Aquestive Therapeutics Receives U.S. FDA Orphan Drug Exclusivity For Libervant Buccal Film In Pediatric Patients With Seizure Clusters Ages 2-5
Aquestive Therapeutics Receives U.S. FDA Orphan Drug Exclusivity For Libervant Buccal Film In Pediatric Patients With Seizure Clusters Ages 2-5
Aquestive Therapeutics, Inc. (NASDAQ:AQST) ("Aquestive" or the "Company"), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced the U.S. Food and Drug Administration (FDA) has granted seven years of orphan drug exclusivity (ODE) to Libervant (diazepam) Buccal Film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy between two to five years of age. On April 26, 2024, Libervant (diazepam) Buccal Film was approved for pediatric patients between two to five years of age. FDA granted ODE based on their assessment that Libervant's buccal route of administration provides a major contribution to patient care over the rectal route of administration by providing a significantly improved ease of use.
Aquestive Therapeutics, Inc. (納斯達克:AQST)（"Aquestive"或"公司"），是一家藥品公司，通過創新科學和輸送技術推進藥物，旨在爲患者的生活帶來重大改善。今天宣佈，美國食品和藥物管理局（FDA）已授予Libervant（地西泮）口腔薄膜七年的孤兒藥專屬性（ODE），用於急性治療癲癇患者在兩到五歲之間的間歇性、刻板性頻繁癲癇發作（即癲癇發作群、急性反覆癲癇發作），這些癲癇發作與患者的通常癲癇發作模式有所不同。2024年4月26日，Libervant（地西泮）口腔薄膜獲得了對兩到五歲之間兒童患者的批准。FDA根據其評估授予ODE，認爲Libervant的口腔給藥途徑對患者護理的重大貢獻超過了直腸給藥途徑，因爲它提供了顯著改善的使用便利性。
譯文內容由第三人軟體翻譯。
