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GlaxoSmithKline And XenoPort Receive FDA Approval For Horizant™

“This significant milestone represents the culmination of XenoPort’s efforts to develop a non-dopaminergic therapy for patients with Restless Legs Syndrome,” said Ronald W. Barrett, Ph.D., XenoPort’s chief executive officer. “XenoPort is honored to have contributed to the efforts to find new treatments for Restless Legs Syndrome, and we hope that we can continue to develop other important medicines that can provide meaningful treatment benefit to sufferers of central nervous system disorders.”

IMPORTANT SAFETY INFORMATION about Horizant (gabapentin enacarbil)

The recommended dosage of Horizant (gabapentin enacarbil) is 600 mg once daily taken with food at about 5:00 pm. A daily dose of 1,200 mg provided no additional benefit compared with the 600-mg dose, but caused an increase in adverse reactions.

Gabapentin enacarbil causes significant driving impairment. Patients being treated with gabapentin enacarbil should not drive until they have gained sufficient experience to assess whether gabapentin enacarbil impairs their ability to drive. However, prescribers and patients should be aware that patients’ ability to assess their own driving competence, as well as their ability to assess the degree of somnolence caused by gabapentin enacarbil, can be imperfect.

Gabapentin enacarbil causes somnolence/sedation and dizziness. Patients should be advised not to drive a car or operate other complex machinery until they have gained sufficient experience on gabapentin enacarbil to assess whether gabapentin enacarbil impairs their ability to perform these tasks.

Gabapentin enacarbil is a prodrug of gabapentin, an antiepileptic drug (AED). AEDs increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Because Horizant is a prodrug of gabapentin, gabapentin enacarbil also increases this risk. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

When discontinuing gabapentin enacarbil, patients receiving the recommended dose of 600 mg daily can discontinue the drug without tapering. If the recommended dose is exceeded, the dose should be reduced to 600 mg daily for one week prior to discontinuation to minimize the potential of withdrawal seizure.

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