Depomed Inc (NASDAQ:DEPO) scuttles SEFELSA development
Depomed, Inc. (Nasdaq:DEPO) is a specialty Pharma company. On Friday, the company announced that the U.S. FDA has issued a complete response letter (CRL) to the NDA for DEPOs investigational, oral medication, SEFELSA. This twice-daily gabapentin formulation is used in the treatment of moderate to severe vasomotor symptoms that are a result of menopause. The CRL stated that the United States Food Drug Administration cannot approve DEPO’s application in the present form. Based on this letter, the company no longer currently wishes to make any further investments in SEFELSA.
The President and Chief Executive Officer, Jim Schoeneck said that the CRL was expected. This was with reference to SEFELSA’s FDA Advisory-Committee meeting. He reiterated that today, Depomed Inc (NASDAQ:DEPO) is a growth-oriented, product-focused specialized pharma company. Its main revenues come from Gralise and Zipsor, its marketed products. It also garners revenue from royalty income that it receives from its partnered technology and products. It has a strong balance sheet and also harbors the ability to turn cash-flow positive in the second half of 2013.
About the company
Depomed Inc (NASDAQ:DEPO) is a specialty Pharma company. Gralise, Zipsor Glumetza are its three, approved and marketed products. The company formulates these products and its product candidates with Acuform, its proprietary, proven drug delivery technology. This technology is designed in such a way that it aids in improving the performance of existing oral medications. It allows for the extended release of medications into the upper gastrointestinal-tract when it is dosed with food. In 2012 January, the company began a Phase II study.
This study was being conducted to evaluate DM-1992 to treat motor symptoms that are connected to Parkinson’s disease. This trial was an open-label, randomized, crossover study that had enrolled 18 patients who suffered from stable Parkinson’s disease. It was conducted at 2, neurology centers located in Russia. This innovative Acuform technology is based on Depomed Inc (NASDAQ:DEPO)’s oral drug-delivery technologies. It is designed to include different formulations of polymeric tablets that contain drugs that allow a multi-hour delivery of the incorporated drug.