SANTA CLARA, Calif.--(BUSINESS WIRE)--XenoPort, Inc. (Nasdaq:XNPT) announced today that it will present data for HORIZANT® (gabapentin enacarbil) Extended-Release Tablets at the American Pain Society 34th Annual Scientific Meeting in Palm Springs, CA.
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:
Weight Change in Adults with Postherpetic Neuralgia Receiving
Gabapentin Enacarbil in a Randomized, Placebo-Controlled Trial
- Poster 392; Thursday, May 14, 3:45–5:15 pm
The Effect of Gabapentin Enacarbil (GEn) on Adverse Events (AEs) by
Age Group in a Randomized, Placebo-Controlled Trial of Patients with
Postherpetic Neuralgia (PHN)
- Poster 396; Thursday, May 14, 3:45–5:15 pm
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.
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
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.
HORIZANT, REGNITE and XENOPORT are registered trademarks of XenoPort, Inc.