BDH PHARMA LLC — Department of Health and Human Services SBIR Phase I: NIDA

Description

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.Project Narrative The US is in the midst of an epidemic of opioid abuse and overdose and prescription opioids have become the “gateway drug” to opioid use disorder, heroin and illicit fentanyl use, and overdose. The development of novel therapeutics and biomedical strategies to prevent new cases of opioid misuse and addiction and to treat those with opioid use disorder are critical to address the current epidemic of opioid addiction and overdose. To achieve this goal, we propose studies that will advance the development of a cannabinoid-opioid combination analgesic that displays opioid sparing and synergistic analgesic effects resulting in lower risk of abuse, addiction, and overdose.