XenoPort, Inc. (Nasdaq:XNPT) and the National Institute on Alcohol Abuse
and Alcoholism (NIAAA) announced today that the NIAAA has initiated a
clinical trial of HORIZANT® (gabapentin enacarbil)
Extended-Release Tablets as a potential treatment for alcohol use
disorder (AUD).
“This multi-site, well-controlled clinical trial will allow us to
evaluate the safety and effectiveness of gabapentin enacarbil in
treating AUD,” said George F. Koob, Ph.D., director of the NIAAA.
“Gabapentin has shown promising results in earlier clinical trials, and
the development of new medications is an important component of our
commitment to broaden the range of treatment options for people with
AUD.”
The NIAAA plans to enroll approximately 350 subjects in a randomized,
double-blind, placebo-controlled clinical trial of HORIZANT in patients
with AUD at approximately 10 sites in the United States. The study will
assess the efficacy of 1200 mg of HORIZANT (administered in two daily
doses of 600 mg each) compared with placebo to reduce drinking in
subjects who report four or more symptoms of AUD, as defined in the
Diagnostic and Statistical Manual of Mental Disorders – Fifth Edition
(DSM-5). Eligible subjects will receive either HORIZANT or placebo for
26 weeks, to include one-week escalation, 24-week maintenance and
one-week taper periods. The primary objective of the study is to compare
the efficacy of HORIZANT with matched placebo on the primary alcohol
consumption outcome, which is percentage of subjects with no heavy
drinking days during the last four weeks of the treatment.
Ronald W. Barrett, Ph.D., XenoPort’s chief executive officer, stated,
“We are happy to be working with the NIAAA on this important clinical
trial. We believe that the differentiated pharmacokinetic features of
HORIZANT make it particularly well-suited for testing in this patient
population. Our prior joint discussions with the U.S. Food and Drug
Administration have indicated that positive results from this study,
along with other supporting data, could enable us to move forward
rapidly to file a supplemental New Drug Application for HORIZANT as a
potential treatment for AUD. We believe patients with AUD are seriously
underserved by current FDA-approved treatments.”
About Alcohol Use Disorder (AUD)
AUDs are medical conditions that doctors diagnose when a patient’s
drinking causes distress or harm. The fourth edition of the Diagnostic
and Statistical Manual (DSM–IV), published by the American Psychiatric
Association, described two distinct disorders—alcohol abuse and alcohol
dependence—with specific criteria for each. The fifth edition, DSM–5,
integrates the two DSM–IV disorders, alcohol abuse and alcohol
dependence, into a single disorder called alcohol use disorder, or AUD,
with mild, moderate, and severe subclassifications.
According to the 2013 National Survey on Drug Use and Health, 16.6
million adults ages 18 and older, or approximately 7.0 percent of this
age group, had an AUD in 2013. About 1.3 million adults received
treatment for an AUD at a specialized facility in 2013, representing
less than 10 percent of adults who needed treatment for AUD.
About HORIZANT
Discovered and developed by XenoPort, HORIZANT (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.
For further information about the NIAAA clinical trial of HORIZANT in
patients with AUD, please go to www.ClinicalTrials.gov
or click the link below:
https://www.clinicaltrials.gov/ct2/show/NCT02252536?term=NIAAA+and+gabapentin+enacarbil&rank=1
Background of Gabapentin in AUD Clinical Studies
Data from previously completed 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 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® (gabapentin enacarbil)
Extended-Release Tablets 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
potentially for relapsing forms of multiple sclerosis. REGNITE®
(gabapentin enacarbil) Extended-Release Tablets is being marketed in
Japan by Astellas Pharma Inc. XenoPort has entered into a collaboration
with the NIAAA for the potential development of HORIZANT as a treatment
for AUD and has granted exclusive world-wide rights for the development
and commercialization of its clinical-stage oral product candidate,
arbaclofen placarbil, to Indivior PLC for all indications. XenoPort's
pipeline of product candidates also includes a potential treatment for
patients with idiopathic 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; future regulatory discussions and the timing
thereof; the possibility of utilizing the proposed study as the basis
for an sNDA filing for HORIZANT for patients with AUD; the expected
study design and enrollment in the clinical trial of gabapentin
enacarbil, and the timing thereof; 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,” “could,”
“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 March 31, 2015 filed
with the Securities and Exchange Commission on May 7, 2015. 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
View source version on businesswire.com: http://www.businesswire.com/news/home/20150625005411/en/
Copyright Business Wire 2015