Non-Opiate Topical Formulations for Treating Pain Associated with Molar Extractions

Project Summary Abstract Most of the deaths from drug overdoses are driven by synthetic opioidsDentistry highly contributes to the opiate addiction epidemicFollowing dental surgeryof oral surgeons prescribe opiatesand most opiates are prescribed after wisdom teeth extractionthird molarto reduce pain caused by dry socketsApproximatelymillion surgical tooth extractions are performed onmillion patients each year in the USCurrentlydifferent medicaments and carrier systems are commercially available to treat these patients with little scientific evidence to guide the selection process for their use Thereforethe use of opiates for pain management unfortunately continues to be the go to treatment of choice for oral surgeonsThe goal of this STTR Phase I proposal is to develop a local treatment for pain associated with the extraction of teethsuch as third molars`wisdom teethandaposthat does not involve an opiateArcato has a history of commercializing products to serve specialty oral healthcare practitionerssuch as orthodontists and oral surgeonsArcatoandapos s first producta combination product named OraWaxtargets orthodontists and their patients with an effective treatment for oral mucosal discomfort caused by bracesOraWax is a patented time release formulation combining waxa non resorbable matrixbenzocaineand selected polymersThe innovation of this current STTR proposal is the formulation of a resorbable matrix containing an anesthetic agent that can be placed in a tooth socket following extraction with the goal of delivering the anesthetic in a sustained release manner over a period ofdaysThe Aims of this proposal are designed to reduce opiate use in patients with acute postoperative dental pain by providing an effective treatment that does not subject them to the risk of opioid addiction or the systemic toxicities of opiates and nonsteroidal anti inflammatory analgesicsNSAIDsIn Aimwe will employ a Design of ExperimentDOEapproach to yield an optimized resorbable matrix containing benzocainelidocaine or bupivacaineThe matrix will be comprised of poloxamer type co polymerssurfactants and cosurfactants that slowly erodethus allowing for the sustained release of the anesthetic agent after implantation in an alveolar socketThe selection of the prototyes to be advanced for in vivo evaluation will be based on in vitro drug release rate and rheometry of the matrixAimwill assess resorbability of the selected anestheticcontaining matrices in an alveolar extraction socket animal modelResorption will be assessed by recovering and weighing residual matricesdays after implantationmicro CT imaging and histological analysis will be used to assess if the implantation of the matrices results in bone loss or inflammationWe expect that successful development of this product and its implementation in dentistry oral surgery practice will lead to a significant reduction in the number of opiate prescriptions written for patients suffering from dry sockets or other painful sequelae resulting from dental proceduresFurthermorethe proposed technology is potentially applicable to other situations involving skeletal bleeding and paine gfollowing thoracic surgery Project Narrative Our goal is to develop a local treatment for pain following the extraction of teethsuch as third molars`wisdom teethandaposThis involves placement of a material in the empty tooth socket that slowly releases an anesthetic drug over a one week periodSuccessful development of this product and its implementation in dentistry oral surgery practice addresses the current opioid crisis in the US by leading to a significant reduction in the number of opioidnarcoticprescriptions written for patients suffering from dry sockets or other pain resulting from dental proceduresthus diminishing the potential for addiction