Lyrica May Help Ease Fibromyalgia Pain

May 23, 2007 – The nerve-pain drug Lyrica reduces the pain, insomnia, and general dysfunction suffered by fibromyalgia patients, new studies show.

The studies included large numbers of patients with carefully diagnosed fibromyalgia. Fibromyalgia is a chronic pain disorder associated with fatigue, insomnia, depression, anxiety, exercise intolerance, and other complex symptoms.

Lyrica is approved by the FDA for the treatment of nerve pain caused by shingles and by diabetes. The drug also reduces some forms of epileptic seizures.

The new findings support Pfizer's FDA application to make Lyrica the first drug specifically approved for fibromyalgia treatment.

Some doctors already are prescribing the drug for their fibromyalgia patients, says Roland Staud, MD, director of the musculoskeletal pain research center at the University of Florida, Gainesville. Staud was one of the investigators participating in the studies of Lyrica.

"This is one of the most effective medications we currently have for fibromyalgia," Staud tells WebMD. "And this is one of the largest clinical trials ever for fibromyalgia -- that is what makes it really special."

Lyrica Halves Fibromyalgia Pain

At this week's meeting of the American Psychiatric Association (APA), University of Kentucky researcher Leslie J. Crofford reported results from a study of 1,051 fibromyalgia patients.

In the first phase of the Crofford study, all patients got Lyrica in daily doses ranging from 300 milligrams to 600 milligrams for six weeks; 85% of these patients responded to treatment with at least a 50% reduction in their fibromyalgia pain.

These "responders" then entered the second phase of the study, in which half continued to receive Lyrica and half were switched to identical-looking, inactive placebo pills.

More than 60% of the patients taking Lyrica, but only 32% of the patients switched to placebo had continued pain relief for at least 26 weeks. Lyrica-treated patients also reported that they slept better and felt better overall.

Another report at the APA conference came from Lesley M. Arnold, MD, director of women's health research at the University of Cincinnati. Arnold and colleagues studied 745 fibromyalgia patients given different doses of Lyrica or placebo.

"We demonstrated that Lyrica improved the broader management of fibromyalgia," Arnold tells WebMD. "It not only improves pain but has a positive impact on how patients feel overall."

Like Staud, Arnold has already been treating fibromyalgia patients with Lyrica.

"One of the nicest things about it is it reduces pain, number one," she says. "And it has a very positive effect on sleep -- which is welcome, as 70% to 90% of fibromyalgia patients have insomnia. They wake up more refreshed and feel better able to function during the day. That is a very positive effect, as most patients have severe social and occupational dysfunction because they feel tired during the day."

Side effects of Lyrica include drowsiness and dizziness, although Arnold says most patients get over these side effects in the first weeks of treatment.

A more insidious side effect is weight gain, Stroud says.

"What concerns me more is the weight gain patients have when taking Lyrica -- they just eat more," he says. "Patients have to watch their diet very carefully and do careful countermeasures to avoid excessive weight."

New Treatment, New Respect for Patients

Even though she spent two and a half years in bed, Lynne Kennedy Matallana didn't take her fibromyalgia lying down. When she finally got a correct diagnosis, she organized the National Fibromyalgia Association, for which she now serves as president.

Fibromyalgia is a disease with many symptoms but few physical signs. At first, many doctors doubted that it was a real physical illness at all. Since many patients with fibromyalgia become depressed, early treatment focused on patients' mental symptoms and not on their chronic pain.

Matallana, like many fibromyalgia patients, had a hard time getting her doctors to take her illness seriously. That's why FDA approval of Lyrica would mean more to her than just having a new treatment.

"When the FDA approves this, my pain will become real. Until then everyone questions it," Matallana tells WebMD. "A lot of research shows fibromyalgia is a very real and disabling disorder. But only when there is a fibromyalgia medication on the market will fibromyalgia have attention and legitimacy."

Stroud and Arnold say they're very excited about the Lyrica results. But they stress that the treatment is not a cure.

"Not everyone with fibromyalgia is going to respond to or tolerate Lyrica," Arnold says. "But even if patients have a response to the drug, it is important that their medication be part of an overall treatment plan that includes not just taking a pill but paying attention to their overall health habits, adding exercise once they feel better, and trying to reduce stress in their lives."

Nobody knows this better than Matallana.

"I feel there are many things you can do to pull that pain sensitization down," she says. "Good sleep hygiene is important. So is exercise -- but do it carefully and cautiously. Maybe just stretch in your bed at first, then walk very slowly, then work up to aerobic stuff. From being stuck in bed to where I could say, 'Yes, I can be at that appointment tomorrow' took me seven years. It was a journey of doing yoga, of doing water therapy, of finding out what I could and could not do."