XenoPort, Inc. (Nasdaq: XNPT) announced today that pooled data analyses
for HORIZANT® (gabapentin enacarbil) Extended-Release
Tablets, will be presented at the upcoming 29th Associated
Professional Sleep Societies (APSS) annual SLEEP meeting in Seattle. The
presentations include:
-
Association Between Pain and Symptoms of Restless Legs Syndrome (RLS)
in Adults With Moderate-to-Severe Primary RLS in a Combined Treatment
Population: Pooled Analyses From 3 Randomized Controlled Trials
Poster
#253, Wednesday, June 10, 10:20 am – 12:20 pm PDT, Exhibit Hall 4AB.
-
The Effect of Gabapentin Enacarbil on Pain Outcomes and Restless Legs
Syndrome Symptoms in Adults With Moderate-to-Severe Primary RLS:
Pooled Analyses From 3 Randomized, Controlled Trials
Poster #256,
Wednesday, June 10, 10:20 am – 12:20 pm PDT, Exhibit Hall 4AB.
About HORIZANT
HORIZANT, discovered and developed by XenoPort, was approved in the
United States in April 2011 for the treatment of moderate-to-severe
primary restless legs syndrome (RLS) in adults and in June 2012 for the
management of postherpetic neuralgia (PHN) in adults. The most common
adverse reactions for adult patients with moderate-to-severe primary RLS
receiving HORIZANT were somnolence/sedation, dizziness, headache, nausea
and fatigue. The most common adverse reactions for adult patients with
PHN taking HORIZANT were dizziness, somnolence/sedation, headache,
nausea and fatigue.
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 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 clinical trial agreement with the National Institute on Alcohol
Abuse and Alcoholism (NIAAA) under which the NIAAA plans to conduct a
clinical trial evaluating gabapentin enacarbil as a potential treatment
for alcohol use disorder, and XenoPort 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 Web site at www.XenoPort.com.
HORIZANT (gabapentin enacarbil) Extended-Release Tablets
INDICATIONS
HORIZANT (gabapentin enacarbil) is a prescription
medicine used to:
-
treat adults with moderate-to-severe primary Restless Legs Syndrome
(RLS). HORIZANT is not for people who need to sleep during the daytime
and stay awake at night.
-
manage pain from damaged nerves (postherpetic neuralgia) that follows
healing of shingles (a painful rash that comes after a herpes zoster
infection) in adults.
IMPORTANT SAFETY INFORMATION
-
Do not drive after taking your dose of HORIZANT until
you know how it affects you, including the morning after you take it. Do
not operate heavy machinery or do other dangerous activities until
you know how HORIZANT affects you. HORIZANT can cause sleepiness,
dizziness, slow thinking, and can affect your coordination. Ask your
healthcare provider when it is okay to do these activities.
-
Do not take other medicines that make you sleepy or dizzy while taking
HORIZANT without talking to your healthcare provider. Taking HORIZANT
with these other medicines may make your sleepiness or dizziness worse.
-
HORIZANT may cause suicidal thoughts or actions in a very small
number of people (about 1 in 500). Pay attention to any changes,
especially sudden changes, in mood, behaviors, thoughts, or feelings.
Call your healthcare provider right away if you have any of these
symptoms, especially if they are new, worse, or worry you:
-
thoughts or actions about suicide, self-harm, or dying; attempt to
commit suicide
-
new or worsening depression or anxiety; or feeling agitated
-
new or worse restlessness or panic attacks
-
new or worse trouble sleeping (insomnia); or irritability
-
acting aggressive, being angry, or violent; acting on dangerous
impulses
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an extreme increase in activity or talking (mania); other unusual
changes in mood or behavior
-
Do not stop taking HORIZANT without first talking to
your healthcare provider.
Suicidal thoughts or actions can be
caused by things other than medicines. If you have these thoughts or
actions, your healthcare provider may check for other causes.
-
HORIZANT may cause a serious or life-threatening allergic reaction that
may affect your skin or other parts of your body such as your liver or
blood cells. You may or may not have a rash with these types of
reactions. Call a healthcare provider right away if you have any of
the following symptoms: skin rash, hives, fever, swollen glands that
do not go away, swelling of your lips or tongue, yellowing of your
skin or eyes, unusual bruising or bleeding, severe fatigue or
weakness, unexpected severe muscle pain, or frequent infections. These
symptoms may be the first signs of a serious reaction. A healthcare
provider should examine you to decide if you should continue taking
HORIZANT.
-
HORIZANT is not the same medicine as gabapentin (for example, Neurontin® and
Gralise®). HORIZANT should not be used in their place. Do
not take these or other gabapentin products while taking HORIZANT.
-
Before taking HORIZANT, tell your healthcare provider if you:
-
have or have had kidney problems or are on hemodialysis
-
have or have had depression, mood problems, or suicidal thoughts or
behavior
-
have or have had seizures
-
have a history of drug abuse
-
have any other medical conditions
-
are pregnant or plan to become pregnant. It is not known if HORIZANT
will harm your unborn baby. Talk to your healthcare provider if you
are pregnant or plan to become pregnant while taking HORIZANT. You and
your healthcare provider will decide if you should take HORIZANT while
you are pregnant
-
are breastfeeding or plan to breastfeed. Your body turns HORIZANT into
another drug (gabapentin) that passes into your milk. It is not known
if this can harm your baby. You and your healthcare provider should
decide if you will take HORIZANT or breastfeed
-
drink alcohol
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Do not drink alcohol while taking HORIZANT because it may increase the
risk of side effects.
-
Tell your healthcare provider about all the medicines you take,
including prescription and non-prescription medicines, vitamins, and
herbal supplements. Taking HORIZANT with certain other medicines can
cause side effects or affect how well they work. Do not start or stop
other medicines without talking to your healthcare provider.
-
Do not stop taking HORIZANT without talking to your healthcare
provider first. If you stop taking HORIZANT suddenly, you may
develop side effects.
-
The most common side effects of HORIZANT include dizziness,
sleepiness, and headache. Tell your healthcare provider about any side
effect that bothers you or does not go away. These are not all the
possible side effects of HORIZANT. For more information, ask your
healthcare provider or pharmacist.
You are encouraged to report negative side effects of prescription drugs
to the FDA. Visit www.fda.gov/medwatch,
or call 1-800-FDA-1088. See Medication Guide.
HORIZANT, REGNITE and XENOPORT are registered trademarks of XenoPort,
Inc.
XNPT2G
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