Fibromyalgia is a condition character- ized by at least 3 months of widespread pain (both above and below the waist and on both sides of the body) and by the presence of at least 11 tender points (these are the official American College of Rheumatology criteria). There are no diag- nostic tests for fibromyalgia, and it is a diagnosis of exclusion. Recently, the FDA announced approval for Lyrica (prega- balin, the “cousin” of Neurontin, or gabapentin) for the treatment of fibromyalgia, based on two double-blind placebo controlled trials involving 1800 patients. Effective doses ranged from 300 to 450 mg/day.

TCPR’s Take: We have not yet seen the data upon which the FDA’s approval was based, although a brief summary of some of this data is presented on the Pfizer website, in their updated Lyrica product insert (http://www.pfizer.com/ pfizer/download/uspi_lyrica.pdf). The key questions will be whether Lyrica does better than tricyclics or SNRIs, both of which are effective in fibromyalgia (though neither class has FDA approval). Lyrica has a fairly negative side effect profile, including high rates of sedation and dizziness, and has some abuse liability, being classified in the same DEA schedule as cough suppressants with codeine.