On Monday, the FDA approved Cumberland Pharmaceuticals Inc’s (NASDAQ:CPIX) supplemental New Drug Application (sNDA) for its Acetadote (N-acetylcysteine for injection) product.

Acetadote is an intravenous (IV) formulation of N-acetylcysteine (NAC) indicated to prevent or lessen liver injury after ingestion of potentially toxic quantities of acetaminophen.

Acetaminophen, a common over-the-counter pain reliever and fever reducer, is the leading cause of acute liver failure in the United States.

Each year, thousands of individuals experience accidental or intentional acetaminophen poisoning, leading to serious liver damage.

The newly approved dosing regimen simplifies the administration of Acetadote by combining the first two bags of the standard regimen into a single, slower infusion.

This streamlined approach has been implemented in hospitals across multiple countries. It has been demonstrated to reduce the frequency of medication errors and potentially serious non-allergic anaphylactoid reactions (NAARs) without compromising the effectiveness of Acetadote.

By simplifying the dosing regimen, healthcare providers can administer the life-saving treatment more efficiently, potentially improving patient outcomes.

For the third quarter, Cumberland Pharmaceuticals reported net revenues of $9.1 million, down from $10.1 million a year ago.

Last month, the FDA granted Orphan Drug Designation and Rare Pediatric Disease Designation to Ifetroban for cardiomyopathy associated with Duchenne muscular dystrophy (DMD). 

Cumberland is completing the FIGHT DMD Phase 2 trial investigating the pharmacokinetics, safety, and efficacy of once daily oral Ifetroban in patients with DMD. Results will be announced later this year.

Price Action: CPIX stock is up 142.7% at $3.01 at the last check on Tuesday.

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