New Drug Approved for Fibromyalgia Treatment

On the heels of the recent news that anti-depressants are beneficial to fibromyalgia patients, the FDA has approved a new medication specifically for the treatment of this “invisible syndrome." Savella is a product of Forest Laboratories, Inc. and Cypress Bioscience, Inc. and the companies report that the FDA approved the drug based on two clinical trials. The trials consisted of  2,084 fibromyalgia patients, who took either Savella or a placebo for a period of three months or six months.

Savella is in a class of drugs which are called serotonin or norepinephrine reuptake inhibitors (SNRIs). This group of drugs includes some antidepressants. Although the exact way the drug works is not known, it is believed that it may affect abnormalities in certain brain neurotransmitters. The manufacturers believe that their product is superior to other drugs used to treat fibromyalgia because it is the only medication approved to treat pain, function, and overall well-being.

The patients who took Savella reported at least a 30 percent reduction in pain and by their own ratings were “very much improved” or “much improved” in relation to their fibromyalgia. According to information furnished by the companies, the drug was safe and generally well tolerated. Nausea was the most common side effect in the clinical trials. Other adverse reactions were constipation, hot flush, sweating, vomiting, palpitations, increased heart rate, dry mouth, and high blood pressure.

Savella is only approved for adults. When available for prescribing, expected in March, it will have the same “black box” warning as antidepressants about the increased risk of suicidal thinking and behavior in children, adolescents, and young adults. As with all medications Savella will have a guide outlining its risks. The FDA is also requiring studies regarding pregnancy and fetal outcomes in women who take Savella while pregnant. There will be a clinical trial of the drugs effects on babies exposed through breastfeeding.

If Savella can bring relief to at least some of the 6 million in the United States who suffer from fibromyalgia it would be a welcome addition to treatment. During the tests some participants withdrew because of the side effects, but with continued work and research science may yet find relief for this mysterious disease.