In the clinical trails of patients with fibromyalgia, those on pregabalin (Lyrica) had “rapid and sustained improvements in pain,” compared with those on placebo, and “reported feeling better and improvements in physical function,” according to a statement issued by Pfizer, which manufactures pregabalin.

The same statement explains that the drug’s mechanism of action for

Fibromyalgia is not known, but states that patients with fibromyalgia may be more sensitive that normal to stimuli that are not usually painful, and that pregabalin may reduce the degree of pain experienced by patients with fibromyalgia by binding to a specific protein within “overexcited nerve cells.”

The approval “marks an important advance, and provides a reason for optimism for the many patients who will receive pain relief” with pregabaldin, Dr. Steven Galson, the director of the FDA’s Center for Drug Evaluation and Research said in the FDA statement. He added, however, that consumers should

understand that some patients in trials did not benefit from the drug, and that “we still have more progress to make for treatment of this disorder.”

The most common side effects in the trial were mild to moderate dizziness and sleepiness; blurred vision, weight gain, dry mouth, and swelling of the hands and feet also were also reported. Side effects appeared to be dose related, according to the FDA. Patient should talk to their physicians or other health care providers about whether pregabalin – which can impair motor function, concentration, and attention – can affect their ability to drive, the FDA advised. Pfizer has agreed to conduct a study of pregabalin in children and another in women who are brest-feeding.

Pregabalin, a centrally acting drug, was first approved in 1984 for the management of neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia, and for the adjunctive therapy for adult patients with partial onset seizures. It is taken orally in capsule form.

Fibromyalgia affects about 3 million to 6 million people in the United States annually.

Ob.Gyn. News July 15, 200