AUD affects about 17 million people in the United States and has an
estimated societal cost of approximately $225 billion each year,
primarily from lost productivity, but also from healthcare and property
damage costs.
About XenoPort
XenoPort, Inc. is a biopharmaceutical company focused on developing and
commercializing a portfolio of internally discovered product candidates
for the potential treatment of neurological disorders. XenoPort is
currently commercializing HORIZANT in the United States and developing
its novel fumaric acid ester product candidate, XP23829, as a potential
treatment for patients with moderate-to-severe chronic plaque-type
psoriasis and/or relapsing forms of multiple sclerosis. REGNITE®
(gabapentin enacarbil) Extended-Release Tablets is being marketed in
Japan by Astellas Pharma Inc. XenoPort recently granted exclusive
world-wide rights for the development and commercialization of its
clinical-stage oral product candidate, arbaclofen placarbil, to Reckitt
Benckiser Pharmaceuticals, Inc. for all indications. XenoPort's pipeline
of product candidates also includes a potential treatment for patients
with Parkinson's disease.
To learn more about XenoPort, please visit the website at www.XenoPort.com.
Forward-Looking Statements
This press release contains “forward-looking” statements, including,
without limitation, all statements related to the potential clinical
development of HORIZANT; the suitability of gabapentin enacarbil as a
potential treatment of AUD; planned regulatory discussions and the
timing thereof; the possibility of utilizing the proposed study as the
basis for an sNDA filing for HORIZANT for the maintenance of abstinence
from alcohol in patients with alcohol dependence; the expected study
design and enrollment in the proposed clinical trial of gabapentin
enacarbil, and the timing thereof; XenoPort’s expectation that top-line
results of the proposed clinical trial of gabapentin enacarbil would be
available in the second half of 2016; and the therapeutic and commercial
potential of gabapentin enacarbil. Any statements contained in this
press release that are not statements of historical fact may be deemed
to be forward-looking statements. Words such as “believe,” “expected,”
“goal,” “hopeful,” “may,” “planning,” “possibility,” “potential,”
“proposed,” “will” and similar expressions are intended to identify
forward-looking statements. These forward-looking statements are based
upon XenoPort's current expectations. Forward-looking statements involve
risks and uncertainties. XenoPort's actual results and the timing of
events could differ materially from those anticipated in such
forward-looking statements as a result of these risks and uncertainties,
which include, without limitation, the difficulty and uncertainty of
pharmaceutical product development and the uncertain results and timing
of clinical trials and other studies, including the risk that success in
preclinical testing and early clinical trials do not ensure that later
clinical trials will be successful, and that the results of clinical
trials by other parties may not be indicative of the results in trials
that XenoPort or its partners may conduct; XenoPort’s and the NIAAA’s
ability to successfully advance gabapentin enacarbil development and to
conduct clinical trials in the anticipated timeframes, or at all; the
risk that the completion of clinical trials for gabapentin enacarbil may
be delayed or terminated as a result of many factors, including delays
in patient enrollment; that gabapentin enacarbil may require significant
additional clinical testing prior to any possible additional regulatory
approvals; the uncertainty of the FDA’s review process and other
regulatory requirements; the uncertainty of protecting and expanding
XenoPort’s intellectual property rights, including the risk that patent
rights may not provide XenoPort with sufficient protection against
competitive products or otherwise cover commercially valuable products
or processes; XenoPort’s dependence on collaborative partners; and the
uncertain therapeutic and commercial value of XenoPort’s product
candidates. These and other risk factors are discussed under the
heading “Risk Factors” in XenoPort’s Quarterly Report on Form 10-Q for
the quarter ended June 30, 2014 filed with the Securities and Exchange
Commission on August 7, 2014. XenoPort expressly disclaims any
obligation or undertaking to release publicly any updates or revisions
to any forward-looking statements contained herein to reflect any change
in the company's expectations with regard thereto or any change in
events, conditions or circumstances on which any such statements are
based.
HORIZANT, REGNITE and XENOPORT are registered trademarks of XenoPort,
Inc.
Source code: XNPT2C
Copyright Business Wire 2014