The safety and efficacy of Savella was established in two US pivotal Phase III clinical trials involving over 2,000 patients with fibromyalgia.
The studies showed that Savella doses of 100mg/day and 200mg/day demonstrated statistically significant and clinically meaningful concurrent improvements in pain, patient global assessment and physical function. The companies expect Savella to be available in pharmacies by March 2009.
Howard Solomon, chairman and CEO of Forest Laboratories, said: “We and our partner Cypress Bioscience are very pleased to receive marketing approval for Savella, following a first-cycle review, from the FDA. Savella is a valuable new treatment for patients afflicted with fibromyalgia. Its effectiveness was evaluated based upon the multiple symptoms included in the responder analysis.”