Firms expect it to be available in March.
FDA has approved Forest Laboratories’ and Cypress Bioscience’ fibromyalgia treatment, Savella™. The companies expect that the drug will be available in pharmacies by March 2009.
Savella will be marketed by Forest and its licensor, Cypress Bioscience. Pierre Fabre, which originally developed and sells the compound outside the U.S., licensed the North American rights to Cypress Bioscience.
Savella is a dual-reuptake inhibitor that preferentially blocks the reuptake of norepinephrine with higher potency than serotonin. These two neurotransmitters are thought to a play a central role in the symptoms of fibromyalgia.
Savella went through two Phase III trials involving over 2,000 patients with fibromyalgia. “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,” notes Jay D. Kranzler, M.D., Ph.D., chairman and CEO of Cypress Bioscience. “Savella is the only product approved for the management of fibromyalgia that used this complete responder analysis as its primary endpoint.”