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news.Depomed has said that its licensee has submitted a new drug application (NDA) for DM-1796 to the USFDA for the management of postherpetic neuralgia (PHN), or pain after shingles.
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DM-1796 is an investigational, extended release, once-daily tablet formulation of gabapentin formulated to reduce dosing frequency and have a low incidence of side effects.
The application was a result of the completion of a randomized, double-blind, placebo-controlled Phase 3 study of 452 PHN patients. The study showed that DM-1796 achieved a statistically significant reduction in average daily pain score associated with PHN versus placebo using the numerical Likert pain scale.
Carl Pelzel, president and chief executive officer of Depomed, said: “The NDA submission is a significant milestone in the development of DM-1796. 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.”
Mike Sweeney, vice president of research and development at Depomed, said: “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.”