Depomed, Inc. (NASDAQ:DEPO) today announced top-line results from a Phase 3 clinical trial demonstrating DM-1796 (also referred to as gabapentin ER) achieved a statistically significant reduction in pain associated with postherpetic neuralgia (PHN) versus placebo using the baseline observation carried forward (BOCF) method required by FDA. The primary endpoint measured pain scores from baseline to the end of a ten-week treatment period using the numerical Likert pain scale.
DM-1796 is an investigational extended release, once-daily tablet formulation of gabapentin for the treatment of PHN. Depomed has licensed DM-1796 to Solvay Pharmaceuticals, Inc. in the United States, Canada and Mexico for the treatment of pain.
“This study demonstrates the effectiveness of our proprietary drug delivery technology in producing meaningful clinical benefits for PHN patients. We look forward to working with our strong and committed partner, Solvay Pharmaceuticals, through the regulatory process and making DM-1796 a commercial success,” said Carl A. Pelzel, president and chief executive officer of Depomed.
“The study results represent another step forward in the potential for DM-1796 to be an important new option for patients with postherpetic neuralgia who often struggle to find effective pain relief treatments,” noted Dr. Michael Sweeney, Depomed’s vice president, Research and Development. “Gabapentin has proven efficacy, and the study data suggest that the new extended-release formulation may offer a favorable side effect profile and added convenience,” Dr. Sweeney added.