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July 30, 2012
Depomed reported results from a phase III trial of Gralise for the treatment of pain in patients with postherpetic neuralgia (PHN). This multi-center, double-blind, randomized, placebo-controlled study enrolled 452 patients with a pain intensity score of at least four on the 11-point Numerical Rating Scale (NRS) at screening.Subjects received once-daily Gralise (gabapentin 1800mg) or placebo for 11 weeks. Results showed a significant reduction in the intensity of pain (-2.12) in Gralise subjects’ average daily pain intensity compared with placebo patients (-1.63; p=0.013). This difference from placebo was statistically significant after just one week. The drug was well tolerated. The most frequent adverse events were dizziness, headache and nausea. Depomed did not comment on their plans for Gralise.
April 7, 2003
NeurogesX reported positive results from a phase II trial investigating NGX-4010, a capsaicin-containing dermal patch for the treatment of postherpetic neuralgia (post-shingles pain). Results showed that 42% of subjects in the active group experienced more than a 33 % pain decrease compared to 8 % in the control group. Treatment consisted of a topical non-prescription anesthetic for one hour, followed by a one-hour patch application. Overall drug tolerability was good with no safety concerns identified. The control group received a low-concentration capsaicin patch. Subjects recorded pain intensity twice daily on an 11-point numerical scale. The double blind, randomized controlled, multi-center study evaluated the tolerability, safety and efficacy of NGX-401 in the treatment of postherpetic neuralgia. The study enrolled 44 subjects for four weeks at nine sites in the U.S.