FDA批准Amitiza治疗阿片类药物所致便秘

圣路易斯(MD Consult)——2013年4月23日，Sucampo公司宣布，美国食品药品管理局(FDA)已批准Amitiza(鲁比前列酮)用于治疗成人慢性非癌性疼痛患者因使用阿片类药物引起的便秘(OIC)。这是Amitiza的第三个适应证。该产品的另外两个核准适应证为治疗成人慢性特发性便秘和女性成人肠易激综合征伴便秘。

Amitiza是小肠表皮细胞中ClC-2氯离子通道的一种特异性活化剂。该产品可绕过阿片类药物的抗分泌作用。

对于该适应证的核准是基于多项为期12周的对因非癌性疼痛长期使用阿片类药物(包括吗啡、羟考酮和芬太尼)患者的3期对照研究和一项长期开放标记安全性研究的结果。两项3期研究达到总体疗效终点，另一项未达到总体疗效终点。

在OIC患者使用Amitiza(24 μg每日2次与安慰剂相比)的临床试验中，最常见的不良反应为恶心(11% vs. 5%)和腹泻(8% vs. 2%)。

对于有提示机械性胃肠梗阻症状的患者，在开始Amitiza治疗之前应进行全面评估，以排除此类梗阻。接受Amitiza治疗的患者可能在首次用药后1小时内发生呼吸困难，这种症状一般会在3小时内缓解，但重复用药时有可能再度发生。

尚不明确正在使用二苯基庚烷阿片类药物(如美沙酮)的患者采用Amitiza治疗OIC的有效性。

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ST LOUIS (MD Consult) - On April 23, 2013, Sucampo announced that the US Food and Drug Administration (FDA) has approved Amitiza (lubiprostone) for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain. This is the third approved indication for Amitiza. The product is also approved for the treatment of chronic idiopathic constipation in adults and irritable bowel syndrome with constipation in adult women.

Amitiza is a specific activator of ClC-2 chloride channels in the intestinal epithelium. The product bypasses the antisecretory action of opiates.

This approval was granted on the basis of results from phase 3, well-controlled studies of 12 weeks' duration in patients taking opioids (among them morphine, oxycodone, and fentanyl) chronically for non-cancer pain, as well as a long-term, open-label safety study, which provides additional support for use in this population. Two of the phase 3 studies met their overall efficacy end point, whereas a third phase 3 study did not.

In clinical trials of Amitiza (24 μg twice daily vs placebo) in patients with OIC, the most common adverse reactions were nausea (11% vs 5%) and diarrhea (8% vs 2%).

Patients with symptoms suggestive of mechanical gastrointestinal obstruction should be thoroughly evaluated to confirm the absence of such an obstruction before initiating treatment with Amitiza. Patients receiving Amitiza may experience dyspnea within an hour of the first dose. This symptom generally resolves within 3 hours, but may recur with repeat dosing.

The effectiveness of Amitiza in the treatment of OIC in patients taking diphenylheptane opioids (eg, methadone) has not been established.