Eli Lilly and Co. received a not approvable letter from the FDA for Zyprexa long-acting injection (olanzapine LAI) for the treatment and maintenance of schizophrenia in adults. Zyprexa LAI is an investigational formulation that combines the antipsychotic medication Zyprexa (olanzapine) with a pamoate salt, for an extended delivery of up to four weeks.
   
In its letter, the FDA said it needs more information to better understand the risk and underlying cause of excessive sedation events that have been observed in about 1% of patients in clinical trials.  
   
“We are disappointed by the FDA’s decision and we are committed to ongoing discussions to better understand the agency’s perspective regarding this recent case of excessive sedation and to define the path forward and the associated timeline,” said Dr. Jennifer Stotka, vice president of U.S. regulatory affairs, Eli Lilly and Co. “Given the chronic and severe nature of schizophrenia, persistent challenges with adherence, and the limited number of approved depot formulations, we continue to believe that, if approved, Zyprexa LAI would provide a valuable treatment option for patients suffering from schizophrenia.”
   
Regulatory reviews of Zyprexa LAI applications are ongoing in the EU and other countries including Canada and Australia.