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