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news.FDA has accepted Depomed's new drug application (NDA) for DM-1796, for the management of postherpetic neuralgia (PHN).
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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.
Depomed claimed that the drug features an extended release formulation which allows for the drug to be gradually absorbed into the blood. This reduces the frequency of peak concentrations commonly seen with immediate release formulations currently on the market.
Depomed has reported that the NDA follows the completion of a randomised, double-blind, placebo-controlled Phase 3 study of 452 PHN patients.
The study result suggested that DM-1796 achieved a reduction in average daily pain score associated with PHN versus placebo using the numerical Likert pain scale.
Carl Pelzel, president and CEO of Depomed, said: “We are pleased the NDA was accepted for DM-1796. The acceptance triggers a $10m milestone payment from our licensee. We look forward to the approval of DM-1796, which we believe can provide significant clinical benefits to patients.”