Cumberland Pharmaceuticals Inc. (CPIX), a specialty pharmaceutical company, Tuesday, announced that its supplemental New Drug Application seeking approval for a new simplified dosing regimen for Acetadote has been given the FDA nod.
Acetadote is used in hospital emergency departments to prevent or lessen the risk of liver damage following an acetaminophen overdose, which is often caused by overuse of over-the-counter pain relief and fever-reducing products.
Every year, accidental or intentional acetaminophen poisoning leads to serious liver damage.
The standard dosing regimen of Acetadote is 300 mg/kg, administered intravenously in 3 separate, sequential doses within 8 to 10 hours after ingestion of a potentially hepatotoxic quantity of acetaminophen.
The newly approved dosing regimen simplifies the administration of Acetadote by combining the first two doses of the standard regimen into a single, slower infusion, according to the company.
Rick Dart, Director at the Rocky Mountain Poison and Drug Center said, "This simplified dosing regimen is a valuable tool for health care providers in managing this potentially life-threatening condition."
CPIX closed Monday's trading at $1.24, up 0.40%. In after-hours, the stock was up 56% at $1.94.
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