XenoPort to Present New Data Analyses for HORIZANT (gabapentin enacarbil) at the 67th Annual Meeting of the American Academy ...
April 15 2015 - 8:30AM
Business Wire
XenoPort, Inc. (Nasdaq:XNPT) announced today that it will
present pooled post-hoc analyses for gabapentin enacarbil, the
active ingredient in HORIZANT® (gabapentin enacarbil)
Extended-Release Tablets, at the upcoming 67th Annual Meeting of
the American Academy of Neurology in Washington, DC.
HORIZANT is approved by the U.S. Food and Drug Administration
(FDA) for the treatment of moderate-to-severe primary restless legs
syndrome (RLS) in adults and for the management of postherpetic
neuralgia (PHN) in adults.
The titles and presentation times for XenoPort’s posters are as
follows:
- The Effect of Gabapentin Enacarbil
(GEn) on Pain Outcomes in Adults with Moderate-to-Severe and Severe
Primary Restless Legs Syndrome (RLS): Pooled Analyses from 3
Randomized Controlled Trials
- Poster P7.294; Thursday, April 23,
2015; 2:00 p.m. ET
- The Effect of Gabapentin Enacarbil
(GEn) on Quality-of-Life (QoL) Outcomes in Adult Patients With
Moderate-to-Severe and Severe Primary Restless Legs Syndrome (RLS):
Pooled Analyses From Two 12-Week Trials
- Poster P7.299; Thursday, April 23,
2015; 2:00 p.m. ET
- The Effect of Gabapentin Enacarbil
(GEn) on Mood Outcomes in Adult Patients With Moderate-to-Severe
and Severe Primary Restless Legs Syndrome (RLS): Pooled Analyses
from Three 12-Week Trials
- Poster P7.300; Thursday, April 23,
2015; 2:00 p.m. ET
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. XenoPort assumed responsibility for commercialization of
HORIZANT in the United States in May 2013 after return of all
product rights from its former partner. 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, REGNITE and XENOPORT are registered trademarks of
XenoPort, Inc.
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
- 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
- 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.
XNPT2G
XenoPort, Inc.Jackie Cossmon, 408-616-7220ir@XenoPort.com
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