# Development of cannabinoid-opioid combination with opioid sparing and synergistic analgesic effects to prevent opioid use disorder and overdose.

> **NIH NIH R43** · BDH PHARMA, LLC · 2020 · $55,000

## Abstract

Project Summary/Abstract
Approximately 2 million individuals in the US meet criteria for an opioid use disorder, with
millions more reporting use or misuse of opioid pain relievers in the past month. Along with an
increase in opioid use disorders, a rise in opioid-related overdose deaths has occurred in the
last decade reaching a public health crisis. Chronic pain and opioid abuse are more prevalent
than before constituting a public health crisis and exacting a heavy toll on patients, caregivers,
physicians and society. There is a current therapeutic challenge for managing opioid use
disorder, opioid withdrawal symptoms, chronic pain, and/or associated anxiety and depression.
A severe need remains for alternative and safe therapeutic regimens that properly treat these
conditions. We propose to develop a cannabinoid-opioid combination with opioid sparing and
synergistic analgesic effects to prevent opioid use disorder and overdose​, ​addressing the
current national opioid crisis. BDH Pharma, LLC recently completed a proof-of-concept
preclinical study of a cannabinoid-opioid combination that demonstrated opioid sparing and
synergistic analgesic effects, with the combination providing greater analgesia in a rodent model
of chronic pain than a standard dose of the opioid alone. These results suggest that a
fixed-dose combination (FDC) of the cannabinoid-opioid may have improved analgesia with
lower opioid doses and thereby lower the risk of dependence, withdrawal, diversion, abuse, and
overdose. This proposal will continue the development of the FDC by completing a preclinical
pharmacokinetic and ​in vivo ​safety study to determine if co-administration alters the
pharmacokinetics and/or respiratory depression related to either compound in rodents. Upon
completion of the proposed Phase 1 aims, we will submit a Phase 2 SBIR application to
complete any additional preclinical studies required by the FDA, to complete formulation
studies​, and to support the manufacturing under GMP conditions of the final clinical dosage
form that will be used in a subsequent phase 1 clinical trial of the FDC in humans.

## Key facts

- **NIH application ID:** 10118287
- **Project number:** 3R43DA050397-01S1
- **Recipient organization:** BDH PHARMA, LLC
- **Principal Investigator:** Marisa Briones
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $55,000
- **Award type:** 3
- **Project period:** 2019-09-30 → 2020-09-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10118287

## Citation

> US National Institutes of Health, RePORTER application 10118287, Development of cannabinoid-opioid combination with opioid sparing and synergistic analgesic effects to prevent opioid use disorder and overdose. (3R43DA050397-01S1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10118287. Licensed CC0.

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