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Incannex Completes Positive Pre-IND Meeting with US FDA on IHL-216A for Treatment of Concussion and Traumatic Brain Injury
MELBOURNE, Australia, Oct. 11, 2022 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL) (‘Incannex’ or the ‘Company’), a clinical-stage
About this update from Incannex Healthcare Inc.
[{"type":"text","content":"MELBOURNE, Australia, Oct. 11, 2022 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL) (‘Incannex’ or the ‘Company’), a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, is pleased to announce that it has completed a constructive pre-Investigational New Drug Application (‘pre-IND’) meeting with the U.S. Food and Drug Administration (‘FDA’) for its proprietary drug product IHL-216A for treatment of traumatic brain injury and concussion (‘TBI’). IHL-216A is Incannex’s proprietary combination of cannabidiol (‘CBD’) and isoflurane (‘ISO’) that is being developed for treatment of TBI. Incannex submitted a pre-IND meeting package to the FDA in August 2022. The meeting package included a description of the unique formulation developed by Incannex, an overview of the proposed clinical development plan and specific questions Incannex submitted on the regulatory requirements for opening an Investigational New Drug application (‘IND’). Opening an IND is required to conduct trials in the United States and ensures that trials are designed to meet the data requirements necessary for FDA marketing approval. In written correspondence, FDA provided valuable, multidisciplinary feedback on the proposed clinical development of IHL-216A and acknowledged that treatment of TBI is a significant unmet medical need that requires innovative treatment solutions. The FDA also confirmed that the FDA505(b)2 application was the appropriate regulatory pathway for IHL-216A, whereby some of the information required for marketing approval may derive from studies already completed on the drug components of IHL-216A and in the public domain. FDA provided critical guidance on the data requirements for opening an IND for IHL-216A, particularly related to the intricacies of developing an inhaled drug product and conducting clinical trials that involve an anaesthetic. Incannex is drafting a follow-up request for additional information on the FDA’s recommendations and will provide an update to ASX and Nasdaq investor platforms when it has been received. Chief Scientific Officer of Incannex, Dr. Mark Bleackley, said: “Feedback from the FDA in the pre-IND meeting indicated that the agency is highly interested in the development of IHL-216A ...