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LTR製藥公司稱,其治療勃起功能障礙的候選藥物二期臨床試驗中期數據顯示,藥物達到峰值濃度所需時間短,股價應聲上漲28%。

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-- LTR Pharma(ASX:LTP)週五在澳洲證券交易所提交的文件顯示,其用於治療勃起功能障礙的鼻噴劑SPONTAN的二期中期藥物動力學和安全性數據顯示,該藥物達峰時間短,且安全性良好。 該研究描述了美國食品藥物管理局(FDA)要求的關鍵藥物動力學參數,包括快速吸收、重複給藥行為以及在成人和老年人群中的一致性。根據文件,這些數據支持其計劃的FDA 505(b)(2)監管途徑,但需完成最終統計分析。 SPONTAN(5毫克)的中位達峰時間為10分鐘,而20毫克伐地那非口服藥錠的中位達峰時間為60分鐘。 SPONTAN的達峰時間範圍為10至15分鐘, 而口服片劑的達峰時間範圍為30至180分鐘。 65歲以上受試者的藥物動力學特徵與成人組相似,資料集未觀察到明顯差異。連續五天鼻內給藥SPONTAN未導致藥物蓄積。 根據提交的文件,未觀察到嚴重或重度治療期間出現的不良事件。 該公司股價在上週五的交易中上漲了28%。

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