FDA approves Forest Labs', Cypress Bioscience's Savella for fibromyalgia treatment
NEW YORK The Food and Drug Administration has approved a new drug for treating the chronic pain diseases fibromyalgia.
Forest Labs and Cypress Bioscience announced Wednesday that the FDA had approved Savella (milnacipran hydrochloride), a drug belonging to the class known as selective serotonin and norepinephrine dual reuptake inhibitors.
"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, including pain, patient global assessment and physical function," Cypress Bioscience chairman and CEO Jay Kranzler said in a statement.
Fibromyalgia causes widespread pain and decreased physical function. It affects up to 6 million people in the United States.
"Fibromyalgia is a chronic and often debilitating condition, with a significant need for new therapies," Forest chairman and CEO Howard Solomon said in a statement.