FDA Approves Savella for treatment of Fibromyalgia

Filed in archive Drugs, Vaccines and Therapeutics on January 16, 2009

Photo courtesy of iStockphoto, Image# 2902632

The FDA has approved a new drug for the management of fibromyalgia. Savellaâ„¢ (milnacipran HCl), developed by FOREST LABORATORIES, Inc.and Cypress Bioscience, Inc., is a selective serotonin and norepinephrine dual reuptake inhibitor.

Two US phase III clinical trials involving over 2,000 patients with fibromyalgia have shown that Savella doses of 100 mg/day and 200 mg/day resulted to 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. Savella will be third FDA-approved fibromyalgia drugs, which include the nerve pain drug Lyrica and the SNRI antidepressant Cymbalta.

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