HORIZANT (gabapentin enacarbil) Included in New Expert Recommendations on Prevention and Treatment of RLS Augmentation
June 08 2015 - 8:30AM
Business Wire
XenoPort, Inc. (Nasdaq:XNPT) reported today that new expert
recommendations for the prevention and treatment of augmentation in
patients suffering from restless legs syndrome (RLS) list
gabapentin enacarbil as a first-line therapy with a lower risk of
developing augmentation. In addition, gabapentin enacarbil is
listed as an alternative treatment for the management of patients
suffering from augmentation who were previously treated with
dopaminergic medication. RLS augmentation is an insidious worsening
of RLS symptoms that can occur after treatment of RLS with
dopaminergic medication. The recommendations were created by the
combined Task Force from the International RLS Study Group
(IRLSSG), the European RLS Study Group (EURLSSG) and the RLS
Foundation.
"With up to 10 million Americans suffering from RLS, medical
professionals need updated treatment algorithms to ensure that
previously untreated patients receive appropriate first-time
treatment," said William Ondo, M.D., professor, Department of
Neurology, University of Texas Health Science Center at Houston and
Task Force member. "These new RLS augmentation recommendations are
an important tool for physicians to help prevent augmentation in
RLS patients and to provide treatment options for those who have
already experienced augmentation."
HORIZANT® (gabapentin enacarbil) Extended-Release Tablets
is the only non-dopaminergic medication and the only alpha-2-delta
calcium-channel ligand class medicine approved by the U.S. Food and
Drug Administration (FDA) for the treatment of moderate-to-severe
primary RLS in adults.
The new recommendations for RLS augmentation state that
physicians “should consider initially managing symptoms with
non-dopaminergic drugs unless the risk of potential side effects is
felt to outweigh the benefit of avoiding the risk of augmentation.”
In addition, if a patient is experiencing augmentation, the
recommendations state that the physician should “reduce and, if
possible, eliminate the short acting dopamine agonist and to begin
treatment with a long acting dopamine agonist or an alpha-2-delta
calcium-channel ligand.”
“XenoPort is proud to have led the effort that resulted in the
availability of HORIZANT, the only FDA-approved non-dopaminergic
treatment for RLS,” stated Ronald W. Barrett, Ph.D., chief
executive officer of XenoPort, Inc. “These new recommendations
reinforce the need for RLS treatment options and help ensure that
physicians have the most up-to-date information about preventing
and treating RLS augmentation.”
“Augmentation can negatively impact many aspects of a patient’s
life,” said Karla M. Dzienkowski, R.N., B.S.N., executive director
of the RLS Foundation. “These new recommendations are an important
advancement for patients suffering from augmentation and may lead
to a reduction in the number of patients experiencing augmentation
in the future.”
The IRLSSG recommendations can be found at www.IRLSSG.org
About Restless Legs Syndrome (RLS)
RLS, also known as Willis Eckbom Disease (WED), is a
neurological condition that causes an irresistible urge to move the
legs. This urge is usually caused or accompanied by unpleasant
sensations of burning, creeping, tugging or tingling inside the
patients' legs, ranging in severity from uncomfortable to painful.
These RLS-related symptoms typically begin or worsen during periods
of rest or inactivity, particularly when lying down or sitting, and
may be temporarily relieved by movement such as walking or
massaging the legs. Symptoms often worsen at night, and disturbed
sleep is a common result of RLS. Left untreated, moderate-to-severe
primary restless legs syndrome may cause exhaustion, daytime
fatigue, inability to concentrate and impaired memory.
About Restless Legs Syndrome Augmentation
According to the Summary of Recommendations for the Treatment of
RLS/WED Augmentation, augmentation is the main long-term
complication of dopaminergic drugs and one of the main reasons for
loss of response to dopaminergic treatment in RLS/WED. Augmentation
is a treatment-related increase in RLS/WED symptoms that emerges
with the long-term dopaminergic treatment of RLS/WED.
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® (gabapentin enacarbil) Extended-Release
Tablets
INDICATION
HORIZANT 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.
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.
- When used for RLS, the most common side
effects of HORIZANT include sleepiness and dizziness. 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.
To learn more about HORIZANT, please visit the Web site at
www.Horizant.com.
HORIZANT, REGNITE and XENOPORT are registered trademarks of
XenoPort, Inc.
XNPT2G
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version on businesswire.com: http://www.businesswire.com/news/home/20150608005438/en/
XenoPort, Inc.Jackie Cossmon, 408-616-7220ir@XenoPort.com
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