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FDA批准美国WorldMeds的B型肉毒杆菌MYOBLOC注射治疗慢性流涎

2019-08-27 不详 MedSci原创

WorldMeds宣布美国食品和药物管理局(FDA)批准其MYOBLOC(rimabotulinumtoxinB)注射剂的补充生物制剂许可申请(sBLA)用于治疗成人慢性流涎。

WorldMeds宣布美国食品和药物管理局(FDA)批准其MYOBLOC(rimabotulinumtoxinB)注射剂的补充生物制剂许可申请(sBLA)用于治疗成人慢性流涎。

流涎或流口水被定义为唾液从口腔中溢出过量。流涎是许多神经障碍的常见症状,例如帕金森病(PD)、肌萎缩侧索硬化症(ALS)、脑瘫、中风和其他病症,影响多达75%的PD患者,被认为是该疾病最令人烦恼的非运动症状之一。

MYOBLOC是第一种也是唯一一种经批准的B型肉毒杆菌毒素,可在1周内通过一次治疗显着减少流涎症状,并持续长达3个月。sBLA批准得到多项临床试验的支持,包括MYOBLOC的多中心、双盲、慰剂对照的疗效和安全性研究,并且与安慰剂相比具有统计学意义。本研究证明了MYOBLOC在随后的给药期内的安全性和有效性超过1年。在所有慢性流涎研究中报告的最常见的不良反应是口干,龋齿和吞咽困难。

MYOBLOC于2000年首次获得FDA批准用于治疗颈部肌张力障碍的成人。

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    2020-01-20 bugit
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    2019-08-29 徐岩

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