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

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.