Indivior Licenses Medication for Cannabis Use Disorder and Cannabis-Induced Psychosis
Once targeted for deceptive marketing related to an opioid addiction remedy, a company is now aiming for a different kind of substance abuse disorder. Indivior PLC is collaborating with France-based Aelis Farma on the development of a treatment for cannabis use disorder and cannabis-induced psychosis.
Indivior, which has offices in London and Richmond, Virginia, will pay Aelis Farma an upfront payment of $30 million for exclusive global rights to AEF0117, which recently completed Phase IIa studies. Aelis will conduct a planned Phase IIb study, and following that successful completion of that study, Indivior will pay Aelis an added $100 million before taking over Phase III development. Aelis will be eligible for additional milestone payments and potential royalties based upon future sales.
The license agreement also includes exclusive global rights on a patent covering AEF0117 and related compounds and methods of using patents for treating cannabis-related disorders, including CUD and CIP.
AEF0117 is Aelis' first-in-class synthetic Signaling Specific inhibitor engineered to inhibit the cannabinoid type 1 receptor. In the Phase IIa studies, AEF0117 showed positive efficacy signals in subjects with cannabis use disorder.
Mark Crossley, chief executive officer of Indivior, said the company’s focus is to address unmet needs for people struggling with substance use disorders. He noted that increasing the use of cannabis in the United States, particularly as more and more states and municipalities legalize its use, is elevating the risk of addiction.
It’s estimated that more than 48 million people in the United States used marijuana in 2019. Of those, about 4.8 million had a cannabis use disorder during that same period.
“Cannabis is the most commonly used substance of abuse in the U.S. after alcohol and tobacco. However, we have no FDA-approved medications for cannabis-related disorders, which are complex and concerning. AEF0117 is the most advanced new chemical entity under investigation in the clinic and potentially represents a unique opportunity to address a growing unmet public health need,” Crossley said in a statement.
In addition to use in the U.S., the United Nations estimates that 192 million people across the globe use cannabis, making it one of the most widely used drugs in the world. According to Indivior, a recent global burden of disease study estimated that 22.1 million people met the diagnostic criteria for cannabis use disorder, 289.7 cases per 100,000 people.
AEF0117 will complement other addiction-related medications within Indivior’s pipeline, including Subuxone, which is used to treat patients addicted to heroin and other opioids, Sublocade for opioid use disorder, and Nalscue, a nasal spray for opioid overdose.