New Treatment For Fibromyalgia
The first new medication for treatment of fibromyalgia syndrome (FMS) has received U.S. Food and Drug Administration (FDA) approval. Fibromyalgia is an enigmatic disease that is associated with chronic widespread pain, sleep disturbances, fatigue, and depression. The disease affects some 12 million people in the U.S., and 11 million of these sufferers are women.
Got The Nod
The FDA gave a nod to the drug, called Savella, on January 14, 2009. Savella is the brand name for milnacipran HCL, an antidepressant from the selective serotonin and norepinephrine reuptake inhibitor (SSNRI) class. The drug is being produced by Forest Laboratories in New York City, as licensed by Cypress Bioscience in San Diego.
SSNRIs help neurons, or nerve cells, in the brain, to communicate with each other through the use of serotonin and norepinephrine, which are neurotransmitters. These neurotransmitters have major impact on the regulation of both mood and pain perception.
Available In March
Up until now, there were only two drugs available as specific therapy for the treatment of fibromyalgia. One of these two drugs is Cymbalta, which is produced by Eli Lilly and is both an antidepressant and a pain reliever. The other drug is Lyrica, a drug produced by Pfizer. Lyrica works to control pain and seizures. Savella's producers have announced that the new drug will be made available to U.S. pharmacies by March of this year (2009).
The American College of Rheumatology claims that the number of U.S. fibromyalgia sufferers occupies 4% of the total population. Scientists have yet to pinpoint the cause of this mysterious condition, but it becomes clearer every day that both heredity and long-term stress may be factors.
This latest addition to the fibromyalgia pharmacopeia comes just after the Journal of the American Medical Association (JAMA) published the results of a study showing that traditional antidepressants like Savella reduce many of the symptoms of fibromyalgia. Marketed as Ixel and Toledomin, milnacipran (Savella) is already approved for use in many countries throughout South America, Asia, and Europe.
Rae Marie Gleason, the executive director of the National Fibromyalgia Association, a nonprofit organization located in Anaheim, California feels that none of the three drugs approved for fibromyalgia treatment, Cymbalta, Lyrica, and now Savella, provide total relief from symptoms or effect a reduction of symptoms in all patients. Gleason comments, "It's definitely a step in the right direction, but it's not the final answer," and believes that researchers must continue to press on in their research, in particular in areas such as "combination treatments [combining medication with counseling and exercise] and other medicines that might come on board."