Onset of action of a lozenge containing flurbiprofen 8.75 mg: a randomized, double-blind, placebo-controlled trial with a new method for measuring onset of analgesic activity.
A new onset-of-action model was utilized to distinguish the pharmacologic activity of flurbiprofen 8.75mg delivered in a lozenge from the demulcent effect of the lozenge base. In a randomized, double-blind, placebo-controlled trial, patients with sore throat rated pain on a Sore Throat Pain Intensity Scale before taking one flurbiprofen or placebo lozenge and at frequent (2-minute) intervals over the first hour after treatment. Further ratings of the Sore Throat Pain Intensity Scale and other patient-reported outcomes (difficulty swallowing, swollen throat, pain relief) were obtained at varying intervals over 6 hours. Onset of pharmacologic activity was defined as the median time of first perceived pain reduction if a patient reported clinically meaningful (at least moderate) relief. The conventional method of comparing mean treatment responses at each time point was also implemented. Demulcent action was detected at the first 2-minute assessment. By the new method, 102 flurbiprofen-treated patients were identified as first perceiving pain relief at 12 minutes, compared with >120 minutes by 102 patients using placebo (P<0.001). By the conventional method, mean percentage pain reduction for flurbiprofen 8.75 mg was first significantly differentiated from placebo at 26 minutes (P<0.05). Efficacy of flurbiprofen lozenge was demonstrated for 3.5-4hours on the 4 patient-reported outcomes (all P<0.05 compared with placebo). There were no serious adverse events. This patient-centered onset-of-action model identifies the initiation of pain relief in patients who are definite drug responders, here demonstrating that a flurbiprofen 8.75-mg lozenge provides early relief of sore throat.
Department of Epidemiology and Public Health, Yale University School of Medicine, New Haven, CT, USA Schachtel Research Company, Jupiter, FL, USA Reckitt Benckiser Healthcare International Ltd, Hull, UK.
Bernard
B
Schachtel
Sue
S
Aspley
Adrian
A
Shephard
Timothy
T
Shea
Gary
G
Smith
Kathleen
K
Sanner
Laurie
L
Savino
Jeanne
J
Rezuke
Emily
E
Schachtel
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000700:Analgesics / Q000008:administration & dosage*; D004311:Double-Blind Method; D016503:Drug Delivery Systems / Q000379:methods; D005260:Female; D005480:Flurbiprofen / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D010146:Pain / Q000175:diagnosis / Q000188:drug therapy*; D010147:Pain Measurement / Q000187:drug effects* / Q000379:methods; D010612:Pharyngitis / Q000175:diagnosis / Q000188:drug therapy*; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
D000700:Analgesics; D005480:Flurbiprofen
Acute pain; Flurbiprofen; NSAID; Onset of action; Sore throat