NEWS: FDA rejects parecoxib, only injectable COX-2 inhibitor

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FDA rejects parecoxib, only injectable COX-2 inhibitor



Sep 20, 2005



Gandey

New York, NY - Pfizer announced today that it received a letter from

the US Food and Drug Administration alerting it that its injectable

COX-2 selective agent is " nonapprovable. " The product, parecoxib

sodium (Dynastat), is currently available in Europe and is indicated

for short-term treatment of postoperative pain. This is not the first

time the FDA has rejected parecoxib and, as previously reported by

rheumawire, the agency issued its first nonapprovable letter in 2001

to Pharmaciathe drug developer at the time. Pfizer had been

comarketing the product during this period but has since acquired

Pharmacia. The FDA declined a request for comment about the decision.



As the only injectable COX-2 specific inhibitor, parecoxib sodium

provides an important option in the treatment of acute pain in the

postsurgical setting.



In a news release addressing the issue, company officials said they

plan to meet with the FDA to discuss the concerns. Pfizer points out

that parecoxib sodiumalong with many other COX-2 inhibitorswas

recently reviewed at length by the European Agency for the Evaluation

of Medicinal Products (EMEA) and considered to have a favorable

benefit-to-risk profile.

But this prodrug to valdecoxib has many critics

Parecoxib sodium, however, is a prodrug to another Pfizer product

valdecoxib (Bextra)and that COX-2 inhibitor has received frosty

reviews internationally. In April, European, American, and Canadian

regulators urged Pfizer to withdraw the product due to a lack of

adequate safety data and an absence of demonstrated advantages

compared with other nonsteroidal anti-inflammatory drugs.

Earlier this year at an FDA advisory meeting examining the benefits

and risks of NSAIDs, panelists offered harsh criticism about

valdecoxib. As previously reported by rheumawire, committee members

questioned whether the product should have ever been approved at all

considering the " paucity of data " and the additional concern over

adverse skin reactions. Dr Curt Furberg (Wake Forest University,

Winston-Salem, NC) said that in the absence of strong evidence, the

committees needed to reconsider whether valdecoxib should remain on

the market. " Perhaps we have to face up to this and take it off the

market, " he said at the meeting.

But Pfizer counters that the new prodrug to valdecoxib has been shown

to reduce the need for opioids to control pain following surgery. The

company told reporters, " As the only injectable COX-2 specific

inhibitor, parecoxib sodium provides physicians and patients with an

important option in the treatment of acute pain in the postsurgical

setting. "

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