The funds will be distributed over the course of 5 years to support preclinical through phase 2 studies.
The National Institute on Drug Abuse (NIDA) has awarded a grant of up to $16.6 million for the investigation of cebranopadol as a treatment for opioid use disorder (OUD).
NIDA—which is part of the National Institutes of Health (NIH)—will distribute the funds over the course of 5 years to Tris Pharma Inc, developer of cebranopadol, in support of its preclinical through phase 2 studies of the drug as a treatment for OUD. Preclinical studies will assess cebranopadol’s ability to deter self-administration of Schedule II opioids and its effects on respiratory function when co-administered with Schedule II opioids. Clinical studies will then assess cebranopadol’s addictive potential and explore the dosages that are needed to block withdrawal and subjective effects of dependence on opioids.1
Cebranopadol is an investigational, dual nociception/orphanin FQ peptide (NOP) receptor and an µ-opioid peptide (MOP) receptor agonist. It is the first and only full, dual NOP/MOP receptor agonist currently in clinical development. It received Fast Track Designation from the US Food & Drug Administration (FDA) for chronic low back pain in 2017.1
“Opioid overdose, misuse, and dependence have had a devastating impact on individuals, families, and communities, currently affecting an estimated 3 million Americans and accounting for $35 billion in US health care costs every year,” said Ketan Mehta, founder and chief executive officer at Tris Pharma, in a press release. “We are honored that NIDA has chosen to support the further development of cebranopadol as a potential new treatment to help address this complex, growing and costly global problem.”1
1. Tris Pharma awarded five-year grant of up to $16.6M from the NIH’s National Institute on Drug Abuse to advance cebranopadol for the treatment of opioid use disorder. BusinessWire. News release. August 28, 2023. Accessed August 30, 2023. https://www.businesswire.com/news/home/20230828282884/en/Tris-Pharma-Awarded-Five-Year-Grant-of-Up-to-16.6M-From-the-NIHs-National-Institute-on-Drug-Abuse-to-Advance-Cebranopadol-for-the-Treatment-of-Opioid-Use-Disorder