Depomed, Inc. stock moved up $1.25 to $5.66 in robust trading today on word of top-line results for Phase 3 clinical trials of its new drug. DM-1796 (gabapentin ER) is a newly formulated, once-daily pain relief drug for postherpetic neuralgia (PHN), a persistent condition caused by nerve damage from having shingles. The drug passed FDA’s baseline observation carried forward (BOCF) methodology, and spiked the pain reduction curve on the Lickert pain scale in a ten-week observation period.
Solvay Pharmaceuticals, Inc. has been granted a license for DM-1796 in North American markets. In a statement, president and CEO of Depomed, Carl A. Pelzel, said that this study validated the company’s proprietary Acuform® drug delivery technology, and that he looked forward to working with Depomed’s partner, Solvay, to get this drug through FDA regulations and into the hands of eager patients.
Dr. Michael Sweeney, V.P. of R&D for Depomed, commented on the unique potential of the new, extended-release formulation to satisfy PHN sufferers who historically are unable to find an adequate pain relief. This new formulation also offers reduced side effects, and in a double-blind study of 452 patients, only minor side effects (dizziness, 9.5%; somnolence, 2.4%) were observed.
While a full study of the test results is underway, Depomed has released a webcast on their site discussing results of the trial and announcing that a new Drug Application (NDA) would be submitted to FDA by the end of FQ 2010.
Depomed, Inc. currently has Glumetza® and ProquinXR® approved, and on the market, for type 2 diabetes and urinary tract infections respectively. With another Phase 3 trial drug for menopausal hot-flashes in development (SeradaTM), and an ongoing development pipeline for new drugs, DM-1796 is poised to join the Depomed front line, making the Company even stronger.