FRIDAY, June 22 (HealthDay News) -- The U.S. Food and Drug Administration has approved Lyrica (pregabalin) for the treatment of the chronic, widespread pain condition fibromyalgia. It is the first drug that has been approved for fibromyalgia, a condition thought to affect between 3 million and 6 million people in the United States each year.
The drug, manufactured by Pfizer Inc. in New York, N.Y., was already approved for treatment of partial seizures, shingles-related pain and diabetic neuropathy.
Approval was granted on the basis of two double-blind, placebo-controlled clinical studies of 1,800 patients with fibromyalgia. Compared with placebo, pregabalin produced rapid and sustained pain reduction for up to six months. Common side-effects include dizziness and sleepiness, while some patients also reported blurred vision, weight gain, dry mouth, and swollen hands and feet.
"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, 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."
More Information
