Incannex Healthcare Inc. has been granted Fast Track designation by the FDA for IHL-42X, an oral fixed-dose combination product candidate for treating obstructive sleep apnea (OSA).
The Fast Track designation was supported by positive safety, efficacy, and pharmacokinetic results from three completed clinical trials within the IHL-42X development program.
This designation will allow Incannex to have more frequent interactions with the FDA, potentially access Accelerated Approval and Priority Review, and benefit from a streamlined regulatory pathway.
Fast Track Designation
FDA granted Fast Track designation to IHL-42X, recognizing its potential to address the unmet medical need in treating OSA patients.
Clinical Trial Results
Successful Phase 2 study showed significant reductions in Apnea-Hypopnea Index (AHI) of up to 83%, positive patient-reported outcomes, and excellent safety profile.
Future Development Steps
Incannex expects detailed feedback from the FDA on Phase 2 data, guiding the path towards late-stage development of IHL-42X.
- The Fast Track designation signifies a major regulatory milestone for Incannex, validating the strength of their data package and the potential of IHL-42X in transforming the treatment landscape for OSA.
- This designation will streamline the regulatory pathway, enabling Incannex to accelerate the development process and potentially bring the innovative therapy to patients sooner.
With the Fast Track designation from the FDA, Incannex is poised to advance the development of IHL-42X for obstructive sleep apnea, providing hope for patients in need of new treatment options.