The FDA has approved Forest Laboratories and Cypress Bioscience's fibromyalgia drug Savella. Fibromyalgia is a chronic condition characterized by joint and muscle pain and decreased physical functioning which affects an estimated 6 million Americans. Only two other drugs--Pfizer's Lyrica and Eli Lilly's Cymbalta--are approved to treat the condition.
In clinical studies, Savella demonstrated statistically significant and clinically meaningful concurrent improvements in pain, patient global assessment, and physical function. "Savella is the product of a unique clinical development program, one that considered a patient to be a responder to therapy only if they demonstrated concurrent clinically significant changes in multiple aspects of their fibromyalgia... Savella is the only product approved for the management of fibromyalgia that used this complete responder analysis as its primary endpoint," said Jay D. Kranzler, MD, PhD, Chairman and CEO of Cypress Bioscience. The companies said they expect to market the drug by March.
- here's the press release
- see this article for more