מתוך medicontext.co.il
By Ori Twersky
WASHINGTON (Reuters Health) – Pharmaceutical makers Pharmacia Corp. and Pfizer Inc. jointly announced on Monday that Pharmacia has received approval from the US Food and Drug Administration (FDA) to market a new Cox-2 inhibitor, offering a once-a-day treatment regimen for osteoarthritis.
The companies said that Pharmacia received approval for Bextra (valdecoxib tablets), a Cox-2 inhibitor that would also be indicated for the treatment of adult rheumatoid arthritis and for menstrual pain.
Pfizer is Pharmacia's co-promotion partner.
The companies said that the approval of Bextra was based upon global clinical trials, involving more than 5,000 patients. In those clinical trials, the companies said that the 10 mg tablet of Bextra taken once daily was shown to be as effective as the commonly prescribed doses of other NSAIDs, including ibuprofen, diclofenac and naproxen for the treatment of osteoarthritis.
Pharmacia spokesman Craig Buchholtz told Reuters Health that the exact launch date and price per dose had yet to be determined.
Merrill Lynch securities analyst Steven Tighe said that he expects 2002 sales of Bextra to generate about $450 million in revenues. Tighe said that these estimates were in part based upon the fact that the FDA approval was received ahead of schedule, giving the companies a jump on Merck's second generation Cox-2 inhibitor Arcoxia (etoricoxib).
Merck just filed for the approval of Arcoxia in the last couple of months.
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