HORIZANT (gabapentin enacarbil) Included in New Expert Recommendations on Prevention and Treatment of RLS Augmentation

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.

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