Incannex Complete Successful Pre-IND Meeting with the FDA for CannQuit-O for treatment of opioid use disorder
Incannex Healthcare Inc. (IXHL)
Company Research
Source: GlobeNewswire
MELBOURNE, Australia and NEW YORK, May 07, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (Incannex or the Company), a leading cannabinoid and psychedelic medicine biotechnology company, is pleased to announce the successful completion of a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the development of CannQuit-O for treatment of Opioid Use Disorder (OUD). The pre-IND teleconference included representatives from various divisions of the FDA providing input on the CannQuit-O development program. The Agency had reviewed the CannQuit-O meeting package and provided recommendations on the proposed clinical development strategy, including patient populations, the selection and timing of efficacy endpoints and safety monitoring. These recommendations were discussed during the pre-IND teleconference where the company had the opportunity to seek further clarification on the agency’s initial response. The productiv
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IXHL
Sec Filings
- 9/10/24 - Form 8-K
- 9/10/24 - Form 8-K
- 9/10/24 - Form RW
- IXHL's page on the SEC website