FDA批准氢可酮缓释胶囊

10月25日，美国食品药品管理局(FDA) 已批准酒石酸氢可酮缓释胶囊用于其他治疗方案不能充分控制且每天需要服药的重度疼痛患者的长期治疗。

该药物将以商品名Zohydro ER上市，是FDA批准的首个不含其它镇痛药物的氢可酮缓释制剂。按照《管制物质法案》，该药物属于Ⅱ类管制药物。

去年12月，FDA麻醉与镇痛药品专家委员会建议不予批准Zohydro，认为需要防治药物被破坏的处方设计和更为严格的风险减缓策略，以应对滥用和误用的高潜在风险。该委员会成员以11票反对、2票赞成和1票弃权的投票结果，反对批准该药物，尽管他们承认制造商符合所申请适应证获批的要求。然而，由于担心这种不含对乙酰氨基酚的氢可酮缓释制剂更易被滥用，特别是作为静脉药物滥用，加之没有采取防滥用设计，因此影响了专家投票结果。

在审批过程中，FDA注意到，该药物的新说明书符合FDA 9月份制定的新说明书要求，针对缓释制剂和长效阿片类镇痛剂的风险和安全性提出了更为强烈的警告，并按照新说明书要求制定了风险评估与减缓策略(REMS)。

FDA声明指出：“这些警告旨在通过鼓励更为合理的处方、患者监测和咨询实践，以提高所有这类药物的安全性。Zohydro ER是首个以这种方式制定说明书的阿片类药物。”

该批准令是基于纳入1,100余例慢性疼痛患者的安全性研究和纳入500余例慢性腰痛患者的有效性研究结果。有效性研究结果显示，与安慰剂相比，Zohydro ER可显著改善患者慢性疼痛。

FDA还要求生产商开展Zohydro ER上市后研究，以评估用药时间超过12周时潜在的滥用/过量使用和痛觉过敏风险。

Zohydro ER由位于圣迭戈的Zogenix公司生产。

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By: DENISE FULTON, Internal Medicine News Digital Network

Hydrocodone bitartrate extended-release capsules were approved by the Food and Drug Administration Oct. 25 for severe pain requiring daily long-term treatment and for which other treatment options are inadequate.

The drug, to be marketed as Zohydro ER, is the first FDA-approved extended-release formulation of hydrocodone that is not combined with another analgesic. It is classified as Schedule II under the Controlled Substances Act.

In December, an FDA advisory committee recommended against approval of Zohydro, citing the need for a tamper-proof formulation and a stronger risk mitigation strategy to address the high potential for abuse and misuse of the product.

Experts on the Anesthetic and Analgesic Drug Products Advisory Committee voted 11-2, with 1 abstention, against approval, although they agreed that the manufacturer met the standards for approval for the proposed indication.

However, concerns about the potential public health impact of the availability of an extended-release formulation of hydrocodone that does not contain acetaminophen – which would make it more attractive as a drug of abuse, particularly for intravenous drug abusers – or a tamper-resistant design, swayed their votes.

In approving the drug, the FDA noted that it carries new labeling and stronger warnings regarding the risks and safety of extended-release and long-acting opioid analgesics. The new labeling requirements were instituted by the agency in September. The drug also will be included in the Risk Evaluation and Mitigation Strategy (REMS) associated with the new labeling requirements.

"These warnings are expected to improve the safety of all such medicines by encouraging more appropriate prescribing, patient monitoring, and patient counseling practices," the FDA said in a statement. "Zohydro ER is the first opioid to be labeled in this manner."

Approval was based on safety studies of more than 1,100 chronic pain patients as well as efficacy studies of more than 500 chronic low-back-pain patients. Patients taking Zohydro ER in the efficacy study showed significant improvement in chronic pain, compared with those who took placebo.

FDA will require postmarketing studies of Zohydro ER to study potential abuse/overdose and hyperalgesia when used longer than 12 weeks.

Zohydro ER is manufactured by San Diego–based Zogenix.

Elizabeth Mechcatie contributed to this report.