Key Developments For Cypress Bioscience Inc
Cypress Bioscience Inc (CYPB.O) (Consolidated Issue listed on NASDAQ Global Market)
Forest Laboratories, Inc., Cypress Bioscience Inc. Say Savella Helped Symptoms Of Fibromyalgia In Late Stage Trial-AP
The Associated Press reported that Forest Laboratories, Inc. and Cypress Bioscience Inc. said that a late stage clinical trial shows their fibromyalgia drug Savella is effective at managing symptoms of the chronic condition that causes pain, depression and fatigue. The companies said patients who took Savella had less pain, and better overall health and physical function, than patients who took a placebo. In the study, 1,025 patients were assigned to receive Savella or a placebo. They were treated with a full dose for three months. Forest and Cypress said the subjects who took Savella were more likely to have at least a 30% reduction in pain, and said they were much improved or very much improved. Patients took 100 milligrams of Savella per day, which is the same dose that the FDA approved. Forest and Cypress said they will present full results from the study at a meeting of the American College of Rheumatology in Philadelphia. The most common side effects in the study were nausea, headache, constipation, hot flush, dizziness, insomnia, excessive sweating, palpitations, fatigue, rapid heartbeat, and high blood pressure.
Forest Laboratories, Inc. And Cypress Bioscience Inc. Announces Revised Timing For Commercial Availability of Savella
Forest Laboratories, Inc. and Cypress Bioscience Inc. announced that they expect to ship Savella (milnacipran HCl), a selective serotonin and norepinephrine reuptake inhibitor for the management of fibromyalgia, to wholesalers and pharmacies by mid 2009. Savella was approved by the U. S. Food and Drug Administration (FDA) on January 14, 2009 and was originally expected to be available in March 2009. The companies submitted a minor post approval cosmetic formulation change for FDA approval. A response from the FDA is anticipated no later than May, 2009.
Cypress Bioscience Inc. Acquires Personalized Medicine Technology Platform From Cellatope Corporation
Cypress Bioscience Inc. announced that it has completed a transaction to acquire Cellatope's technology platform that uses cell bound complement activation products (CB-CAP) to diagnose and monitor debilitating autoimmune disorders, including systemic lupus erythematosus (SLE/Lupus). Terms of the deal were not disclosed.
Forest Laboratories, Inc. And Cypress Bioscience, Inc. Announces FDA Approval of Savella For Management of Fibromyalgia
Forest Laboratories, Inc. and Cypress Bioscience, Inc. announced that Savella (milnacipran HCl), a selective serotonin and norepinephrine dual reuptake inhibitor, was approved by the U.S. Food and Drug Administration (FDA) 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 safety and efficacy of Savella was established in two U.S. pivotal phase III clinical trials involving over 2,000 patients with fibromyalgia. The studies showed that Savella doses of 100 mg/day and 200 mg/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.
Forest Laboratories, Inc. And Cypress Bioscience Inc. Announces Positive Results Of Phase III Study Of Milnacipran For Management Of Fibromyalgia
Forest Laboratories, Inc. and Cypress Bioscience Inc. announced positive top line results from a 1,025 patient, multicenter, double blind, placebo controlled phase III study of milnacipran for the management of fibromyalgia. These results, which confirm the findings from the two previous phase III trials, showed that milnacipran demonstrated a highly statistically significant difference to placebo in responder analyses based on a concurrent and clinically meaningful improvement in pain, patient global impression of change, and physical functioning. Comprehensive analyses of the study data will be completed in the coming weeks, and it is anticipated that further results will be presented during 2009. In this study, designated MLN-MD-03, patients with an established history of fibromyalgia were enrolled at 75 centers in North America and randomized to receive a daily dose of 100 mg of milnacipran (n=516) or placebo (n=509). The design of the double blind study included a 4 to 6 week dose escalation phase, a 12 week stable dose treatment phase, and a 2 week discontinuation phase.
