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Sr. Executive / Executive, Production; THE IBN SINA PHARMACEUTICAL IND LTD

 
Approval of Horizant (gabapentin enacarbil) by FDA
Brand Name: Horizant
Generic Name: gabapentin enacarbil
Company Name: GlaxoSmithKline and XenoPort, Inc.
Date of Approval: April 6, 2011
Treatmant for: Restless Legs Syndrome
GlaxoSmithKline and XenoPort, Inc. announced Wednesday that the U.S. Food and Drug Administration (FDA) has approved Horizant (gabapentin enacarbil) Extended-Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome in adults. Horizant is not recommended for patients who are required to sleep during the daytime and remain awake at night. The efficacy of Horizant in the treatment of patients with moderate-to-severe primary Restless Legs Syndrome was demonstrated in two 12-week clinical trials in adults. It is the first medication in its class to be approved for the treatment of moderate-to-severe primary Restless Legs Syndrome.

"Clinical experience has substantiated that Restless Legs Syndrome, also referred to as Ekbom Disease, is a long-term neurological condition characterized by an urge to move caused by unpleasant sensations in the legs," said Richard K. Bogan, M.D., FCCP, chairman and chief medical officer of SleepMed of South Carolina in Columbia, South Carolina, and a clinical trial investigator. "Our experience has shown that patients with moderate-to-severe primary Restless Legs Syndrome can suffer from a range of disruptive symptoms and may benefit from a new treatment option."

"Restless Legs Syndrome remains under-recognized, and many patients go untreated as a result," said Atul Pande, M.D., senior vice president, GlaxoSmithKline Neurosciences Medicine Development Center. "GSK has been committed to helping patients and healthcare professionals better understand and treat this condition. We are pleased to provide a new treatment for moderate-to-severe primary Restless Legs Syndrome."

Discovered and developed by XenoPort, Horizant is a new chemical entity that utilizes the body's nutrient transport mechanisms that are believed to facilitate its absorption into the body. Once absorbed, Horizant is converted into gabapentin, which binds to a specific type of calcium channel but does not exhibit affinity for other common receptors. The exact mechanism of action of Horizant in treating moderate-to-severe primary Restless Legs Syndrome is unknown. Horizant is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles. The same dose of Horizant results in different plasma concentrations of gabapentin relative to the same dose of other gabapentin products.

"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.

The dose of gabapentin enacarbil should be adjusted in subjects with renal impairment (creatinine clearance 30 to 59 mL/min); gabapentin enacarbil 600 mg should be administered on Day 1, Day 3, and every day thereafter. Gabapentin enacarbil is not recommended in patients with creatinine clearance less than 30 mL/min or in patients on hemodialysis.

In three 12-week clinical trials, the two most commonly observed adverse reactions for gabapentin enacarbil 600 mg per day (n=163), gabapentin enacarbil 1200 mg per day (n=269), and placebo (n=245), respectively, were somnolence/sedation (20%, 27%, and 6%) and dizziness (13%, 22%, and 4%).

Please see full Prescribing Information and Medication Guide available at www.gsk.com.
Note: To know more please go to the following sources.
Update: 2011-04-07
Source: Drugs.com & FDA
 
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