Depomed initiates phase II clinical trial for Gabapentin ER in pain indication
Depomed, Inc. announced that it has initiated a Phase II clinical trial to evaluate the safety and efficacy of its Gabapentin extended release tablets to treat patients with postherpetic neuralgia, a long-lasting pain condition associated with nerve damage from herpes zoster, or shingles, infection.
"We are excited to have another product enter advanced-stage clinical testing," said John W. Fara, Ph.D., chairman and chief executive officer of Depomed. "With two products currently under review at the FDA and nearing commercialization, we understand the importance of a steady steam of programs which can expand our product offerings and continue to build shareholder value."
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.
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