ST LOUIS (MD Consult - On January 7, 2011, the US Food and Drug Administration (FDA) announced the approval of Abstral(fentanyl) transmucosal tablets to manage breakthrough pain in adults with cancer. Fentanyl immediate-release transmucosal medications are administered on the soft surfaces of the mouth, throat, or nasal passages.
Abstral is indicated for the management of breakthrough pain in patients who already receive opioid pain medication around the clock and who need and are able to safely use high doses of an additional opioid medication. Only health care professionals skilled in the use of Schedule II opioids to treat pain should prescribe this drug product.
Abstral is available only through the FDA's Risk Evaluation and Mitigation Strategy program, which is intended to minimize the risk of misuse, abuse, addiction, and overdose. Under this program, pharmacies, distributors, and health care professionals who prescribe to outpatients are required to enroll in the program to prescribe, dispense, and distribute this product.
The safety of Abstral was evaluated in 311 opioid-tolerant patients with cancer who were experiencing breakthrough pain. Two hundred seventy of these patients were treated in multiple-dose studies. The duration of therapy for patients in multiple-dose studies ranged from 1 to 405 days, with an average duration of 131 days and with 44 patients treated for at least 12 months.
Common adverse reactions associated with Abstral use include nausea, constipation, drowsiness, and headache. Serious adverse events, including deaths, have been reported in patients who received other immediate-release transmucosal fentanyl products. These deaths occurred as a result of improper patient selection and/or improper dosing, according to the FDA.
Abstral is formulated in 100-, 200-, 300-, 400-, 600-, and 800-μg strengths, and is expected to be available in the US market in early 2011.
圣路易斯(MD Consult)——2011年1月7日，美国食品药品管理局(FDA)宣布，Abstral(芬太尼)透黏膜片剂已获准用于控制成人癌症患者的突发性疼痛。芬太尼速释透黏膜片剂的用药部位包括口腔、咽喉部或鼻腔的软组织表面。
Abstral适用于已接受全天阿片类镇痛药治疗的患者，以及有必要并能够安全使用大剂量额外阿片类药物的患者，以控制其突发性疼痛。只有能熟练使用Ⅱ类阿片类镇痛药的医护专业人员才有该药品的处方权。
Abstral仅在实施FDA的风险评估与减缓策略(REMS)计划后方可使用，该计划旨在将误用、滥用、成瘾和过量的风险降到最低。REMS计划要求药店、分销商以及为门诊患者开具处方的医护专业人员在该计划的框架下开具本产品的处方以及进行配发和分销。
Abstral的安全性在311例对阿片类药物耐药且正经受突发性疼痛的癌症患者中得到评估。其中270例患者参与了多剂量治疗研究，其疗程介于1~405天，平均疗程为131天，有44例患者接受了至少12个月的治疗。
与使用Abstral有关的常见不良反应包括恶心、便秘、嗜睡和头痛。在接受其他芬太尼速释透黏膜制剂治疗的患者中已有死亡等严重不良事件的报告。据FDA称，发生这些死亡事件的原因是患者选择不当和(或)用药剂量不当。
Abstral的规格包括100 μg、200 μg、300 μg、400 μg、600 μg和800μg，预计将于2011年年初在美国上市。
