Depomed licensee submits DM-1796 NDA for management of PHN

Mar 31 2010

Depomed, Inc. (NASDAQ: DEPO) today announced that its licensee has submitted a New Drug Application (NDA) for DM-1796 to the U.S. Food and Drug Administration (FDA) for the management of postherpetic neuralgia (PHN), or pain after shingles. DM-1796 is an investigational, extended release, once-daily tablet formulation of gabapentin designed to reduce dosing frequency and have a low incidence of side effects.

“There continues to be a need for new and improved therapies.”

The application follows the completion of a randomized, double-blind, placebo-controlled Phase 3 study of 452 PHN patients. The study demonstrated that DM-1796 achieved a statistically significant reduction in average daily pain score associated with PHN versus placebo using the numerical Likert pain scale.

"PHN is a serious problem and can profoundly undermine the health and quality of life of patients who experience this complication," explained Russell Portenoy, M.D., Chairman of the Department of Pain Medicine and Palliative Care at Beth Israel Medical Center and Professor of Neurology and Anesthesiology at the Albert Einstein College of Medicine, both in New York. "There continues to be a need for new and improved therapies."

"The NDA submission is a significant milestone in the development of DM-1796," said Carl Pelzel, president and chief executive officer of Depomed. "We are excited about the product potential in North America, where it is partnered with Abbott Products, and also outside of North America, where we are actively pursuing partnering discussions."

"We believe that DM-1796 can provide significant clinical benefits to patients with its once-daily dosing and reduced side effects. DM-1796 is targeting a market where almost half of patients obtain less than optimal results with current treatments," added Mike Sweeney, M.D., Depomed's vice president, Research and Development.