XenoPort and the NIAAA Announce Clinical Trial Agreement to Study HORIZANT as a Potential Treatment for Alcohol Use Disorder
September 09 2014 - 8:30AM
Business Wire
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
XenoPort, Inc.Jackie Cossmon, 408-616-7220ir@XenoPort.com
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