FDA approves fibromyalgia drug

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Well, I guess at least it's good to know that FMS is starting to be taken seriously as a real illness, even if they don't know what it is. http://online.wsj.com/article/SB118245956340043894.html?mod=googlenews_wsj FDA Approves Pfizer's LyricaFor Treatment of Fibromyalgia By JENNIFER CORBETT DOORENJune 21, 2007 5:16 p.m. WASHINGTON -- The U.S. Food and Drug Administration on Thursday approved Pfizer Inc.'s Lyrica to treat fibromyalgia, a poorly understood pain disorder. The approval marks the first time a drug has been approved for fibromyalgia, which is believed to affect three to six million Americans, mostly women. Fibromyalgia is marked by widespread muscle pain, tenderness and fatigue. The condition traditionally has been treated with a mix of painkillers and antidepressants. Lyrica, already on the market to treat nerve pain associated with diabetes and shingles, is designed to interfere with damaged nerves that cause pain. The drug had $1.2 billion in world-wide sales last year, and has been used by about five million people. The FDA granted Lyrica priority review status, which cuts four months off the standard 10-month drug review time and is reserved for

treatments the agency deems an advance over existing therapies on the market. The approval was good news for Pfizer, which on Wednesday saw the FDA delay approval of its proposed HIV drug maraviroc. Pfizer also announced Wednesday it had ended development of a lung cancer compound, PF-3512676 for lack of effectiveness. Romano, a vice president in Pfizer's global medical division, said Lyrica appears to "dampen" the hyperexcitability of the central nervous system. The FDA said 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 Galson, the director of FDA's Center for Drug Evaluation and Research. However, he cautioned that not everyone on the clinical studies experience a benefit

from Lyrica. The FDA said two studies involving about 1,800 patients, support approval for use in treating fibromyalgia with doses of 300 milligrams or 450 milligrams per day. Pfizer had also studied a higher 600-milligram dose for Lyrica. One of the studies involving Lyrica lasted about three months and involved about 750 patients who were assigned to a 600-milligram, 450-milligram or 300-milligram dose of Lyrica or a placebo. It showed that 30% of patients on the highest dose had a 50% or more reduction in pain, as measured by a commonly used index, compared with 27% on the middle dose, 24% at the lowest dose and 15% on placebo, or a fake pill. The most common side effects of Lyrica included dizziness and sleepiness. Blurred vision, weight gain, dry mouth, and swelling of the hands and feet also were reported in clinical trials, and the FDA said side effects appeared to be dose related. The FDA said Pfizer has agreed to study Lyrica in children with fibromyalgia as well as a study in breastfeeding women. Write to Corbett Dooren at jennifer.corbett-dooren@...