March 31, 2010
NDA submitted for DM-1796 for postherpetic neuralgia (PHN)Depomed, Inc. announced that its licensee, Abbott Laboratories, has submitted a New Drug Application (NDA) for DM-1796 (extended-release gabapentin) to the FDA for the management of postherpetic neuralgia (PHN), or pain after shingles. This submission follows the completion of a randomized, double-blind, placebo-controlled Phase 3 study of 452 PHN patients. The study demonstrated that DM-1796 achieved a statistically significant reduction in average daily pain score associated with PHN versus placebo using the numerical Likert pain scale.
DM-1796 is an investigational extended release, once-daily tablet formulation of gabapentin for the treatment of PHN.
For more information call (800) 633-9110 or visit www.abbott.com.