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Pfizer Inc. (PFE) Injectable COX-2 Not Approvable



10/19/2005 5:12:17 PM

NEW YORK, Sept. 20 /PRNewswire-FirstCall/ -- 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.

Photo: A free corporate logo to accompany this story is availableimmediately via Wieck Photo Database to any media with telephoto receiveror electronic darkroom, PC or Macintosh, that can accept overheadtransmissions. To retrieve a logo, please call 972-392-0888.//Company News On-Call: http://www.prnewswire.com/comp/688250.htmlPfizer Inc

CONTACT: Mariann Caprino, of Pfizer Inc, +1-212-733-4554


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