A Novel Opioid-Free Targeted Pain Control Method for Acute Post-Operative Localized Pain Related to Oral Surgical Procedures

Project Summary Abstract Drug addiction and overdose are a major problem in the USaccounting fordeaths inOverof drug overdose deaths involved misuse of prescription or illicit opioidsandof opioid prescriptions are written following oral surgical or dental proceduresApproximatelymillion wisdom teeth are removed annuallyA statistically significantabsolute risk increase in persistent opioid use and aincrease in the subsequent diagnosis of opioid abuse follows a single course of opiates following wisdom tooth extractionThereforethere is a compelling need to develop a front linenon opioid based acute pain management strategy for outpatient oral surgical proceduresLaunchPad Medical has developed TetraniteTNa novel bone regenerative mineral organic self setting adhesive biomaterialTN has been extensively studied in vivo in a canine jaw model and shown to be effective and well toleratedAdditionallypreliminary in vitro studies have shown that medication can be incorporated into TN formulations and released over timeand it is well established that the release profile of a target drug can be tailored to time dose curve using conventional time release technology such as passive diffusionAdministering locally acting analgesicse gnaproxenlocal anestheticse gbupivacaineand or gabapentinoidse gpregabalinpassively released over theday window when pain relief is most neededis a strong and innovative strategy for limiting acute postoperative pain following wisdom tooth removalwhile employing TN as a filler sealant will allow for simultaneous occlusion of environmental irritants to the bone woundthus preventing osteitis and allowing bone regenerationIn this Phase I projectwe will demonstrate that drug loaded TN can be a novel route to providing localized and time release pain medication following wisdom tooth extraction by determining the release profile of various pain medications from TN at different concentrationsAim Iverifying the consistency of TN handling and exotherm in compounded formulationsAim IIand verifying the biocompatibility of TN drug formulation in vitro using human osteoblastsAim IIIThe ability to release pain therapeutics in a controlled fashion and directly at the site of injury offers improved pain control following oral surgical procedures without exposing the patient to opioidsIn additionthis novel approach to pain management can be extended to more invasive orthopedic procedures such as joint replacementspinal fusions or reconstructive trauma surgeryIn Phase II we will conduct an in vivo study to assess efficacy of medicated TN to address post operative pain following wisdom tooth odontectomyoptimize incorporation and release of medications in TN formulationsdevelop cGMP manufacturing process for the compounded productand ultimately conduct clinical trials for bone void filler using medicated TN Project Narrative Overof drug overdose deaths involve misuse of prescription or illicit opioidsandof opioid prescriptions are written following oral surgical procedures such as wisdom teeth removalLaunchPad Medical has developed an innovative bone regenerative mineral organic self setting adhesive biomaterialTetranitewhich has been shown to be biocompatiblewell tolerated and efficacious in dental proceduresThe proposed study will demonstrate that various pain therapeutics can be loaded into Tetranite and released in a controlled fashion and directly at the site of injurydevelopment of this technology would make available to the oral surgeon a novel front linenon opioid based acute pain management strategy