Depomed finalizes phase 3 clinical trial protocol for Gabapentin GR

By Elaine Rigoli

Tampa, Fla., May 10 - Depomed, Inc. said it finalized the phase 3 clinical trial protocol for Gabapentin GR in conformance with requirements from the Food and Drug Administration.

Gabapentin GR extended-release tablets are in development for the treatment of post-herpetic neuralgia, a long lasting pain condition caused by nerve damage during a shingles, or herpes zoster, viral infection.

The randomized, double-blind, placebo-controlled study will include approximately 400 patients with post-herpetic neuralgia and will involve approximately 75 centers across the United States. The primary goal is to evaluate 1,800 mg twice-daily Gabapentin GR compared to a placebo, as well as an arm to evaluate once-daily Gabapentin GR against a placebo, the company said in a news release.

Each patient will receive the 1,800 mg dose for eight weeks and the primary endpoint for the study will be a reduction in pain score as measured from baseline using the Likert pain scale, a numerical rating to assess pain intensity.

A secondary endpoint will be a measurement of sleep interference, a common issue if patients experience breakthrough pain during the night, the release said.

Earlier this year, the company reported results from its phase 2 trial with Gabapentin GR, which closely mirrors the phase 3 clinical trial protocol, but was shorter in duration. In the phase 2 trial in 158 patients, reductions in average daily pain scores were statistically significant with twice-daily Gabapentin GR from week two to the end of treatment based on the Likert pain scale, the release said.

Depomed is a pharmaceutical company located in Menlo Park, Calif.

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