Fibromyalgia

Drug name: Lyrica (pregabalin)

Manufactured by: Pfizer Inc.

Approval date: June 21, 2007

Approved for:

Lyrica is approved for treating fibromyalgia in adults who are 18 years and older. Pfizer has agreed to perform a study of the drug in children with fibromyalgia and a study in breastfeeding women.

How it works:

Lyrica reduces pain and improves function in patients with fibromyalgia. The mechanism of action is unknown, but there is some data suggesting that it has effects on the release of neurotransmitters in the brain. Neurotransmitters are chemicals in the brain that transmit signals from one neuron to another. People with fibromyalgia experience pain differently than people who don't have the condition. Treatment with Lyrica reduces the level of pain in some patients.

After meeting on the Internet in 1997, Lynne Matallana and Karen Lee Richards discovered they had a lot in common. They both had seen numerous doctors before being diagnosed with fibromyalgia, a chronic condition characterized by fatigue and widespread pain in muscles and joints. They both had trouble finding medical information and support for coping with the illness. Seven months after meeting, they started gathering with five other people with fibromyalgia who also wanted to bring awareness to the issue.

The U.S. Food and Drug Administration today approved Lyrica (pregabalin), the first drug to treat fibromyalgia, a disorder characterized by pain, fatigue and sleep problems.

Lyrica reduces pain and improves daily functions for some patients with fibromyalgia.

"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," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research. "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."

New research supported by the National Institutes of Health’s National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) shows that the anticonvulsant medication gabapentin, which is used for certain types of seizures, can be an effective treatment for the pain and other symptoms associated with the common, often hard-to-treat chronic pain disorder, fibromyalgia.

In the NIAMS-sponsored, randomized, double-blind clinical trial of 150 women (90 percent) and men with the condition, Lesley M. Arnold, M.D., director of the Women’s Health Research Program at the University of Cincinnati College of Medicine, and her colleagues found that those taking gabapentin at dosages of 1,200 to 2,400 mg daily for 12 weeks displayed significantly less pain than those taking placebo. Patients taking gabapentin also reported significantly better sleep and less fatigue. For the majority of participants, the drug was well tolerated. The most common side effects included dizziness and sedation, which were mild to moderate in severity in most cases.

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