Cumberland Pharmaceuticals Inc. (CPIX), a specialty pharmaceutical firm, announced on Tuesday that the FDA has approved its supplemental New Drug Application. This approval is for a new, streamlined dosing regimen for Acetadote. Acetadote is utilized in hospital emergency rooms to prevent or reduce liver damage following an overdose of acetaminophen. Overuse of common over-the-counter pain and fever medications often results in such overdoses, leading to severe liver damage annually, whether accidental or intentional.
The traditional administration of Acetadote involves a dose of 300 mg/kg delivered intravenously in three distinct doses within 8 to 10 hours of ingesting a potentially harmful amount of acetaminophen. The newly approved regimen simplifies this process by merging the first two doses into a single, slower infusion.
Rick Dart, Director at the Rocky Mountain Poison and Drug Center, remarked, "This simplified dosing regimen is a valuable tool for healthcare providers in managing this potentially life-threatening condition."
On Monday, CPIX shares closed at $1.24, marking an increase of 0.40%. In after-hours trading, the stock surged 56%, reaching $1.94.
