lavie 2009-12-29 12:47
FDA核准長效Olanzapine注射劑
作者：Yael Waknine
出處：WebMD醫學新聞
December 15, 2009 — 美國食品藥物管理局(FDA)核准olanzapine緩釋肌肉注射劑(商品名Zyprexa Relprevv，Eli Lilly Company藥廠)，用於治療成人精神分裂症。
該產品可提供olanzapine的治療濃度2-4週，目的在促進藥物順從性，因此避免與精神分裂症復發有關的「旋轉門」循環。
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。
這項長效配方的核准是根據2,054名病患的臨床試驗，使用它可以有效控制精神分裂症狀，如幻覺、妄想、冷漠以及社會隱蔽現象達4週之久。
該配方的安全性資料和口服olanzapine相似，除了注射相關反應，如注射後譫妄/鎮靜症候群，這些症候群發生率小於0.1%的注射件數以及約2%的病患，多數發生於給藥後的3小時內，且在72小時內可以緩解。
基於前述症候群與其他可能風險，需發展一套風險評估與緩解策略，以使緩釋型olanzapine僅限醫療專業人士與納入計畫的病患。
Olanzapine緩釋型肌肉注射劑由Zypadhera行銷，之前獲得歐盟核准使用。
FDA Approves Long-Acting Olanzapine Injection
By Yael Waknine
Medscape Medical News
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.