XenoPort to Present New Pooled Data Analyses on HORIZANT (gabapentin
enacarbil) at the 2014 SLEEP Annual Meeting
SANTA CLARA, Calif. -- June 2, 2014
XenoPort, Inc. (Nasdaq:XNPT) announced today that new pooled data analyses for
gabapentin enacarbil, the active ingredient of HORIZANT^® (gabapentin
enacarbil) Extended-Release Tablets, will be presented at the upcoming 28^th
Associated Professional Sleep Societies (APSS) annual SLEEP meeting in
Minneapolis. The presentations include:
*The Effect of Gabapentin Enacarbil on Individual Items of the
International Restless Legs Scale and Post-Sleep QuestionnaireIn Patients
with Severe Primary Restless Legs Syndrome: Pooled Analyses from3
Poster #286, Tuesday, June 3, 4:00-6:00 pm CDT, Exhibit Hall C.
*The Effect of Gabapentin Enacarbil on Individual Items of the
International Restless Legs Scale and Post-Sleep Questionnaire In Patients
with Moderate-to-Severe Primary Restless Legs Syndrome: Pooled Analyses
from3 Randomized Trials
Poster #287, Tuesday, June 3, 4:00-6:00 pm CDT, Exhibit Hall C.
*Evaluation of International Restless Legs Scale, Sleep, and Pain Outcomes
as Predictors of Response on the Patient-Rated Clinical Global
Impression-Improvement Scale In Patients with Moderate-to-Severe Primary
Restless Legs Syndrome Treated with Gabapentin Enacarbil: Pooled Analyses
from 2 Randomized Trials
Poster #288, Tuesday, June 3, 4:00-6:00 pm CDT, Exhibit Hall C.
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, headache, nausea and fatigue.
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 psoriasis
and/or relapsing forms of multiple sclerosis. REGNITE® (gabapentin enacarbil)
Extended-Release Tablets is being marketed in Japan by Astellas Pharma Inc.
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.
HORIZANT, REGNITE and XENOPORT are registered trademarks of XenoPort, Inc.
HORIZANT ^® (gabapentin enacarbil) Extended-Release Tablets
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
*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
*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
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
*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
*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
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
Jackie Cossmon, 408-616-7220
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