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Treatment for Pain

Pfizer Receives FDA Non-Approvable Letter on Parecoxib

NEW YORK, September 20, 2005 -- Pfizer Inc said today it disagrees with the conclusions stated in a non-approvable letter it received from the U.S. Food and Drug Administration regarding parecoxib sodium, a non-narcotic injectable COX-2 selective analgesic for the treatment of acute pain. The company plans to meet with the FDA to discuss the agency's concerns.

Pfizer said parecoxib is widely available worldwide, including in the European Union, mostly under the brand name Dynastat.

As the only injectable COX-2 specific inhibitor, Dynastat provides physicians and patients with an important option in the treatment of acute pain in the post-surgical setting. Administered for short periods of time under the supervision of a healthcare professional, Dynastat has been shown to reduce the need for opioids to control pain following surgery.

Earlier this year the COX-2 class of pain medicines underwent an extensive review by the European Medicines Evaluation Agency. The agency concluded that, based on the overall safety data and with appropriate labeling, "the benefits (of Dynastat) continue to outweigh the risks." Further, many other regulatory agencies worldwide conducted similar reviews and arrived at a similar conclusion.

Posted: September 2005

Parecoxib FDA Approval History

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