The US Food and Drug Administration's (FDA) Psychopharmacologic Drugs Advisory Committee voted that, with appropriate labelling around excessive sedation events, Eli Lilly's schizophrenia drug Zyprexa has been shown to be effective and acceptably safe for the treatment and maintenance treatment.
Zyprexa LAI is an investigational formulation that combines the atypical antipsychotic medication Zyprexa (olanzapine) with a pamoate salt, resulting in an extended delivery of up to four weeks.
"A primary barrier to the successful treatment of schizophrenia, a chronic and devastating illness, is that patients often relapse because they have trouble taking their medication on a regular basis," said Dr. John Kane, chairman, Department of Psychiatry, The Zucker Hillside Hospital, Glen Oaks, N.Y. "Long-acting injectable antipsychotics can help patients derive more consistent benefits from their medications."
The committee reviewed data from a comprehensive clinical program comprising eight studies. Results from the clinical trials showed greater symptom improvement in Zyprexa LAI-treated patients, compared with those on placebo. Due to the nature of the formulation of Zyprexa LAI, supplementation with oral antipsychotics was not needed to achieve or maintain effect in these studies.
John Hayes, M.D., vice president, Lilly Research Laboratories, said, "Due to the chronic and severe nature of the illness and the limited number of approved long-acting formulations, we believe that, if approved, Zyprexa LAI could be an important treatment option for this patient population, who struggle with taking their medication. We are pleased with the committee's recommendation and will continue to work with the FDA in its review of our application."
In clinical trials, Zyprexa LAI had a safety profile similar to oral olanzapine, with the exception of post- injection excessive sedation events, which also include dizziness, confusion and altered speech. These events were seen in 0.07 percent of injections and 1.2 per cent of patients, all of whom recovered fully.
To help minimize the risks associated with these excessive sedation events, Lilly included a proposed plan to manage those risks as part of its submission to the FDA. The committee also discussed the need for appropriate labelling to address the risks associated with excessive sedation events.
FDA reviewers will consider the panel's favourable recommendation in its review of the New Drug Application (NDA) that Lilly submitted for Zyprexa LAI. The FDA is not bound by its advisory committees' recommendations, but takes their advice into consideration when reviewing investigational drugs seeking approval.
Zyprexa is indicated in the United States for the short- and long-term treatment of schizophrenia, acute mixed and manic episodes of bipolar disorder, and maintenance treatment of bipolar disorder. Since Zyprexa was introduced in 1996, it has been prescribed to approximately 22 million people worldwide. Zyprexa is not approved for patients under 18 years of age.