Arcato's ARC-001 Gel Meets Safety Endpoint in Phase 1 Trial, Showing Durable Analgesia After Third Molar Surgery
核心洞察
Arcato Laboratories (搜索) reported topline results from its first-in-human Phase 1 study of ARC-001 Gel (搜索), meeting the primary safety endpoint in patients following third molar extraction surgery.
Exploratory analyses suggest a single dose of ARC-001 Gel (搜索) reduces post-operative pain within the first 24 hours and may provide relief for up to one week.
Patients on placebo self-reported a need for opioids twice as often as those treated with ARC-001 Gel (搜索) to manage pain.
Arcato Laboratories (搜索), Inc. announced successful topline results from its first-in-human Phase 1 study of ARC-001 Gel (搜索) in patients following third molar (wisdom tooth) extraction surgery, alongside the closing of its first round of financing. The Phase 1 primary endpoint of safety was achieved, supporting further Phase 2/3 development.
ARC-001 Gel (搜索) is a novel, proprietary, sustained-release single-dose gel formulation combining three well-characterized, non-addictive anesthetics: Benzocaine, Lidocaine, and Bupivacaine. The formulation allows for one-time local administration directly into the tooth socket following surgical extraction, with a pharmacokinetic profile supporting the potential for pain relief for up to 7 days. Notably, ARC-001 Gel does not require an injection or a needle, as the gel is easily administered directly into the extraction socket.
Exploratory Efficacy Signals
Exploratory efficacy endpoints suggest pain reduction within the first 24 hours and that a single dose of ARC-001 Gel (搜索) 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.
Addressing an Unmet Need in Oral Surgery
"The dental and oral surgery community welcome the work Arcato is doing to develop a pain treatment specifically for oral health. ARC-001 Gel (搜索) 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 US having third molar surgery, new pain management options are needed. While progress has been made in reducing post-operative 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 (搜索).
Regulatory Alignment and Next Steps
"Our clinical results demonstrate that ARC-001 Gel (搜索) 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 (搜索).