Gufic Biosciences gets TGA, ANVISA nod for Parecoxib Sodium

Gufic Biosciences Limited (Gufic) has received regulatory approval from the Therapeutic Group Administration (TGA) in Australia and the National Health Surveillance Agency (ANVISA) in Brazil for Parecoxib Sodium 40mg Lyophilized Powder for Injection. This selective COX-2 inhibitor is approved for the short-term treatment of acute pain and post-operative pain in adult patients. The approval marks a significant milestone, as Parecoxib Sodium is the first parenteral selective COX-2 inhibitor available for clinical use in pain management.

Gufic Biosciences’ commitment to global health is evident through its ongoing efforts to secure international regulatory approval for novel molecules. The company aims to improve and save lives by offering advanced treatment options, such as Parecoxib Sodium, for pain management. This COX-2 inhibitor was specifically developed to minimize gastrointestinal side effects commonly associated with COX-1 inhibitors.

Parecoxib Sodium is a prodrug of Valdecoxib, a sulphonamide-based COX-2 inhibitor, which demonstrates potent anti-inflammatory and analgesic effects. Upon administration, either by intravenous (IV) or intramuscular (IM) methods, Parecoxib is rapidly converted to Valdecoxib by enzymatic hydrolysis in the liver. The drug shows its first perceptible analgesic effects within seven to thirteen minutes and reaches peak effect within two hours after a single 40mg dose.

The advantages of Parecoxib Sodium extend beyond its rapid onset of action. The drug has shown to have more potent synergistic effects when used in combination with morphine, as compared to other COX-2 nonsteroidal anti-inflammatory drugs (NSAIDs). This synergistic effect reduces the overall amount of opioid medication needed for adequate analgesia. By doing so, Parecoxib Sodium improves the safety margin of the analgesic regime and provides better analgesic coverage.

The approval of Parecoxib Sodium by TGA Australia and ANVISA Brazil is a significant achievement for Gufic Biosciences, further solidifying its commitment to offering innovative and effective treatments for pain management in adult patients.