Arcato Advances Non-Opioid Oral Pain Treatment

 Arcato Laboratories, Inc. (https://www.arcato-labs.com/) today simultaneously announced successful top line results from its first-in-human Phase 1 study of ARC-001 Gel in patients following third molar (wisdom tooth) extraction surgery, as well as the closing of its first round of financing.

ARC-001 Gel is a novel, proprietary, sustained-release, single-dose gel formulation combining three well-characterized, non-addictive anesthetics: benzocaine, lidocaine, and bupivacaine. The novel formulation of ARC-001 Gel allows for a one-time local administration into the tooth socket following surgical extraction, with a pharmacokinetic profile supporting the potential for pain relief for up to 7 days. ARC-001 Gel does not require an injection or a needle; the gel is easily administered directly into the extraction socket.

The Phase 1 primary endpoint of safety was achieved, supporting further Phase 2/3 development. Exploratory efficacy endpoints suggest pain reduction within the first 24 hours and that a single dose of ARC-001 Gel may provide pain relief for up to one week. Further exploratory analyses demonstrated that patients on placebo self-reported a need for opioids twice as often as those on ARC-001 Gel to manage pain.

“The dental and oral surgery community welcomes the work Arcato is doing to develop a pain treatment specifically for oral health. ARC-001 Gel is a unique approach to local pain management after third molar surgery, combining three well-known anesthetics in a novel formulation. With more than 3 million patients per year in the U.S. having third molar surgery, new pain management options are needed. While progress has been made in reducing postoperative opioid use, there is much work to be done,” said Dr. Thomas E. Van Dyke, DDS, PhD, Vice President of Clinical and Translational Research at the ADA Forsyth Institute.

“Our clinical results demonstrate that ARC-001 Gel is an exciting new approach to managing oral pain. We are actively engaged with the FDA, closely aligned with their May 2026 draft development guidance for non-opioid analgesics. Moreover, I would like to thank the Arcato team, as well as our investors, at this exciting milestone,” said Jeff Miller, Chief Executive Officer of Arcato Laboratories.