Searle/Pfizer Celebrex
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Enrollment begins for a three-year study in more than 1,000 patients to test safety and efficacy of celecoxib in reducing the occurrence of new, sporadic adenomatous polyps in the colon and rectum in patients with at least one previously removed polyp. The multicenter, randomized, double-blind, placebo-controlled trial will test patients with a history of, but not a familial disposition toward, adenomatous polyps, which "are a precursor to more than 95 percent of all colorectal cancers," according to the companies. In December, the COX-2 inhibitor was approved for treatment of patients with familial adenomatous polyposis. Celebrex also is indicated for use in osteoarthritis and rheumatoid arthritis