IRISYS, LLC, a San Diego-based provider of contract pharmaceutical product development and manufacturing services, today announced that it was awarded a contract valued at $850,000 by the National Center for Advancing Translational Sciences (NCATS), one of 27 institutes of the NIH, to develop a new injectable formulation of drinabant, a selective, high affinity cannabinoid receptor (CB-1) antagonist. Opiant Pharmaceuticals, Inc. (“Opiant”), an NCATS collaborator, licensed drinabant from Sanofi and is developing it with the goal to treat individuals who have ingested large quantities of THC (the principal active constituent of cannabis) or synthetic cannabinoids, and are diagnosed with Acute Cannabinoid Overdose (ACO). This condition currently does not have any approved FDA treatment.
ACO can have severe symptoms, including panic, anxiety, feelings of paranoia, agitation, visual and auditory hallucinations, and nausea. ACO symptoms can take several hours or days to resolve fully. The project’s overall goal is to develop drinabant for parenteral administration to reverse the symptoms of ACO rapidly and effectively. It is important to keep in mind that THC containing “edibles” are usually in the form of brownies, cookies and candies that contain large quantities of THC. Young children are especially vulnerable because edibles are easily mistaken for treats.
Opiant identified this potential new use for drinabant, which led to the collaboration with the NCATS Therapeutic Development Branch (TDB) to optimize the drinabant drug product formulation and conduct toxicology/safety evaluation (IND-enabling) studies.
Through the collaboration process, Opiant needed a high-quality CDMO to support their project. The NIH selected IRISYS, via a competitive bidding process, to develop a formulation and manufacture batches of this drinabant formulation for parenteral administration in IND-enabling studies and a Phase 1 clinical trial, and to 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 Robert Giannini, Ph.D., IRISYS president and CSO/CTO.
This project has been funded in whole or in part with Federal funds from the National Center for Advancing Translational Sciences, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN271201700020I.