Investigation of topical intranasal cocaine for sinonasal procedures: A randomized, phase III clinical trial
International Forum of Allergy & Rhinology May 14, 2020
McGrath J, McGrath A, Burdett J, et al. - In this phase III, randomized, prospective, double‐blind, multicenter, single‐dose, placebo‐ and dose‐controlled, parallel‐group study, researchers tested the clinical effectiveness and safety of topical cocaine as part of the effort to gain regulatory approval from the United States Food and Drug Administration. In total, 925 patients were screened and a total of 648 patients were randomized: 95 to placebo; 275 to 4% RX0041‐002; and 278 to 8% RX0041‐002. Findings suggested that topical 4% and 8% cocaine is an effective anesthetic, which can be administered safely for nasal procedures. There were no cardiovascular adverse events (AEs), serious AEs, or deaths.
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