The FDA has approved Gralise (gabapentin tablets, from Depomed) for the once-daily treatment of post-herpetic neuralgia (PHN). Gralise tablets are formulated to swell in gastric fluid and gradually release gabapentin. The approval of Gralise was based on data from two Phase 3, randomized, double-blind, placebo-controlled trials involving 732 patients with PHN. Data demonstrated that patients treated with Gralise achieved a statistically significant reduction in average daily pain score compared to placebo. Gralise is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration.
Gralise is expected to be available later this year in 300mg and 600mg dosage strengths.
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