INNOVATION:  Researchers at UCLA have discovered that hepatotoxicity of APAP can be reduced by co-administration of another compound. This other compound has been used as a research tool and it is currently being tested in clinical trials for an unrelated indication. This invention therefore encompasses a method for reducing hepatotoxicity of APAP as well as a specific formulation of APAP with another compound. The mechanism of action of the added compound is well understood. This compound activates a pathway that prevents the in vivo formation of a toxic metabolites and causes the downregulation of a key enzymes in the metabolism pathway.

This combination therapy of APAP and the compound has been demonstrated to reduce APAP-hepatotoxicity related death in mice, both from APAP alone and when APAP toxicity is potentiated by other drugs and alcohol. Furthermore, this combination therapy prevents APAP induction as evaluated by liver toxicity assays as well as liver damage histological sections.

ADVANTAGES

• A safer formulation of APAP that may reduce toxicity in humans.
• A safer formulation that decreases mortality
• A new combination therapy that increases the efficacy of APAP that may become be the dominant therapy thereby increasing consumer confidence
• Patent protection in the acetaminophen market

Reference: UCLA Case No. 2006-095