Gufic Biosciences receives TGA Australia and ANVISA Brazil approval for Parecoxib 40mg injection
Drug Approval

Gufic Biosciences receives TGA Australia and ANVISA Brazil approval for Parecoxib 40mg injection

Parecoxib Sodium is the first parenteral selective COX-2 inhibitor available for clinical use in pain management

  • By IPP Bureau | September 12, 2023

Gufic Biosciences Limited (Gufic) have received approval from the Therapeutic Group Administration (TGA), Australia and the National Health Surveillance Agency (ANVISA), Brazil for Parecoxib Sodium 40mg Lyophilized Powder for Injection, a selective COX-2 inhibitor, which shall be used for short-term treatment of acute pain and post-operative pain in adult patients.

Gufic has been persistently committed to saving and improving lives of patients across the globe with its continuous efforts through the international regulatory agencies to bring novel molecules for the mankind.

Parecoxib Sodium is the first parenteral selective COX-2 inhibitor available for clinical use in pain management. Selective COX-2 inhibitors were developed to avoid the gastrointestinal side effects related to COX-1 inhibitors. Parecoxib is a prodrug of a sulphonamide based COX-2 inhibitor, Valdecoxib, a potent anti-inflammatory and analgesic drug. Following a single Intravenous (IV) or Intramuscular (IM) dose, Parecoxib is rapidly converted to Valdecoxib by enzymatic hydrolysis in Liver.

Parecoxib's first perceptible analgesic effect occurs within seven to thirteen minutes, with a peak effect within two hours following administration of single dose of 40mg injection by IV or IM route.

Parecoxib has more potent synergistic effects when combined with morphine than other COX-2 NSAIDs and reduces the amount of opioid needed for adequate analgesia. This overall reduction in opioid drug improves the safety margin of the analgesic regime and provides better analgesic coverage.

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