Depomed Initiates Phase II Trial for Gabapentin ER in Pain Indication

Depomed has initiated a Phase II clinical trial to evaluate the safety and efficacy of its Gabapentin extended-release (ER) tablets to treat patients with postherpetic neuralgia, a long-lasting pain condition associated with nerve damage from herpes zoster, or shingles, infection.

The randomized, double-blind, placebo-controlled trial is expected to include approximately 25 U.S. sites and 150 postherpetic neuralgia patients. The primary objective is to assess the efficacy of Gabapentin ER twice daily compared to placebo in reducing mean daily pain scores. In addition, the trial will evaluate other safety and efficacy parameters, including sleep interference, a common problem of patients in pain.