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news.DM-1796, intended for the treatment of Postherpetic Neuralgia
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Depomed has reported top-line results from a phase 3 clinical trial of DM-1796, also referred to as gabapentin ER. It showed to achieve a significant reduction in pain associated with postherpetic neuralgia (PHN) versus placebo using the baseline observation carried forward (BOCF) method required by FDA.
Reportedly, 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 in the US, Canada and Mexico for the treatment of pain.
The randomised, double-blind, placebo-controlled study involved 452 PHN patients. Patients in the study were randomised into two treatment arms, placebo or 1800mg of DM-1796 dosed once-daily. The result suggested that treatment with DM-1796 was well tolerated.
The secondary objectives included an assessment of changes from baseline in sleep interference, and additional patient and clinician assessments of pain and quality of life.
The company said that a New Drug Application (NDA) for DM-1796 for the treatment of PHN is expected to be submitted to the FDA by the end of first quarter of 2010.
Carl Pelzel, president and CEO of Depomed, said: “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 Solvay Pharmaceuticals, through the regulatory process and making DM-1796 a commercial success.”
Michael Sweeney, vice president of research and development at Depomed, said: “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.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.”