A double-blind, randomized, parallel-group study of the pharmacokinetics and onset of action of Naprelan in patients following oral surgery

Abstract

Naprelan (Wyeth-Ayerst Laboratories, Philadelphia, Pennsylvania) is a novel formulation of naproxen sodium designed to offer both a rapid onset and a sustained duration of analgesia. Its onset of action was assessed in a double-blind, double-dummy, randomized, parallel-group study of 129 patients who had just undergone oral surgery to remove impacted third molars. Patients received Naprelan (500 mg or 1,000 mg), naproxen (500 mg), codeine (30 mg), or placebo. Both doses of Naprelan compared favorably with the established Naprosyn (formulation of naproxen; Syntex Laboratories, Inc., Palo Alto, California) with respect to onset of action, which occurred within 30 minutes in the majority of patients. The relative adverse effect profile showed that both Naprelan doses were as well tolerated as Naprosyn, codeine, and placebo. Pharmacokinetic and pharmacodynamic analysis confirmed the findings of previous Phase I studies in healthy subjects.