Investigation of topical intranasal cocaine for sinonasal procedures: a randomized, phase III clinical trial.

Background: The objective of this trial was to demonstrate the clinical efficacy and safety of topical cocaine as part of the effort to gain regulatory approval from the United States Food and Drug Administration.

Methods: This phase III, randomized, prospective, double-blind, multicenter, single-dose, placebo- and dose-controlled, parallel-group study aimed to evaluate the safety and efficacy of topical intranasal cocaine (RX0041-002). A total of 925 subjects were screened and a total of 648 subjects were randomized: 95 to placebo; 275 to 4% RX0041-002; and 278 to 8% RX0041-002.