King initiates pivotal Ph III US Vanquix trial

The USA's King Pharmaceuticals has started a pivotal Phase III clinical trial evaluating its investigational drug Vanquix (diazepam administered using King's auto-injector technology) as a treatment for acute, repetitive seizures associated with epilepsy.

While the US Food and Drug Administration has not yet evaluated the safety or efficacy of the agent, the firm hopes the drug will become the first commercially-available adjunctive injectable therapy, outside of a hospital setting, for the emergency treatment of this condition. At present, the only product commonly used in this context is a diazepam rectal gel and Vanquix is designed to provide a superior means of delivering the active agent to such patients.

Currently-marketed products utilizing King's auto-injector technology include EpiPen (epinephrine), which King describes as the "definitive emergency treatment" for severe anaphylaxis.