ST LOUIS (MD Consult) - On July 16, 2009, the US Food and Drug Administration (FDA) announced the approval of Onsolis, a formulation of fentanyl, indicated for the management of breakthrough pain in adults with cancer. Patients who are appropriate candidates for Onsolis therapy are those considered opioid-tolerant (ie, they are already receiving opioid medication around-the-clock).

Onsolis is formulated as a small dissolvable disc, and is applied to the inside of the cheek. The opiate within the disc is delivered intrabuccally.

Because fentanyl is subject to abuse and misuse, Onsolis was approved with a Risk Evaluation and Mitigation Strategy, or REMS, which is a required plan designed by the FDA for managing risks associated with a drug or biologic product. As part of the REMS, Onsolis will only be available through a restricted distribution program called the FOCUS program. Under this program, only those prescribers, patients, and pharmacies registered with the program will be able to prescribe, dispense, and receive Onsolis. The FOCUS program will provide training and educational materials to prescribers and pharmacy personnel, and a counseling call will be placed to patients before the drug is dispensed to ensure they have been adequately educated about the appropriate use of the drug. Prescription orders will be filled only by participating pharmacies that send the product directly to the patients' homes.

Onsolis was approved with a boxed warning, which states that the medication should not be used for the management of migraines, dental pain, postoperative pain, or by patients who take opioids intermittently or on an as-needed basis. The warning also states that the drug should be kept out of the reach of children and should not be substituted for other fentanyl products.

圣路易斯(MD Consult)——2009年7月16日，美国食品药品管理局(FDA)宣布，批准Onsolis(一种芬太尼制剂)用于治疗成人癌症患者突发性疼痛。Onsolis适用治疗者为那些被视为对阿片类药物耐受(即，已连续24h接受阿片类药物治疗)的患者。

Onsolis为一种可溶性小圆盘状膜片，贴敷于面颊内表面应用，而其中的阿片则向面颊内释放。

 

由于芬太尼易于造成滥用和误用，Onsolis获准时还有一项风险评估与降低策略(REMS)——由FDA设计的用于控制药品或生物制剂相关风险而必需提交的计划。作为REMS的组成部分，Onsolis仅可通过名为FOCUS系统的一个限制性销售系统购得。在该系统中，仅处方者、患者以及系统下注册的药房能开处方、销售以及获得Onsolis。FOCUS系统将为处方者和药房工作人员提供培训和教育资料，并且在药物发放前还将致电患者，以确保患者经教育充分掌握了正确的应用方法。处方单仅由注册过的药房填写，且由它们负责将药品直接发送至患者家中。

Onsolis的黑框警告声明，此药不可用于缓解偏头痛、牙痛和术后疼痛，间歇性应用阿片类药物或其应用剂量与需求量相当的患者亦不应服用此药。该警告还声明，此药应远离儿童接触范围存放，不可用于替代其他芬太尼药品。