The US Food and Drug Administration (FDA) has granted clearance to Incannex Healthcare’s investigational new drug (IND) application enabling the initiation of a Phase II/III study of IHL-42X for the treatment of obstructive sleep apnoea.

The FDA granted the approval after completing its review of the substantial application submitted to the authority on 20 July.

Incannex’s pivotal trial will evaluate the effect of IHL-42X in obstructive sleep apnoea patients who are intolerant, non-compliant, or naive to positive airway pressure treatment, administered via CPAP devices.

Patients will receive one dose of IHL-42X, dronabinol, acetazolamide or placebo.

They will complete daily surveys on their sleep quality and attend the clinic monthly for their sleep and cognitive function assessments and other safety and efficacy measures.

A polysomnography will also be conducted overnight in patients every three months to determine the effect of treatment on the Apnoea-Hypopnea Index (AHI) along with various other sleep parameters.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

IHL-42X is a combination of dronabinol, a synthetic form of tetrahydrocannabinol (THC), and acetazolamide, a carbonic anhydrase inhibitor.

In earlier Phase II proof of concept study, IHL-42X was found to reduce AHI by an average of 50.7% versus baseline assessments.

The concentrations of THC in blood were also observed to be below the limits for impaired driving the morning after nocturnal IHL-42X dose administration.

Furthermore, no serious treatment-emergent adverse events were reported during the study.