Depomed, Inc. (NASDAQ:DEPO) today announced that it has received final meeting minutes from the FDA for a pre-NDA meeting related to DM-1796 for postherpetic neuralgia (PHN) held in December 2009. Depomed also commented on recent public disclosures related to the Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Horizant™ (gabapentin enacarbil) Extended-Release Tablets. Horizant is an investigational treatment for moderate-to-severe primary Restless Legs Syndrome developed by Xenoport, Inc. and licensed to GlaxoSmithKline.
Depomed noted that unlike Horizant, Depomed’s proprietary extended release formulations of gabapentin are not new chemical entities that require additional carcinogenicity or other toxicology studies. Depomed expects an NDA for DM-1796 will be filed in the first quarter of this year under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act. Depomed believes that no additional carcinogenicity studies will be required for the DM-1796 NDA because it will reference the same toxicology package that formed the basis of the approval of Neurontin® (gabapentin) for epilepsy and postherpetic neuralgia.
Depomed noted that gabapentin is a well-characterized compound that has been marketed for epilepsy since 1993 and PHN since 2002. The compound has not shown a carcinogenicity signal in post-marketing experience involving approximately 20 million prescriptions annually.
DM-1796 Pre-NDA Meeting
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.
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.