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康哲藥業(0867.HK)創新藥地西泮鼻噴霧劑中國註冊性橋接試驗達到預期目標
格隆匯 03-27 17:02

康哲藥業(0867.HK)宣佈完成重磅創新藥地西泮鼻噴霧劑的中國註冊性橋接試驗——比較PK研究。該研究結果顯示:單次鼻腔給藥地西泮鼻噴霧劑吸收迅速且完全,地西泮及其活性代謝產物去甲基地西泮的藥代動力學參數與美國相關研究結果類似,達到了預期目標。在健康的中國受試者中也顯示出良好的安全耐受性。

此項研究為單中心、隨機、開放、兩製劑、兩週期、雙交叉的比較藥代動力學研究(“比較PK研究”),根據中國NMPA簽發的臨牀試驗通知書要求,康哲藥業需開展此研究進行橋接以支持地西泮鼻噴霧劑上市。此次研究的臨牀數據,進一步確認了地西泮鼻噴霧劑具有良好的臨牀表現,為該產品在中國患者的臨牀使用提供了重要依據。康哲藥業將於近期提交地西泮鼻噴霧劑中國上市申請。

關於產品

地西泮鼻噴霧劑是地西泮的專有製劑,其配方結合了基於維生素E溶劑和Intravail®吸收增強劑的獨特組合,以期在鼻腔配方中獲得突出的吸收性、耐受性和可靠性;與靜脈注射地西泮相比,其絕對生物利用度較高,且變異性低。地西泮鼻噴霧劑已獲批以VALTOCO®商品名稱在美國上市,用於治療6歲及以上癲癇患者的間歇性、刻板性癲癇頻繁發作活動(即癲癇叢集性發作、急性反覆性癲癇發作)。

中國活動性癲癇患者約600萬,每年新發患者約40萬。得到正規治療的癲癇患者(約200萬)中,仍有20%-30%無法得到有效控制,癲癇反覆發作次數頻繁,平均每年近70次之多。地西泮鼻噴霧劑一旦在中國獲批,將成為急性反覆發作癲癇患者的長期必備、安全有效的藥物,市場前景可期。

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