DEPOMED RELEASES POSITIVE DATA ON DPN DRUG

Depomed has announced statistically significant efficacy benefits of its Gabapentin GR extended-release tablets for the once-daily treatment of pain in patients with diabetic peripheral neuropathy (DPN), a nerve disorder caused by diabetes.

The multicenter, double-blind, placebo-controlled, Phase II clinical trial involved 147 randomized patients with diabetic peripheral neuropathy. Patients were randomized into one of three treatment groups: 3,000 mg Gabapentin GR dosed once or twice daily or placebo. The primary objective of the four-week study was to assess the efficacy of Gabapentin GR in treating the pain associated with DPN.

Reductions in average daily pain scores from baseline to the end of treatment based on the 11-point Likert pain scale were statistically significant with once-daily Gabapentin GR. Clinically significant improvements in the pain score were observed with a mean change from baseline to study end of -2.45 compared with -1.26 for placebo. Although not statistically significantly different for twice-daily Gabapentin GR, there was pain improvement with a reduction in mean daily pain score of -1.75 with Gabapentin GR compared with -1.26 with placebo.

The secondary endpoint analysis of responders, defined as patients with at least a 50 percent reduction in pain at endpoint compared with baseline, showed that both once- and twice-daily Gabapentin GR arms reached statistical significance. The proportion of responders was 35 percent for once-daily Gabapentin GR, 26 percent for twice-daily and 8 percent for placebo.