Safety and Efficacy Study of NTC-510 to Treat Pain Following Dental Surgery of Third Molars

This is a Phase 2a, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy, concentration versus efficacy relationship, and safety of NTC-510 and NTC-510A at doses of 2.0, 1.0, and 0.5 mg. The study will consist of 4 phases: screening (within 28 days before check-in), check-in (before surgery on Day 1), treatment (surgery, randomization, and treatment with study drug on Day 1), and follow up (Days 6 to 8). During the screening phase, screening procedures will be performed, subject eligibility will be determined, and written consent will be obtained. Subjects will then undergo dental surgery to extract 1 or 2 third molars (with at least 1 partial or complete bony mandibular extraction). The impaction score (\[1\] erupted in tissue, \[2\] broken soft tissue, \[3\] partial bony impaction, and \[4\] full bony impaction) will be collected for statistical adjustment should there be randomization imbalance. The surgery will be conducted according to standard clinical unit procedures.