Arcato Laboratories Reports Positive Phase 1 Results for ARC-001 Gel
Patients undergoing third molar extractions reported a reduced reliance on opioids after receiving a single dose of Arcato Laboratories’ ARC-001 Gel. The Greenville-based biotech firm announced the successful completion of its first-in-human clinical study alongside a fully subscribed financing round, signaling a push toward non-narcotic dental analgesia.
The ARC-001 Gel formulation delivers a sustained release of benzocaine, lidocaine, and bupivacaine directly into the tooth socket. By eliminating the need for needles, the gel offers a localized delivery method designed to provide pain relief for up to one week. During the Phase 1 trial, data indicated that participants treated with the gel utilized rescue opioids half as often as the placebo group.
Dr. Thomas E. Van Dyke of the ADA Forsyth Institute noted that the product addresses a significant gap in oral surgery, where over 3 million procedures occur annually in the United States. Following these safety results, CEO Jeff Miller stated that the company is aligning its development path with the FDA’s May 2026 guidance for non-opioid analgesics. The company now plans to transition the proprietary treatment into Phase 2 and Phase 3 development.
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