Depomed Announces US Food And Drug Administration Approval Of GRALISE(TM) (gabapentin) Once-Daily Tablets For Treatment Of Post-Herpetic Neuralgia

MENLO PARK, Calif., Jan. 28, 2011 (GLOBE NEWSWIRE) -- Depomed, Inc. (Nasdaq:DEPO) today announced that US FDA has approved GRALISE™ (gabapentin) Tablets for once-daily treatment of post-herpetic neuralgia (PHN), which is pain following healing of the rash associated with shingles. GRALISE was developed by Depomed under the code name DM-1796 and is licensed to Abbott Products, Inc. in the U.S., Canada and Mexico. The approval of GRALISE triggers a milestone payment of $48 million from Abbott to Depomed.

"The approval of GRALISE is a major step toward achieving our key strategic objective of sustainable profitability in 2011 and beyond," said Carl Pelzel, President and CEO of Depomed. "I'd like to thank everyone on the Depomed and Abbott teams involved in the development and approval of this important therapy for their hard work and dedication," added Mr. Pelzel. 

Michael Sweeney, MD, Vice President of Research and Development for Depomed, noted, "We are delighted with the approval of Gralise, which marks the third FDA approval of a product developed by Depomed. Further, FDA has granted GRALISE Orphan Drug status, recognizing GRALISE as an important treatment option for patients who suffer from the pain of PHN. We are also very pleased with the product label FDA has approved."

"The GRALISE formulation of gabapentin allows for once-a-day dosing and a tolerability profile that will be a positive addition to physicians' treatment armamentarium," said Gordon Irving, MD, Medical Director of the Swedish Pain and Headache Center, Clinical Associate Professor, University of Washington Medical School in Seattle, Washington. "Patients with PHN have long struggled to manage pain following herpes zoster infection. Current therapies require dosing multiple times per day and come with a high incidence of troubling side effects."

About GRALISE ^TM

GRALISE was approved on the basis of two phase 3 trials involving 359 patients treated with GRALISE and 364 treated with placebo. Safety was evaluated in all 723 patients and the efficacy assessment was based on the second phase 3 trial, a randomized, double-blind, placebo-controlled study of 452 PHN patients. In this trial, GRALISE achieved a statistically significant reduction in average daily pain score compared to placebo. Patients in the study were randomized into two treatment arms: placebo or 1800 mg of GRALISE dosed once-daily. Secondary objectives included an assessment of changes from baseline in sleep interference, and additional patient and clinician assessments of pain and quality of life.