CDMO awarded $850,000 contract for development of Acute Cannabinoid Overdose treatment

A contract development and manufacturing organisation (CDMO) has been awarded a contract worth $850,000 by the US National Center for Advancing Translational Sciences (NCATS), to develop a new injectable formulation of drinabant, a selective, high affinity cannabinoid receptor (CB-1) antagonist.

Drinabant is being developed by Opiant Pharmaceuticals, Inc. to treat individuals who have ingested large quantities of tetrahydrocannabinol (THC) – the principal active constituent of cannabis – or synthetic cannabinoids and are diagnosed with Acute Cannabinoid Overdose (ACO). There are currently no US Food and Drug Administration approved treatments for ACO.

Severe symptoms of ACO can include panic, anxiety, feelings of paranoia, agitation, visual and auditory hallucinations and nausea, which may take several hours or days to fully resolve.

The overall goal of the project is for the CDMO, IRISYS LLC, to develop a formulation of drinabant for parenteral administration that can reverse the symptoms of ACO rapidly and effectively. According to IRISYS, this is particularly important as young children are especially vulnerable to ACO as a result of mistakenly consuming THC containing edibles, such as brownies, cookies and candies with large quantities of THC.

Opiant originally identified this potential new use for drinabant, the NCATS Therapeutic Development Branch (TDB) then collaborated with them to optimise the drinabant drug product formulation and conduct toxicology/safety evaluation studies. IRISYS was then chosen, via a competitive bidding process, to develop a formulation for parenteral administration and manufacture it for use in Investigational New Drug (IND)-enabling studies and a Phase I clinical trial. IRISYS will also perform stability studies for three years.

“The need to quickly and effectively reverse ACO symptoms, including in vulnerable populations like children, is a strong motivating factor pushing us at IRISYS every day to put in the effort needed to ensure that this drug is ready for clinical trials as soon as possible,” stated Dr Robert Giannini, IRISYS president and Chief Scientific/Technical Officer.

This project has been funded in whole or in part with Federal funds from NCATS, under Contract Number HHSN271201700020I.