Lyrica: What You Need to Know About the First Drug Approved to Treat Fibromyalgia

There is no magic bullet for fibromyalgia, but sufferers have access now to a drug approved in 2007 by the Food and Drug Administration to treat the pain of this syndrome: Pfizer's Lyrica (pregabalin), a medication previously approved to treat diabetic nerve damage, pain from shingles, and partial seizures.

The FDA based approval on two double-blind studies, involving a total of 1,800 patients, which showed decreased pain after use of doses ranging from 300 to 450 mg a day. How exactly the drug works is not understood, although it's believed that it calms down hyperactive neurons and could affect the release of neurotransmitters, which are chemicals in the brain that transmit signals from one neuron to another. Not all patients see benefits.

Studies showed help with pain and sleep
One multicenter double-blind study, published in 2005 in the journal Arthritis & Rheumatism, found that Lyrica reduced symptoms of pain, disturbed sleep and fatigue, and that the drug was "generally well-tolerated," with the most frequent side effects being dizziness and sleepiness.

"I've used a lot of other kinds of medicines in my practice and this works," says Leslie J. Crofford, MD, chief of the Division of Rheumatology and Women's Health at the University of Kentucky Academic Medical Center, in Lexington, Ky. "For many, many patients it works better than anything that they've ever tried."

Dr. Crofford had been pressing for clinical trials to be done on the drug ever since her days at the University of Michigan in the '90s when she and her colleagues noted anecdotal reports that an older version of the drug seemed to provide their patients some relief. Initially, she says, pharmaceutical companies were reluctant to dive into the fibromyalgia challenge.

"None of the pharmaceutical companies thought that we could treat fibromyalgia. They were just like 'Oh these patients are just complaining. They can't get better. We can't create a drug for these patients.'"

Pfizer did conduct large-scale clinical trials, however, and FDA approval followed. Dr. Crofford feels Lyrica not only expands treatment options but further validates fibromyalgia itself.

"Doctors don't want to diagnose a condition that they can't treat. So once we have a condition that we can treat, you can make the diagnosis earlier. So patients don't have to suffer for years with everybody telling them they're crazy, it's all in their head: 'Your lab tests are normal. Your X-rays are fine. There's nothing wrong with you.'"