无需吃药!FDA批准**精神分裂症皮肤给药疗法

2019-10-16 佚名 药明康德

今日,久光制药(Hisamitsu Pharmaceutical)旗下的Noven Pharmaceuticals公司宣布,美国FDA批准其透皮给药系统Secuado(asenapine)上市,用于治疗精神分裂症成人患者。Secuado是目前首款,也是唯一一款用于治疗精神分裂症患者的透皮贴剂(transdermal patch)疗法。

今日,久光制药(Hisamitsu Pharmaceutical)旗下的Noven Pharmaceuticals公司宣布,美国FDA批准其透皮给药系统Secuado(asenapine)上市,用于治疗精神分裂症成人患者。Secuado是目前首款,也是唯一一款用于治疗精神分裂症患者的透皮贴剂(transdermal patch)疗法。

精神分裂症是一种严重的慢性精神疾病,其症状分为三大类:阳性症状(幻觉,妄想,思维障碍和运动障碍),阴性症状(如缺乏动力和社交回避),以及认知症状(执行功能、注意力和工作记忆等方面出现问题)。精神分裂症的症状通常在16到30岁之间开始出现,极大的影响了患者的生活质量和社会行为。在全世界范围内,这种疾病影响人数超过2300万,对于公共卫生是一项重要的挑战。

Secuado是非典型抗精神病药物asenapine的透皮皮贴剂疗法。Noven公司开发的透皮给药系统(TDDS)可以在给药的24小时内维持血液中的药物浓度。与其它给药方式相比,这种透皮贴剂疗法可能更有助于精神分裂症患者的治疗。与口服或注射制剂相比,透皮贴剂疗法的侵入性相对较低,耐受性更好。其使用方式简单,由患者或护理人员便可轻松完成。这种方式还减少了给药频率,大幅度提高了患者的用药依从性。





透皮给药机理(图片来源:参考资料)

另外,透皮给药方式避免了口服药物的肝首过效应(hepatic-first pass,指的是经肠道给药的药物,在未进入血液循环之前先被肝脏代谢,导致进入体循环的药物水平下降),因此可能使用更低剂量就能达到同样疗效。此外,当不需要药物递送到体内时,只需要去除贴片,便可以停止药物传输,提高了患者用药时间的精确度。目前的研究显示,这种透皮给药技术适用于具有高脂溶性的低分子量药物,有望未来在一些医疗领域带来新的突破。





透皮给药与口服给药的血液药物浓度随时间变化过程(图片来源:参考资料)

Secuado的批准是基于一项双盲,含安慰剂对照组的3期临床研究。该试验在为期6周的治疗期内,对616名精神分裂症成人患者进行了有效性和安全性评估。试验结果显示,与安慰剂组相比,Secuado在第6周的阳性和阴性症状量表(PANSS)总分较基线时得到显着改善,达到了试验的主要终点。患者的疾病严重程度-临床总体印象量表(CGI-S)的评估也达到了统计学意义的改善,即该试验的关键性次要终点。此外,Secuado的安全性与asenapine舌下片剂的已知安全性一致。

“目前,精神分裂症的治疗方法仍存在高度尚未被满足的需求。Noven公司致力于为患有这种毁灭性疾病的患者及其家人提供新的治疗选择,帮助他们有效地治疗疾病,”Noven公司董事长兼首席执行官Naruhito Higo博士说:“很高兴美国FDA可以批准Secuado上市。我们希望可以尽快将其投放到美国市场,为精神分裂症患者提供一种asenapine的透皮给药疗法。”

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    2019-12-17 bugit
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