NEW YORK -- December 14, 2009 -- The US Food and Drug Administration (FDA) has approved olanzapine (ZYPREXA RELPREVV) as an extended release injectable suspension form for the treatment of schizophrenia in adults.
The approval is based on data involving 2,054 patients, in which intramuscular olanzapine injection was found to be effective in controlling symptoms of schizophrenia, including hallucinations, delusions, apathy, and social withdrawal.
Efficacy was shown without the need for oral supplementation. Data showed that the olanzapine intramuscular injection at doses of 150, 210, 300, and 405 mg provides therapeutic exposure for 2 or 4 weeks depending on the dose.
The intramuscular injection was found to have a similar safety profile as oral olanzapine, with the exception of injection-related events, including post-injection delirium/sedation syndrome (PDSS). As of November 30, 2009, across all clinical trials, PDSS events have occurred in < 0.1% of injections and approximately 2% of patients.
The potential for onset of an event is greatest within the first hour after injection. The majority of cases have occurred within the first 3 hours after injection; however cases have occurred after 3 hours. All patients largely recovered within 72 hours and the majority of these patients have chosen to continue treatment.
Labeling for olanzapine intramuscular injection includes a requirement for the patient to be observed at a healthcare facility with ready access to emergency response services for at least 3 hours following each injection and to be accompanied to his or her destination upon leaving the facility.
The manufacturer, Eli Lilly, has worked with the FDA to develop a Risk Evaluation and Mitigation Strategy, which includes a communication plan, a patient medication guide, and a mandatory Patient Care Program, which restricts distribution of olanzapine intramuscular injection to prescribers, healthcare facilities, pharmacy service providers and patients enrolled in the program.
SOURCE: Eli Lilly and Company
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