Drug news
FDA approves Horizant (GlaxoSmithKline/XenoPort) for Postherpetic Neuralgia in adults
The FDA has approved Horizant (gabapentin enacarbil) extended-release tablets, from GlaxoSmithKline / XenoPort, for Postherpetic Neuralgia in adults. Approval is based on a single 12-week principal efficacy trial, plus two supportive studies that all met their respective primary endpoints. The three clinical studies involved 574 adult patients from the US, Canada and Germany. Somnolence and dizziness were the most frequently reported side effects. The drug was approved by the FDA for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) in April 2011.
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