The Experts Speak

Big News

Big news is in the cards for those with fibromyalgia syndrome (FMS), a chronic ailment characterized by chronic widespread pain, fatigue, sleep disturbances, and depression. A new drug received U.S. Food and Drug Administration (FDA) approval on January 14, 2009, lending hope for some relief for the 4% of Americans afflicted with the condition. The New York City-based Forest Laboratories, Inc., and its licensor, Cypress Bioscience, located in San Diego, California announced the approval of their drug, Savella (milnacipran HCI), a selective serotonin and norepinephrine dual reuptake inhibitor (SSNRI) for the management of fibromyalgia syndrome.

Deemed Safe

Savella has been deemed both safe and effective after undergoing two U.S. phase III trials with the help of more than 2000 fibromyalgia sufferers as participants. The studies demonstrated that doses of 100 or 200 mg. of Savella per day gave patients significant improvement in terms of pain reduction and other fibromyalgia-associated symptoms. Forest Laboratories and Cypress Bioscience believe their prescription product will be available in pharmacies by March of 2009.

Dr. Daniel Clauw, a University of Michigan professor of anesthesiology and medicine (rheumatology) comments, “Fibromyalgia is a complicated chronic pain condition, so it is important that physicians and patients have access to treatments that have been shown to help manage the symptoms that define the experience of fibromyalgia. The introduction of Savella is important because it is the first drug approved to treat the symptoms of fibromyalgia using a composite responder analysis.”

Primary Endpoint

The chairman and CEO of Cypress Bioscience, Jay D. Kranzler, MD, PhD, elaborates, “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. Savella is the only product approved for the management of fibromyalgia that used this complete responder analysis as its primary endpoint.”

Forest Laboratories chairman and chief executive officer Howard Solomon had this to say about the new drug, “We and our partner Cypress Bioscience are very pleased to receive marketing approval for Savella, following a first-cycle review, from the FDA. Fibromyalgia is a chronic and often debilitating condition with a significant need for new therapies. 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.”

Crucial Approval

The original producer of milnacipran, Pierre Fabre Laboratories, is thrilled about the news. Chief executive officer of Pierre Fabre SA emphasized that, “This approval is crucial for Pierre Fabre Laboratories as milnacipran is one of the flagship products of our portfolio and represents another product of Pierre Fabre research registered in the United States.”