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
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version on businesswire.com: http://www.businesswire.com/news/home/20150625005411/en/
XenoPort, Inc.Jackie Cossmon, 408-616-7220ir@XenoPort.com
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