Source: DGNews  |  Posted 2 years ago

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