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

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41DE028208-01
Agency Tracking Number: R41DE028208
Amount: $145,566.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIDCR
Solicitation Number: PA17-303
Solicitation Year: 2017
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-09-18
Award End Date (Contract End Date): 2019-09-17
Small Business Information
Greensboro, NC 27410-9351
United States
DUNS: 065907100
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (919) 843-3775
Business Contact
Phone: (919) 473-9296
Research Institution
United States

 Domestic Nonprofit Research Organization

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

* Information listed above is at the time of submission. *

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