FDA拒绝批准甲基纳曲酮新的适应症
8月2日消息--环球医学据悉,美国食品和药物管理局(FDA)拒绝批准甲基纳曲酮溴化物(Relistor,Salix制药公司和Progenics制药)用于治疗成人慢性非癌性疼痛患者的阿片类药物引起的便秘(OIC)。
FDA于上周五发出了关于补充新适应症申请的完整的答复信,表示需要更多的数据来支持拟议的新适应症。
目前,在美国,甲基纳曲酮溴化物用于治疗正在接受姑息治疗的晚期疾病患者的阿片类药物引起的便秘,但通便疗法的应答一直不够充分。
2008年,甲基纳曲酮溴化物被批准在美国上市,目前已在58个国家批准使用。
根据制造商的书面声明,该公司打算申请一个关于胃肠科和先天性缺陷产品的最终审查会议,以更好地了解这个完整的答复信中的内容。
尚未评估过去4个月使用本药物的安全性。最常见的不良反应是腹痛、胀气、恶心、头晕、腹泻和多汗。罕见报道胃肠穿孔病例。(环球医学)
原文
FDA Declines New Indication for Methylnaltrexone
July 31, 2012 — The US Food and Drug Administration (FDA) has declined approval of methylnaltrexone bromide (Relistor, Salix Pharmaceuticals, Ltd, and Progenics Pharmaceuticals) for treatment of opioid-induced constipation (OIC) in adult patients with chronic, noncancer pain.
The FDA issued a complete response letter on Friday of last week regarding a supplemental new drug application for this indication, stating that more data are needed to support the proposed new indication.
Currently, methylnaltrexone bromide in the United States is indicated for the treatment of opioid-induced constipation in patients with advanced illness who are receiving palliative care, but only when response to laxative therapy has not been sufficient.
The agent was approved in the United States in 2008 and is currently approved for use in 58 countries.
According to the manufacturers' written release, the companies intend to request an End-of-Review meeting with the Division of Gastroenterology and Inborn Errors Products to gain a better understanding of the contents of the complete response letter.
The safety of this agent has not been evaluated past 4 months of use. The most common adverse reactions are abdominal pain, flatulence, nausea, dizziness, diarrhea, and hyperhidrosis. Rare cases of gastrointestinal perforation have been reported.
原文链接:http://www.medscape.com/viewarticle/768404
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