SLOUGH, England, and RICHMOND, Va. — Indivior PLC is today providing an update following Aelis Farma’s announcement of the results from its clinical Phase 2B trial with AEF0117, evaluating the efficacy and safety in treatment-seeking participants with moderate to severe Cannabis Use Disorder (CUD). The purpose of this trial was twofold: (1) to show that AEF0117 (0.1, 0.3, 1 mg once a day for 12 weeks) lowers cannabis use and (2) to determine the endpoints and optimal dosage of AEF0117 for use in future studies. In this phase 2B study, patients were treatment-seeking participants, 84% of whom had severe CUD.
The results of the study demonstrated that the primary endpoint, the proportion of participants who reduced their cannabis use to ≤1 day per week, as well as secondary endpoints measuring the proportion of participants reaching either complete abstinence or who used ≤2 day per week, were not met. Although these results are disappointing, they indicate that significant work remains to be done to understand subpopulations of patients with CUD, specifically those with severe CUD.
This clinical Phase 2B study is part of the strategic collaboration between Aelis Farma and Indivior, which includes an exclusive option for Indivior to license the global rights to AEF0117. Given the lack of separation from placebo on primary and secondary endpoints and before seeing further additional favorable clinical data, Indivior does not currently expect to exercise its option.
About Indivior
Indivior is a global pharmaceutical company working to help change patients’ lives by developing medicines to treat substance use disorders (SUD), overdose and serious mental illnesses. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. Indivior is dedicated to transforming SUD from a global human crisis to a recognized and treated chronic disease.
Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of SUD. Headquartered in the United States in Richmond, VA, Indivior employs over 1,000 individuals globally and its portfolio of products is available in over 30 countries worldwide.
