Innovative Drug Reduces Fibromyalgia Pain

Lyrica (pregabalin) is the first drug to treat fibromyalgia (a disorder characterized by pain, fatigue and sleep problems) approved by the U.S. Food and Drug Administration (FDA, Rockville, MD, USA).

Lyrica reduces pain and improves daily functions for some patients with fibromyalgia, a disease in which the patient typically experiences long-lasting or chronic pain, as well as muscle stiffness and tenderness. Studies have shown that such patients have decreased pain after taking Lyrica, but the mechanism by which the drug produces such an effect is unknown. Two double blind, controlled clinical trials involving about 1,800 patients, supported the approval for use in treating fibromyalgia with doses of 300 milligrams or 450 milligrams per day.

The most common side effects of Lyrica include mild-to-moderate dizziness and sleepiness, blurred vision, weight gain, dry mouth, and swelling of the hands and feet. The side effects appeared to be dose-related. Lyrica can also impair motor function and cause problems with concentration and attention. Lyrica is a product of Pfizer (New York, NY, USA), and has previously been approved for treating partial seizures, pain following the rash of shingles and pain associated with diabetes nerve damage (diabetic neuropathy).

Today's new approval marks an important advance, and provides a reason for optimism for the many patients who will receive pain relief with Lyrica, said Steven Galson, M.D., M.P.H., director of the FDA's center for drug evaluation and research. However, consumers should understand that some patients did not experience benefit in clinical trials. We still have more progress to make for treatment of this disorder.

Fibromyalgia mostly affects women and typically develops in early-to-middle adulthood. Doctors make a diagnosis by conducting physical examinations, evaluating symptoms, and ruling out other conditions, since there is no test available for unequivocal diagnosis.


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U.S. Food and Drug Administration
Pfizer