Forest Lab (FRX) and Cypress Bio (CYPB) Announce Savella Phase III Results
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Forest Laboratories, Inc. (NYSE: FRX) and Cypress Bioscience, Inc. (NASDAQ: CYPB) today announced that Savella (milnacipran HCI) 100 mg/day (50 mg twice daily) demonstrated statistically significant and clinically meaningful concurrent improvements in pain, patient global assessment, and physical function, according to results from a large-scale, Phase III clinical trial that will be presented on Tuesday, October 20, 2009, at the American College of Rheumatology Annual Meeting in Philadelphia, PA.
100 mg/day is the recommended dose of Savella. Savella is a selective serotonin and norepinephrine dual reuptake inhibitor (SNRI) that was approved by the U.S. Food and Drug Administration (FDA) earlier this year for the management of fibromyalgia.
Fibromyalgia is a chronic condition characterized by widespread pain and decreased physical function, afflicting as many as six million people in the United States. The study showed statistically significant and clinically meaningful concurrent improvements in pain, patient global assessment, and physical function, among patients receiving Savella treatment of 100 mg/day, as compared to a placebo treatment group, when measured by patient-reported outcomes assessed in composite responder analyses. These results at the 100 mg/day dose are consistent with those of previous clinical trials that have demonstrated the safety and efficacy of Savella at doses of 100 mg/day and 200 mg/day.
Savella was generally well tolerated in the study. The most common treatment emergent adverse events observed during the placebo-controlled trial included nausea, headache, constipation, hot flush, dizziness, insomnia, hyperhidrosis, palpitations, fatigue, tachycardia, and hypertension. The majority of adverse reactions reported were mild to moderate in nature.
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