Funded Projects

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Project # Project Title Research Focus Area Research Program Administering IC Institution(s) Investigator(s) Location(s) Year Awarded
1UG3DA047700-01
Biased Mu-Opioid Receptor Analgesics to Prevent Overdose and Opioid Use Disorders Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA MEBIAS DISCOVERY, LLC KUO, LAWRENCE C Philadelphia, PA 2019
NOFO Title: Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)
NOFO Number: RFA-DA-19-002
Summary:

The adverse effects of morphine and other mu-opioid receptor (MOR) agonists are linked to the ?-arrestin pathway, while analgesia is tied to the G-protein pathway. Pathway specific or “biased” drug development can target G-protein specific agonists that avoid the negative consequences of ?-arrestin signaling activation and produce analgesia. Highly “biased” MOR agonists have promise as effective analgesics but devoid of opioid-induced adverse effects. Preclinical studies compared two compounds, MEB-1166 and MEB-1170, against Oliceridine and morphine. Both compounds displayed no respiratory depression, even at high doses, while morphine and Oliceridine significantly reduced respiratory function. In contrast to morphine, neither MEB-1166 nor MEB-1170 produced conditioned place preference, suggesting an absence of abuse liability. This study will characterize the pharmaceutical and pharmacological profiles and perform liability studies for these compounds.
3UH3DA047700-05S2  
Biased Mu-Opioid Receptor Analgesics to Prevent Overdose and Opioid Use Disorders Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA MEBIAS DISCOVERY, INC KUO, LAWRENCE C (contact); BARRETT, JAMES E Philadelphia, PA 2023
NOFO Title: Biased Mu-Opioid Receptor Analgesics to Prevent Overdose and Opioid Use Disorders
NOFO Number: PA-20-272
Summary:

There is an urgent need for a new generation of non-addictive, pain-relieving medications that do not cause problematic side effects like breathing problems or constipation. The overarching project is testing a new potential medication that interacts in a new way with the opioid system in human research participants. This supplement will help cover costs associated with the Safety Review Committee meeting required by the U.S. Food and Drug Administration.
1R61NS127286-01
Developing GPR37 Activators as Non-Opioid Pain Therapeutics Preclinical and Translational Research in Pain Management Development and Optimization of Non-Addictive Therapies to Treat Pain NINDS University of Texas Med BR LA, JUN-HO (contact); ALLEN, JOHN A; ZHOU, JIA Galveston, TX 2022
NOFO Title: HEAL Initiative: Planning Studies for Initial Analgesic Development [Small Molecules and Biologics] (R61 Clinical Trial Not Allowed)
NOFO Number: NS21-029
Summary:

Chronic pain from tissue injury often stems from long-term changes in spinal cord circuits that change nerve sensation. Reversing these changes may provide better pain therapeutics. Previous work in animal models showed that activating G protein-coupled receptor 37 (GPR37) dampens nerve signal intensity after long-term stimulation and alleviates pain behavioral responses. This project aims to validate GPR37 in the spinal cord as a useful target for new treatments for neuropathic pain. The work will facilitate screening and identification of new molecules that activate GPR37, which can then be tested for efficacy and safety in further research in animal models of pain.
1U18EB030609-01
Novel Implantable Device to Negate Post-Amputation Pain Preclinical and Translational Research in Pain Management Translating Discoveries into Effective Devices to Treat Pain NIBIB NOVAFLUX, INC. LABIB, MOHAMED E (contact); KATHJU, SANDEEP Princeton, NJ 2021
NOFO Title: HEAL Initiative: Translational Development of Devices to Treat Pain (U18 Clinical Trial Not Allowed)
NOFO Number: RFA-EB-18-003
Summary:

Approximately 3.6 million Americans live with an amputated extremity, and the majority of these individuals are likely to suffer from chronic post-amputation pain. There is no consensus as to a recommended therapy for such pain, and many treatments do not provide sufficient pain control. Some studies have shown effective pain suppression from delivering an anesthetic agent directly to an injured nerve. This research aims to develop a device that can be implanted near the injured nerves of an amputated limb to deliver an anesthetic. Findings from this preclinical study will optimize design and delivery features to maximize its effect on pain control for as long as possible without needing a drug refill. The research is expected to advance eligibility for further testing in large animals and humans.
1UH3NS115647-01A1
A Double-Blind, Randomized, Controlled Trial of Epidural Conus Medullaris Stimulation to Alleviate Pain and Augment Rehabilitation in Patients with Subacute Thoracic Spinal Cord Injury (SCI) Preclinical and Translational Research in Pain Management Translating Discoveries into Effective Devices to Treat Pain NINDS DUKE UNIVERSITY LAD, SHIVANAND P Durham, NC 2020
NOFO Title: HEAL Initiative: Clinical Devices to Treat Pain (UH3 Clinical Trial Optional)
NOFO Number: RFA-NS-19-018
Summary:

Pain is a major problem for spinal cord injury (SCI) patients that tends to persist and even worsen with time. No treatments are currently available to consistently relieve pain in SCI patients. This study will investigate the feasibility of Epidural Electrical Stimulation (EES) using the Abbott Proclaim? SCS system with two electrodes to treat neuropathic pain in patients with thoracic spinal cord injury. In this double-blind, prospective, randomized clinical trial, patients with subacute, traumatic, complete thoracic SCIs with American Spinal Injury Association (ASIA) Impairment Scale A will be randomized to receive either ?EES on? (treatment intervention) or ?EES off? (control intervention) of the target regions for pain control (lead overlying the spinal cord anatomy corresponding with their pain distribution) and neurorestoration (lead overlying the conus medullaris) as an adjunct to physical therapy. This study will help determine whether EES can help patients with SCI neuropathic pain and have more widespread clinical applicability.