Depomed, Inc's New Drug Application (NDA) for DM-1796 was accepted by the US 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.
"We are pleased the NDA was accepted for DM-1796. The acceptance triggers a US$ 10 million milestone payment from our licensee," said Carl Pelzel, president and chief executive officer of Depomed. "We look forward to the approval of DM-1796, which we believe can provide significant clinical benefits to patients."
DM-1796 is an investigational, once-daily therapy for the management of postherpetic neuralgia. It features a unique extended release formulation which allows for the drug to be gradually absorbed into the blood.
Depomed is a specialty pharmaceutical company with one product candidate through phase-3 clinical development, another in phase-3 clinical development, two approved products on the market and other product candidates in its early stage pipeline.