Incannex granted Fast Track designation for IHL-42X in OSA

Incannex (IXHL) Healthcare announces that the U.S. Food and Drug Administration has granted Fast Track designation for IHL-42X, the Company’s oral fixed-dose combination product candidate for the treatment of obstructive sleep apnea. The Fast Track designation was supported by promising safety, efficacy, and pharmacokinetic results from the three clinical trials completed to date within the IHL-42X development program. These include the Company’s successful Phase 2 “RePOSA” study demonstrating statistically significant reductions in Apnea-Hypopnea Index, with individual reductions of up to 83%, outstanding patient-reported outcomes, and an excellent safety profile.