Pfizer drug gets U.S. approval to treat fibromyalgia

By Lisa Richwine

WASHINGTON (Reuters) - Pfizer Inc. won U.S. approval on Thursday to promote its prescription drug Lyrica for treating fibromyalgia, a chronic disease which can cause debilitating pain, sleep problems, stiffness and fatigue.

The medicine is the first treatment approved by the U.S. Food and Drug Administration for fibromyalgia, which affects about 3 million to 6 million people in the United States each year, mostly women, the FDA said.

Pfizer already sells Lyrica for treating neuropathic pain, a type of pain arising from the nerves without any obvious cause, and epileptic seizures.

The approval "provides a reason for optimism for the many patients who will receive pain relief with Lyrica," said Dr. Steven Galson, director of FDA's Center for Drug Evaluation and Research, in a statement.

"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," Galson said.

Promotion of the drug for fibromyalgia is expected to boost sales of Lyrica.

First-quarter Lyrica sales more than doubled to $395 million, Pfizer reported in April. The drug has been prescribed to more than 5 million people worldwide. Its generic name is pregabalin.

The cause of fibromyalgia is unknown, and no test exists to confirm a diagnosis. Doctors rely on patient complaints of symptoms and subjective responses to physical exams.