FDA OKs Cymbalta for Fibromyalgia

June 16, 2008 -- The FDA has approved the drug Cymbalta to treat fibromyalgia.

That makes Cymbalta the first antidepressant approved to treat fibromyalgia, which is a chronic disorder of the muscles and related soft tissue, including ligaments and tendons. Its main symptoms are muscle pain, fatigue, sleep disturbances, and tender points at certain points of the body.

Besides fibromyalgia and depression, Cymbalta is also approved to treat generalized anxiety disorder and diabetic peripheral neuropathic pain, a diabetes-related pain condition, in adults.

Cymbalta belongs to a class of drugs called serotonin and norepinephrine reuptake inhibitors (SNRIs).

The FDA approved Cymbalta for fibromyalgia based on two clinical trials that together included 874 fibromyalgia patients, according to Lilly.

For three months, the patients either took Cymbalta or a placebo. Cymbalta trumped the placebo at pain reduction and overall improvement.

Compared to patients taking the placebo, Cymbalta patients were more likely to experience nausea, dry mouth, constipation, decreased appetite, sleepiness, increased sweating, and agitation.

Cymbalta is the second drug approved by the FDA to treat fibromyalgia. Nearly a year ago, the FDA approved Lyrica as the first drug treatment for fibromyalgia. Lyrica also treats nerve pain caused by shingles and diabetes, as well as reducing some forms of epileptic seizures.