GlaxoSmithKline and XenoPort announced that the FDA has approved Horizant (gabapentin enacarbil) extended-release tablets for the management of postherpetic neuralgia (PHN) in adults. This approval was based on data from three clinical studies involving 574 adult patients from the United States, Canada, and Germany evaluated the efficacy and safety of Horizant for the management of PHN in a single 12-week principal efficacy trial. In addition, there were two additional supportive studies that all met their respective primary endpoints.
Horizant is a prodrug of gabapentin, which binds to a specific type of calcium channel but does not exhibit affinity for other common receptors. It is already indicated for treatment of moderate-to-severe primary restless legs syndrome (RLS) in adults in a 600mg dosage strength extended-release tablet.
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