FDA Experts Weigh In On Incannex's CannQuit-O With Feedback On CBD As Treatment For Opioid Use Disorder
FDA Experts Weigh In On Incannex's CannQuit-O With Feedback On CBD As Treatment For Opioid Use Disorder
Incannex Healthcare Inc. (NASDAQ:IXHL), a cannabinoid and psychedelic medicine biotechnology company, announced the successful completion of a pre-investigational new drug meeting with the U.S. Food and Drug Administration (FDA) regarding the development of CannQuit-O for the treatment of opioid use disorder (OUD).
大麻素和迷幻醫學生物技術公司Incannex Healthcare Inc.（納斯達克股票代碼：IXHL）宣佈，成功完成了與美國食品藥品監督管理局（FDA）關於開發用於治療阿片類藥物使用障礙（OUD）的Cannquit-O的研究前新藥會議。
A number of FDA representatives shared insights on the CannQuit-O development program during the pre-IND teleconference in addition to providing recommendations on the proposed clinical development strategy.
除了就擬議的臨床開發戰略提供建議外，許多FDA代表在IND之前的電話會議上分享了對Cannquit-O開發計劃的見解。
CannQuit-O combines CBD and an off-patent prescription opioid antagonist, and/or partial agonist-antagonist within the formulation. It's a chewable tablet with unique characteristics provided by a novel combination of registered/FDA-approved polymers allowing for rapid and sustained release of its active ingredients.
Cannquit-O在配方中結合了CBD和非專利處方阿片類藥物拮抗劑和/或部分激動劑拮抗劑。它是一種具有獨特特性的咀嚼片，由註冊/美國食品藥品管理局批准的聚合物的新型組合而成，可快速持續釋放其活性成分。
The Melbourne, Australia-based company has engaged multinational contract development and manufacturing organization Eurofins Scientific ERFSF to manufacture Incannex's two distinct medicated chewable products designed to treat opioid addiction and nicotine disorders in 2022.
這家總部位於澳大利亞墨爾本的公司已聘請跨國合同開發和製造組織Eurofins Scientific ERFSF來生產Incannex的兩種不同的藥用咀嚼產品，旨在在2022年治療阿片類藥物成癮和尼古丁失調。
On Monday, Incannex officials said discussion with the FDA provided it with clarity on the data required to open an IND with the FDA for this product while providing valuable guidance for successful clinical development in the OUD indication.
週一，Incannex官員表示，與美國食品藥品管理局的討論使其明確了向美國食品藥品管理局開啓該產品臨床試驗所需的數據，同時爲OUD適應症的成功臨床開發提供了寶貴的指導。
"Developing new therapies, such as CannQuit-O, is critical for helping control the disease and improve quality of life for those who are suffering from the disease and those around them," said Incannex chief scientific officer Dr Mark Bleackley. "Feedback from the FDA on the proposed development strategy for CannQuit-O will be taken on board so that the outcomes of research activities meet agency expectations and ensure that the appropriate steps are being taken towards drug registration."
Incannex首席科學官馬克·布萊克利博士說：“開發諸如Cannquit-O之類的新療法對於幫助控制疾病和改善患有該疾病的人及其周圍人的生活質量至關重要。”“將採納美國食品藥品管理局對Cannquit-O擬議開發戰略的反饋，以使研究活動的結果符合機構的預期，並確保爲藥物註冊採取適當的措施。”
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IXHL Price Action
IXHL 價格走勢
Incannex Healthcare's shares traded 9.09% higher at $2.52 per share at the time of writing on Tuesday.
在週二撰寫本文時，Incannex Healthcare的股價上漲9.09％，至每股2.52美元。
譯文內容由第三人軟體翻譯。