Non-opiate topical formulations for treating pain associated with molar extractions

用于治疗拔牙相关疼痛的非阿片类局部制剂

基本信息

批准号：
10366096
负责人：
Alan Parr
金额：
$ 71.56万
依托单位：
ARCATO LABORATORIES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-09-18 至 2024-02-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10366096
关键词：
Acetaminophen Acute Acute Pain Acute pain management Address Adolescent Adolescent and Young Adult Adult Advanced Development Alveolar periostitis American Dental Association Anesthetics Animal Model Animals Appearance Area Caring Clinical Clinical Chemistry Clinical Research Clinical Trials Collaborations Contracts Cream Cyclic GMP Data Dentists Development Dose Drug Formulations Emulsions Engineering Ensure Euthanasia Evaluation Excision Exposure to Formulation Future Germicide Hematology Histopathology Humidity In Vitro Indium-111 Investigational Drugs Investigational New Drug Application Laboratories Local Anesthetics Measures Medical Medication Management Mouthwash National Institute of Dental and Craniofacial Research Non-Steroidal Anti-Inflammatory Agents Operative Surgical Procedures Opiate Addiction Opioid Oral Surgical Procedures Oral mucous membrane structure Oxycodone Pain Pain management Patients Pharmaceutical Preparations Pharmacologic Substance Pharmacology Phase Placebo Control Placebos Pluronics Postoperative Pain Postoperative Period Process Property Quality Control Reporting Rheology Risk Safety Site Systems Analysis Therapeutic Time Tissue Harvesting Tooth Extraction Tooth Socket Toothache Toxicology Viscosity addiction base combat commercialization dental surgery dosage drug development first-in-human good laboratory practice in vivo multidisciplinary multimodality non-opioid analgesic novel novel therapeutics opioid abuse opioid epidemic opioid misuse oral pain pain relief phase 1 study phase 2 study pill prescription opioid standard of care success systemic toxicity third molar extraction wisdom tooth

项目摘要

Arcato Laboratories, Inc. is advancing the development of LBB-111, a non-opioid medication for the management of acute, post-surgical dental pain. Despite the current opioid crisis, opioid prescription following removal of the wisdom teeth (third molar extraction) remains a common practice among dentists, due in part to the potential for painful complications such as dry sockets. Approximately ten million patients undergo surgical tooth extraction in the U.S. each year, many of whom are adolescents and young adults with no prior exposure to opioid medications, and most at risk for opioid abuse or misuse. To meet this medical and societal need for novel, non-addictive medications to manage and treat acute dental pain, we developed LBB-111. LBB-111 is a proprietary resorbable emulsion of three anesthetic drugs that is administered, during tooth extraction, directly to the extraction socket, where it delivers sustained, post-operative pain relief for four to seven days post-surgery. The preliminary safety, stability, and pharmacological properties of LBB-111 were demonstrated in Phase I. The objectives of Phase II are to complete Investigational New Drug (IND)-enabling studies of LBB-111, including establishing manufacturing and quality control processes (Aim 1), and in vivo toxicology studies in a beagle animal model (Aim 2). The successful completion of the Aims of this proposal will advance LBB-111 towards IND submission, and first in human studies. Future FDA approval and commercialization of LBB-111 will accelerate its implementation as part of a multi-modal care strategy in dental and oral surgery practices, which is expected to reduce, or completely eliminate, the practice of prescribing opioids for third molar extractions.

Arcato Laboratories, Inc. 正在推进 LBB-111 的开发，这是一种非阿片类药物，用于治疗急性手术后牙痛的治疗。尽管当前存在阿片类药物危机，但阿片类药物处方如下拔除智齿（拔除第三磨牙）仍然是牙医的常见做法，部分原因是潜在的痛苦并发症，例如干槽症。大约一千万患者接受手术美国每年都有拔牙事件，其中许多是以前没有接触过拔牙的青少年和年轻人阿片类药物，并且最有阿片类药物滥用或误用的风险。为了满足这一医疗和社会需求我们开发了 LBB-111，用于管理和治疗急性牙痛的新型非成瘾药物。 LBB-111 是一种三种麻醉药物的专有可吸收乳液，在拔牙过程中直接给药到达拔牙槽，在术后四到七天内提供持续的术后疼痛缓解。 LBB-111的初步安全性、稳定性和药理特性已在一期试验中得到证实。第二阶段的目标是完成 LBB-111 的研究性新药 (IND) 启用研究，包括建立生产和质量控制流程（目标 1），并在比格犬中进行体内毒理学研究动物模型（目标 2）。该提案目标的成功完成将推动 LBB-111 朝着 IND 提交，并且是人类研究中的首次。 LBB-111 未来 FDA 的批准和商业化将作为牙科和口腔外科实践中多模式护理战略的一部分，加快其实施，预计将减少或完全消除为拔除第三磨牙而开阿片类药物的做法。