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Parecoxib. Pharmacia corp.

A W Gotta1

  • 1Professor Emeritus of Anesthesiology, State University of New York, Downstate Medical Center, New York, NY, USA.

Idrugs : the Investigational Drugs Journal
|June 24, 2005
PubMed
Summary
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Parecoxib, an injectable COX-2 inhibitor, was developed for post-surgical pain. Despite initial trials and FDA submission, it faced approvability issues, delaying its market entry.

Area of Science:

  • Pharmacology
  • Drug Development
  • Pain Management

Background:

  • Parecoxib is an injectable selective cyclooxygenase-2 (COX-2) inhibitor.
  • It was developed by Pharmacia (formerly Monsanto) for managing acute post-surgical pain.

Purpose of the Study:

  • To track the development and regulatory status of parecoxib for acute post-surgical pain management.
  • To document the timeline of clinical trials, regulatory submissions, and anticipated market launch.

Main Methods:

  • Review of clinical trial phases (Phase III by January 1999).
  • Monitoring of regulatory submissions to the U.S. Food and Drug Administration (FDA).
  • Analysis of company and analyst predictions regarding filing and launch dates.

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Main Results:

  • Pharmacia submitted an NDA for parecoxib sodium in October 2000.
  • The FDA issued a 'not approvable' letter in July 2001 due to filing deficiencies.
  • Development in Japan is underway by Yamanouchi under a license agreement.

Conclusions:

  • Parecoxib faced regulatory hurdles in the U.S. market.
  • Pharmacia aimed to refile the NDA before the end of 2002.
  • Market launch predictions were revised from 2001 to 2002.