FDA approves first ever drug for Fibromyalgia (FMS): Lyrica offers new hope to sufferers of chronic pain.

There was some good news today from the U.S. Food and Drug Administration (FDA). It approved the first ever drug specifically to treat fibromyagalia. The drug is called Lyrica and could improve  the quality of life for six million Americans  suffering from chronic pain and the disabling disease of fibromyalgalia.

Fibromyalgia, chronic pain and depression often are related illnesses. Chronic pain has a direct effect on mood and can exacerbate depression.

Lyrica reduces pain and improves daily functions for some patients with fibromyalgia, notes the FDA.

"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," says the FDA's Steven Galson, MD, MPH, in an FDA news release.

"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," says Galson, who directs the FDA's Center for Drug Evaluation and Research.

People with fibromyalgia (FMS) have been shown to experience pain differently from other people. Studies have shown that such patients have decreased pain after taking Lyrica, but the mechanism by which Lyrica produces such an effect is unknown.

The FDA approved Lyrica for the treatment of fibromyalgia based on two clinical trials that included about 1,800 fibromyalgia patients. The trials backed Lyrica's use in treating fibromyalgia at doses of 300 milligrams or 450 milligrams per day, according to the FDA.

Lyrica is already 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

Lyrica's side effects

In Lyrica's clinical trials for fibromyalgia treatment, the drug's most common side effects included mild to moderate dizziness and sleepiness.  Blurred vision, weight gain, dry mouth, and swelling of the hands and feet also were also reported in the clinical trials.

“This is an important day for people with fibromyalgia (FMS) and a real opportunity to help physicians effectively manage this disorder,” said Dr. Don Goldenberg, M.D., co-chair of the fibromyalgia guideline panel for the American Pain Society and professor of medicine, Tufts University. "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."

Side effects appeared to correlate with the drug's dose, notes the FDA.

Lyrica can impair motor function and cause problems with concentration and attention. The FDA advises patients to talk to their doctor or other health care professional about whether the use of Lyrica may impair their ability to drive.