In February 2010, Depomed received final meeting minutes from the pre-NDA meeting with the FDA related to DM-1796 for PHN held in December 2009. At the pre-NDA meeting, the FDA was asked to confirm that the preclinical toxicology package for DM-1796 was sufficient. Based upon the meeting minutes, Depomed believes that the toxicology package for DM-1796 appears sufficient to support the safety of DM-1796 provided certain manufacturing specifications are met.
Depomed licensed DM-1796, an investigational extended release formulation of gabapentin for PHN, to Solvay Pharmaceuticals, Inc. in the United States and other North American territories. Solvay Pharmaceuticals was acquired by Abbott Laboratories in February 2010.
SeradaTM
Depomed also noted its SeradaTM product candidate, an investigational extended release formulation of gabapentin for menopausal hot flashes, addresses an unmet medical need in an area of women??™s health characterized by concerns linking the use of hormonal products to breast cancer and cardiovascular adverse events arising from post-marketing studies of those products. A Phase 3 trial for Serada is expected to begin by the end of April 2010. Any NDA for Serada will also reference Neurontin??™s toxicology package.
SOURCE Depomed, Inc.