Depomed Announces Publication Of Phase 3 Data From Gralise® (gabapentin) Clinical Trial

MENLO PARK, Calif , July 23, 2012 /PRNewswire/ -- Depomed, Inc. (NASDAQ: DEPO) today announced that a report of Phase 3 data published online this month, ahead of the print edition,   in the Clinical Journal of Pain showed that once-daily Gralise ^® (gabapentin) tablets (1,800 mg) formulation significantly reduces intensity of pain in patients with postherpetic neuralgia (PHN). The results showed that patients treated with Gralise experienced a significant reduction (- 2.12) in their average daily pain intensity compared with placebo treated patients (-1.63; P=0.013). This difference from placebo was statistically significant after one week and continued to be superior through the duration of the study.

The published results are from a randomized, multi-center Phase III clinical study of 452 patients with PHN that evaluated the efficacy and safety of once-daily Gralise compared to placebo. Other results showed that the frequency of adverse events commonly associated with gabapentin was as follows: dizziness (11.3% vs. placebo, 1.7%), somnolence (5.4% vs. placebo 3.0%), and peripheral edema (3.2% vs. placebo, 0.4%) with differences in dizziness and peripheral edema being statistically significant.   Secondary endpoints showed that 43% of patients treated with Gralise reported "much" or "very much" improvement compared to 34% of placebo treated patients (P<0.0434).



"Our research shows that patients treated with Gralise experienced significant reduction of their daily pain intensity," said Christine N. Sang, MD, MPH, director of Translational Pain Research, Brigham and Women's Hospital, Harvard Medical School.  "This finding is encouraging because the pain associated with PHN has a significant impact on patients' daily lives and these results suggest that Gralise, in part because of its gastroretentive formulation, could fill an important treatment gap for patients with PHN."

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