WebMD Medical News
Louise Chang, MD
Jan. 15, 2009 -- The FDA has approved a new drug called Savella for the management of fibromyalgia.
Savella belongs to a class of drugs called serotonin and norepinephrine reuptake inhibitors (SNRIs), which include some antidepressants.
The drug companies behind Savella -- Forest Laboratories Inc. and Cypress Bioscience Inc. -- report that the FDA approved Savella based on two clinical trials that together included 2,084 fibromyalgia patients who took Savella or a placebo for three months or six months.
Savella trumped the placebo in the percentage of patients of who reported at least a 30% reduction in pain and also rated themselves as being "very much improved" or "much improved" in terms of their fibromyalgia, according to a joint news release from Forest Laboratories and Cypress Biosciences.
Savella was safe and generally well tolerated, according to Forest Laboratories and Cypress Biosciences. The drug companies report that nausea was the most common side effect in the clinical trials and that other commonly reported adverse reactions were constipation, hot flush, sweating, vomiting, palpitations, increased heart rate, dry mouth, and hypertension (high blood pressure).
Savella, which is expected to be available by prescription in March, is only approved for adults. It will bear the same "black box" warning as antidepressants about increased risk of suicidal thinking and behavior in children, adolescents, and young adults.
Savella will get a medication guide outlining its risks. And the FDA is requiring postmarketing studies of the pregnancy and fetal outcomes in women who take Savella while pregnant, and a clinical trial of Savella's effects on babies exposed to the drug from breastfeeding.
Other FDA-approved fibromyalgia drugs include the nerve pain drug Lyrica and the SNRI antidepressant Cymbalta. Other antidepressants may be used to treat fibromyalgia but aren't specifically approved by the FDA for that use.
SOURCES:FDA: "Approval History, NDA 022256."News release, Forest Laboratories and Cypress Bioscience.
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