Parecoxib. Pharmacia corp.
Pharmacia (formerly Monsanto) is developing parecoxib, an injectable COX-2 inhibitor, for the management of post-surgical acute pain [287279], [313957]. By January 1999, the compound was in phase III trials for this indication [312280]. In October 2000, Pharmacia submitted an NDA for parecoxib sodium for the management of acute pain to the FDA. The company anticipated a 12-month review of the NDA [387654] but received a 'not approvable' letter in July 2001, indicating there were deficiencies in the filing; at this time, Pharmacia anticipated refiling before the end of 2002 [415668]. Under a license agreement with Pharmacia Corp, parecoxib (designated YM-177) is being developed in Japan by Yamanouchi [392030]. Prior to the FDA ruling, in June 2000, the company anticipated that the compound would be launched by 2001 [370466]. In March 2000, Merrill Lynch predicted that parecoxib would be filed in the third quarter of 2000 [361969], [382577]. By May 2001, the analysts revised their predictions to launch in 2002 [411811].
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Professor Emeritus of Anesthesiology, State University of New York, Downstate Medical Center, New York, NY, USA.