The U.S. Food and Drug Administration has approved Lyrica (pregabalin), the first drug to treat fibromyalgia, a disorder characterized by pain, fatigue and sleep problems.
Lyrica reduces pain and improves daily functions for some patients with fibromyalgia.
"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 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."
Persons with fibromyalgia typically experience long-lasting or chronic pain, as well as muscle stiffness and tenderness. Fibromyalgia affects about 3 million to 6 million people in the United States each year. The disorder mostly affects women and typically develops in early-to-middle adulthood.
There is no test for the diagnosis of fibromyalgia Doctors make a diagnosis by conducting physical examinations, evaluating symptoms, and ruling out other conditions.
Individuals with fibromyalgia have been shown to experience pain differently from other people. Studies have shown that such patients have decreased pain after taking Lyrica, but, the mechanism by which Lyrica produces such an effect is unknown.