-- LTR Pharma(ASX:LTP)周五在澳大利亚证券交易所提交的文件显示,其用于治疗勃起功能障碍的鼻喷剂SPONTAN的二期中期药代动力学和安全性数据显示,该药物达峰时间短,且安全性良好。 该研究描述了美国食品药品监督管理局(FDA)要求的关键药代动力学参数,包括快速吸收、重复给药行为以及在成人和老年人群中的一致性。根据文件,这些数据支持其计划的FDA 505(b)(2)监管途径,但需完成最终统计分析。 SPONTAN(5毫克)的中位达峰时间为10分钟,而20毫克伐地那非口服片剂的中位达峰时间为60分钟。SPONTAN的达峰时间范围为10至15分钟, 而口服片剂的达峰时间范围为30至180分钟。 65岁以上受试者的药代动力学特征与成人组相似,数据集未观察到明显差异。连续五天鼻内给药SPONTAN未导致药物蓄积。 根据提交的文件,未观察到严重或重度治疗期间出现的不良事件。 该公司股价在上周五的交易中上涨了28%。
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