Celebrex celecoxib: NDA under review; marketed to treat osteoarthritis and pain

In a 77-patient Phase III trial, 400 mg Celebrex taken twice per day for 6 months reduced the number and size of colorectal polyps in patients with FAP compared to placebo (p=0.003 and p=0.055), respectively, and fewer Celebrex patients experienced an increase in the number of polyps than in the placebo group. In the Celebrex group, 53 percent of patients had a ?25 percent reduction in polyp number compared to 7 percent of patients on placebo (p=0.003).

Separately, researchers presented data from 5,155 patients taking Celebrex for up to 2 years, showing an incidence of upper gastrointestinal (GI) tract side effects of 0.18 percent per year, compared to historical rates of 1.3-1.9 percent per year with conventional marketed NSAIDs. ...