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

Arcato实验室公司正在推进LBB-111的开发，这是一种治疗癌症的非阿片类药物 外科手术后急性牙痛的处理。尽管目前存在阿片类药物危机，但阿片类药物处方如下 拔除智齿(拔除第三颗磨牙)仍然是牙医的普遍做法，部分原因是 可能会出现痛苦的并发症，如干眼圈。大约有1000万名患者接受了手术 每年在美国拔牙，其中许多是青少年和年轻人，以前没有接触过 对阿片类药物的使用，而且最有可能滥用或误用阿片类药物。为了满足这种医疗和社会需求 为了管理和治疗急性牙痛，我们开发了LBB-111，这是一种新型的非成瘾药物。LBB-111是一种 三种麻醉药的专有可吸收乳剂，在拔牙过程中直接给药 到拔牙插座，在那里它可以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、稳定性和药理特性在第一阶段得到证实。 第二阶段的目标是完成LBB-111的研究性新药(IND)研究，包括 建立制造和质量控制流程(目标1)，并对比格犬进行体内毒理学研究 动物模型(目标2)。这项提议的目标的成功完成将推动LBB-111 IND提交，并在人类研究中第一。FDA未来对LBB-111的批准和商业化将 加速将其作为牙科和口腔外科实践中多模式护理战略的一部分加以实施， 预计将减少或完全消除为拔除第三磨牙开阿片类药物的做法。

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.