SAN DIEGO, Jan. 11, 2021 /PRNewswire/ -- 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.
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SOURCE IRISYS, LLC