Last updated: Apr 15, 2008
In 2007, Pfizer's Lyrica was 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.

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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.'"

Patients finding relief
Carolyn Bishop, 39, of San Antonio, Texas, had suffered with painful and sometimes debilitating symptoms related to fibromyalgia for more than 20 years. After being ignored by doctors (and even told at one point that her symptoms could not be differentiated from "laziness"), Bishop finally sought out a clinical trial for Lyrica. She was diagnosed with fibromyalgia and began taking the drug as part of the study. As the dosage increased, Bishop felt relief. But when she was switched to a lower-dose or a placebo, she says her symptoms returned in full force. So Bishop quit the study and began taking Lyrica off-label.

"I was able to go from being a lump on the sofa to going back to school full time, taking care of my kids, traveling with my husband, and going to the movies," says Bishop, who now takes 600 mg daily (150 mg over the approved dose of 450 for treating fibromyalgia). Bishop initially experienced dizziness as a side effect, but it went away. Her daughter, who was diagnosed with fibromyalgia at the age of 12, takes 450 mg and is unable to increase that amount or she experiences nausea and vomiting. She needs to supplement the Lyrica with naproxen for pain in her knees.

How dosing works
Because patients can experience side effects like dizziness and sleepiness, Charles E. Argoff, MD, director of the Comprehensive Pain Program at Albany Medical Center, in Albany, N.Y., recommends that patients begin with the lowest dose possible (75 mg twice a day). "You don't want to start high," says Dr. Argoff, "because the side effects might lead people to abandon treatment."

Dr. Argoff (who serves as a paid consultant to Pfizer) has seen improvement in his patients who take Lyrica, but also advises that treatment is a trial-and-error process and the drug may not bring relief to every patient. Dr. Argoff says patients do not appear to develop a tolerance to Lyrica that requires dosage increases, and he also views the therapy as an opioid-sparing treatment. "I believe Lyrica enables me to lower my use of opioids for people in chronic pain," he says.