Lilly Research Laboratories副總裁John Hayes醫師在新聞稿中表示，美國有越來越多的精神科醫師體認到，藥物順從性不佳是精神分裂症病患照護的一大障礙，長效型療法將有助於這些病患維持穩定的治療處方。Zyprexa Relprevv提供新的機轉，幫助適用的病患充分獲得olanzapine的特有療效。
December 15, 2009 — The US Food and Drug Administration (FDA) has approved olanzapine extended-release intramuscular injection (Zyprexa Relprevv, Eli Lilly Company) for the treatment of schizophrenia in adults.
The product, which provides therapeutic levels of olanzapine for 2 to 4 weeks, is intended to promote medication adherence and thereby break the "revolving door" cycle often associated with schizophrenic relapse.
"There is a growing recognition among psychiatrists in the United States that non-adherence to medication is an even greater barrier to care for patients with schizophrenia than was previously understood, and that long-acting treatments can play a beneficial role in helping patients maintain a stable treatment regimen," said John Hayes, MD, vice president of Lilly Research Laboratories, in a company news release. "Zyprexa Relprevv provides a new mechanism for helping appropriate patients benefit from the well-characterized efficacy of olanzapine."
Approval of the long-lasting formulation was based on data from clinical trials of 2054 patients, showing that its use effectively controlled schizophrenic symptoms such as hallucinations, delusions, apathy, and social withdrawal for up to 4 weeks.
The formulation's safety profile was similar to that of oral olanzapine, with the exception of injection-related events that included postinjection delirium/sedation syndrome. This syndrome was reported in less than 0.1% of injections and about 2% of patients, most frequently occurring within the first 3 hours of drug administration and resolving within 72 hours.
Because of these and other potential risks, a risk evaluation and mitigation strategy has been developed to restrict distribution of extended-release olanzapine to medical professionals or patients enrolled in the program.
Olanzapine extended-release intramuscular injection, marketed as Zypadhera, previously was approved for use in the European Union.
