Zubsolv获准用于治疗阿片类依赖患者

圣路易斯(MD Consult)——2013年7月4日，Orexo公司宣布，美国食品药品管理局(FDA)已批准Zubsolv(丁丙诺啡/纳洛酮)用于阿片类依赖患者的维持治疗。该药物将作为包括咨询和社会心理支持在内的完整治疗计划的一部分。

根据该产品标签，Zubsolv属于阿片受体部分激动剂，剂型为薄荷口味的舌下速溶片，每日用药1次。Orexo公司称，与其他丁丙诺啡/纳洛酮药物相比，Zubsolv生物利用度高、溶解迅速且片型较小。

临床试验和上市后应用情况显示，这种丁丙诺啡/纳洛酮舌下片的常见不良事件包括头痛、恶心、呕吐、多汗、便秘、戒断症状、失眠、疼痛及外周水肿。

根据该产品标签，丁丙诺啡可能被以类似其他阿片类药物的方式被滥用，有必要根据患者的稳定程度开展适当的临床监测。在治疗初期或缺乏合适随访的情况下，不应开具多次取药处方。

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ST LOUIS (MD Consult) - On July 4, 2013, Orexo announced that the US Food and Drug Administration (FDA) has approved Zubsolv (buprenorphine/naloxone) for use as maintenance treatment in persons with opioid dependence. The medication is intended to be used as part of a complete treatment plan that includes counseling and psychosocial support.

According to the product label, Zubsolv is a partial opioid agonist. It is formulated as a menthol-flavored, fast-dissolving sublingual tablet that is administered once daily. Orexo states that, compared with other buprenorphine/naloxone treatments, Zubsolv has higher bioavailability, faster dissolve time, and smaller tablet size.

Adverse events commonly observed with administration of buprenorphine/naloxone sublingual tablets during clinical trials and postmarketing experience are headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema.

According to the product label, buprenorphine can be abused in a similar manner to other opioids. Clinical monitoring appropriate to a patient's level of stability is essential. Multiple refills should not be prescribed early in treatment or without appropriate patient follow-up visits.