Celebrex approved for pain indication in USA

Pharmacia's COX-2 inhibitor Celebrex (celecoxib) has been approved bythe US Food and Drug Administration for the treatment of acute pain and menstrual pain in adults, providing the drug with what its manufactu-rer claims is the broadest spectrum of indications for any drug in the class.

Importantly, this new indication provides patients with the benefit of being able to take an additional dose if needed for individualized relief of acute pain, said the firm. This will help the product in its battle with Merck & Co's rival COX-2 inhibitor Vioxx (rofecoxib), which is already approved for these pain indications. Celebrex' label now covers all the indications offered by the Merck drug, but with additional uses in rheumatoid arthritis and the reduction in familial adenomatous polyps, which can be a precursor to colorectal cancer.

Sales of Celebrex were $2.6 billion in 2000, compared to $2.2 billion for Vioxx in the same year, though Pharmacia's drug was launched six months earlier and benefits from a co-marketing deal with Pfizer. However, sales growth of both drugs has slowed in recent months, amid cardiovascular safety concerns and a reluctance by some physicians and insurers to stump up the premium pricing for the COX-2 inhibitors compared to older non-steroidal anti-inflammatory drugs. While still showing a 24% sales hike to $851 million in the third quarter of this year (see page 26), Celebrex' growth is well below that of previous quarters.