Pharmacia files for follow-up COX-2 OK

Pharmacia has submitted a New Drug Application for valdecoxib, itsfollow-up to Celebrex (celecoxib), for the treatment of acute pain, dysmenorrhea, osteoarthritis and rheumatoid arthritis, to the US Food and Drug Administration.

Like Celebrex, valdecoxib is an oral COX-2 inhibitor, co-developed by Pharmacia and Pfizer, and is the third drug to emerge from Pharmacia's COX-2 research program. An injectable inhibitor, parecoxib sodium (which is a prodrug of valdecoxib), is under review by the FDA for the management of pain in acute care settings.

Pharmacia has previously reported that valdecoxib offers a rapid onset of activity compared to Celebrex, as well as prolonged efficacy, with once-a-day dosing (Marketletter December 18, 2000). It is expecting a standard 12-month review period for the new drug at the FDA.