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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

Schachtel, Bernarda,b,*; Aspley, Suec; Shephard, Adrianc; Shea, Timothyc; Smith, Garyc; Sanner, Kathleenb; Savino, Laurieb; Rezuke, Jeanneb; Schachtel, Emilyb

doi: 10.1016/j.pain.2013.11.001
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Summary Using frequent measurements and analyses based on definite drug response, a new onset-of-action model identified the early onset of action of a flurbiprofen 8.75-mg lozenge.

ABSTRACT A new onset-of-action model was utilized to distinguish the pharmacologic activity of flurbiprofen 8.75 mg 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 3.5-4 hours 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.

aDepartment of Epidemiology and Public Health, Yale University School of Medicine, New Haven, CT, USA

bSchachtel Research Company, Jupiter, FL, USA

cReckitt Benckiser Healthcare International Ltd, Hull, UK

* Corresponding author at: Schachtel Research Company, Inc., 4300 So. US Highway One, Suite 203, Jupiter, FL 33477, USA. Tel.: +1 561 575 7330; fax: +1 561 575 7329.

E-mail address:bschachtel@SRCresearch.net

Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.

Article history:

Received 23 August 2013

Received in revised form 23 October 2013

Accepted 4 November 2013

© 2014 International Association for the Study of Pain
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