XenoPort Inc (XNPT) and GlaxoSmithkline Plc (GSK) Thursday jointly announced that the U.S. Food and Drug Administration, or the FDA, has granted approval for the Horizant Extended Release Tablets for the management of postherpetic neuralgia, or PHN, in adults.
XenoPort stated that the efficacy and safety of Horizant for the management of PHN was evaluated in 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.
XenoPort further stated that it is entitled to receive a milestone payment of $10 million from GSK in association with GSK's first commercial sale of the product after approval for PHN,
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