June 22, 2007 - The US Food and Drug Administration (FDA) announced the approval yesterday of pregabalin (Lyrica, Pfizer) as a treatment for fibromyalgia. The drug is the first one to be approved for the treatment of this painful condition, and it has been shown to reduce pain and improve daily function for some patients.
"Today's new approval marks an important advance, and provides a reason for optimism for the many patients who will receive pain relief" with this drug, Steven Galson, MD, PhD, director of the 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."
Pregabalin is already approved for the treatment of partial seizures, pain following rash of shingles, and pain associated with diabetic neuropathy.
Fibromyalgia is estimated to affect up to 6 million people in the United States each year. It affects mostly women and typically develops in early to middle adulthood.
Approval of pregabalin for this indication was based on 2 randomized, controlled, double-blind studies presented at the recent American Academy of Neurology and American Psychiatric Association meetings. These results, in more than 1800 patients, "support approval for use in treating fibromyalgia with doses of 300 mg to 450 mg per day," the FDA statement notes.
The most common adverse effects in these studies were mild to moderate dizziness and sleepiness, the statement adds. Blurred vision, weight gain, dry mouth, and swelling in hands and feet were also reported in the clinical trials. Adverse effects appeared to be dose-related.
"Lyrica can impair motor function and cause problems with concentration and attention," the FDA statement pointed out. "FDA advises that patients talk to their doctor or other healthcare professional about whether use of Lyrica may impair their ability to drive."
Pfizer has agreed to conduct studies of pregabalin in children with fibromyalgia and in breast-feeding women, the FDA adds.
"This is an important day for people with fibromyalgia and a real opportunity to help physicians effectively manage this disorder," said Don Goldenberg, MD, cochair of the American Pain Society's fibromyalgia guideline panel and professor of medicine at Tufts University in Boston, Massachusetts, in a statement issued by Pfizer. "Having a medication approved for use in fibromyalgia, along with research advances, will go a long way to improving our understanding and treatment of this common disorder."