$IXHL announce that it completed a highly construc
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Posted On: 05/26/2022 1:37:38 PM
$IXHL announce that it completed a highly constructive Pre-Investigational New Drug Application ('pre-IND') meeting with the U.S. Food and Drug Administration ('FDA') to discuss the development IHL-42X.
IHL-42X is a fixed dose combination of dronabinol and acetazolamide that is being developed as a treatment for obstructive sleep apnoea ('OSA') in adults. Incannex submitted a pre-IND meeting package and meeting request to the FDA in February 2022. The meeting package included an overview of the development program, and specific questions Incannex had on the regulatory requirements for opening an investigational new drug ('IND') application. Opening an IND is required to conduct clinical trials in the U.S and ensures that trials are designed so that they meet the data requirements necessary for FDA marketing approval.
The written responses, and the responses provided in a teleconference with FDA representatives, were constructive and supportive, with interest in the project underpinned by the significant cohort of people diagnosed with OSA and the absence of pharmacological treatment solutions.
FDA provided guidance on Incannex's proposed long-term development strategy, including specific parameters to demonstrate safety and efficacy in phase 2 and 3 pivotal studies. Guidance provided by the FDA to the Company will inform adjustments to the clinical trial protocols to ensure that they generate the data required for a 505(b)(2) new drug application (NDA).
In a decision that will save Incannex time and cost, FDA agreed that Incannex does not need to conduct studies in animals. In particular, the agency confirmed that animal toxicology and animal pharmacokinetic (PK) studies are not required for opening an IND for IHL-42X. Therefore, the next step for the development of IHL-42X will be the adjustment of clinical trial designs and arrangement of operational imperatives necessary to open an IND with FDA.
https://finance.yahoo.com/news/incannex-annou...00713.html
IHL-42X is a fixed dose combination of dronabinol and acetazolamide that is being developed as a treatment for obstructive sleep apnoea ('OSA') in adults. Incannex submitted a pre-IND meeting package and meeting request to the FDA in February 2022. The meeting package included an overview of the development program, and specific questions Incannex had on the regulatory requirements for opening an investigational new drug ('IND') application. Opening an IND is required to conduct clinical trials in the U.S and ensures that trials are designed so that they meet the data requirements necessary for FDA marketing approval.
The written responses, and the responses provided in a teleconference with FDA representatives, were constructive and supportive, with interest in the project underpinned by the significant cohort of people diagnosed with OSA and the absence of pharmacological treatment solutions.
FDA provided guidance on Incannex's proposed long-term development strategy, including specific parameters to demonstrate safety and efficacy in phase 2 and 3 pivotal studies. Guidance provided by the FDA to the Company will inform adjustments to the clinical trial protocols to ensure that they generate the data required for a 505(b)(2) new drug application (NDA).
In a decision that will save Incannex time and cost, FDA agreed that Incannex does not need to conduct studies in animals. In particular, the agency confirmed that animal toxicology and animal pharmacokinetic (PK) studies are not required for opening an IND for IHL-42X. Therefore, the next step for the development of IHL-42X will be the adjustment of clinical trial designs and arrangement of operational imperatives necessary to open an IND with FDA.
https://finance.yahoo.com/news/incannex-annou...00713.html
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