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).
大麻素和迷幻医学生物技术公司Incannex Healthcare Inc.（纳斯达克股票代码：IXHL）宣布，成功完成了与美国食品药品监督管理局（FDA）关于开发用于治疗阿片类药物使用障碍（OUD）的Cannquit-O的研究前新药会议。
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.
除了就拟议的临床开发战略提供建议外，许多FDA代表在IND之前的电话会议上分享了对Cannquit-O开发计划的见解。
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在配方中结合了CBD和非专利处方阿片类药物拮抗剂和/或部分激动剂拮抗剂。它是一种具有独特特性的咀嚼片，由注册/美国食品药品管理局批准的聚合物的新型组合而成，可快速持续释放其活性成分。
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.
这家总部位于澳大利亚墨尔本的公司已聘请跨国合同开发和制造组织Eurofins Scientific ERFSF来生产Incannex的两种不同的药用咀嚼产品，旨在在2022年治疗阿片类药物成瘾和尼古丁失调。
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.
周一，Incannex官员表示，与美国食品药品管理局的讨论使其明确了向美国食品药品管理局开启该产品临床试验所需的数据，同时为OUD适应症的成功临床开发提供了宝贵的指导。
"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首席科学官马克·布莱克利博士说：“开发诸如Cannquit-O之类的新疗法对于帮助控制疾病和改善患有该疾病的人及其周围人的生活质量至关重要。”“将采纳美国食品药品管理局对Cannquit-O拟议开发战略的反馈，以使研究活动的结果符合机构的预期，并确保为药物注册采取适当的措施。”
Innovation in cannabis will surely be one of hot topic at Benzinga's next cannabis event in Illinois. Want to understand what this means for the future of the industry? Hear directly for top executives, investors and policymakers at the 19th Benzinga Cannabis Capital Conference, coming to Chicago this Oct. 8-9. Get your tickets now before prices surge by following this link.
大麻创新肯定会成为Benzinga在伊利诺伊州举行的下一次大麻活动的热门话题之一。想了解这对该行业的未来意味着什么吗？在将于10月8日至9日在芝加哥举行的第19届Benzinga大麻资本会议上，直接听取高层管理人员、投资者和决策者的意见。点击此链接，立即在价格飙升之前获取门票。
IXHL Price Action
IXHL 价格走势
Incannex Healthcare's shares traded 9.09% higher at $2.52 per share at the time of writing on Tuesday.
在周二撰写本文时，Incannex Healthcare的股价上涨9.09％，至每股2.52美元。
译文内容由第三方软件翻译。