NewsPfizer to fund safety study of Celebrex
12/14/05 - newratings.com
NEW YORK, December 14 (newratings.com) – Pharmaceutical giant Pfizer Inc (PFE) plans to finance a study of 20,000 patients to determine the potential heart risk of its cox-2 painkiller, Celebrex.
The international study is to be conducted by the Cleveland Clinic. Dr Steven E Nissen, a cardiologist at the Cleveland Clinic, will head the study, which will be called PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety versus Ibuprofen or Naproxen). Dr Nissen, who has served on the FDA panel, said that a study of this magnitude could cost the company more than $100 million. The Cleveland Clinic said in a statement on Tuesday that the study would also examine whether generic pain drugs naproxen and ibuprofen raise the risk of heart attacks, strokes and deaths.
There has been growing concern regarding drug safety following Merck’s withdrawal of its cox-2 painkiller, Vioxx, in September last year, after a study linked the arthritis drug to increased risks of heart attacks and strokes. Pfizer has witnessed a strong y/y decline in the sales of Celebrex, also known as celecoxib, for the first nine months of this year.
Pfizer had announced in October last year, only weeks after Merck’s withdrawal of Vioxx , that it planned to undertake a long-term study to prove Celebrex's safety.