Efficacy and safety of single-dose DFN-15 for treatment of acute postsurgical dental pain: a randomized, double-blind, placebo-controlled study

Abstract

The analgesic efficacy and safety of DFN-15, a new oral liquid formulation of celecoxib with more rapid absorption than the capsule, were evaluated in the treatment of acute pain in adult patients after dental surgery. In this randomized, double-blind, placebo-controlled, dose-ranging study, 120 otherwise healthy adults who underwent the extraction of bilateral impacted mandibular third molar teeth and experienced moderate to severe pain postsurgery were randomly assigned, in a 1:1:1:1 ratio, to receive one dose of either placebo or DFN-15 at 3 doses: 62.5, 125, and 250 mg. Participants were evaluated at prespecified time points over 8 hours after study drug administration, using several instruments, including the 11-point Numerical Pain Rating Scale, 5-point Pain Relief Scale, and 5-point Treatment Satisfaction Scale. Rescue analgesic (oxycodone / acetaminophen) was permitted. The primary endpoint was the summed pain intensity difference (SPID) over the 6-hour postdose period (SPID6), which was compared between each DFN-15 dose and placebo using analysis of covariance. Other assessments of pain relief, use of rescue medication, and safety were also analyzed. All 3 doses of DFN-15 were significantly superior to placebo in SPID6 (least square mean difference over placebo: -756.6, -1120.7, and -1355.1, P < 0.0001 for all comparisons). In addition, DFN-15 was generally superior to placebo in other endpoints, including reduction of pain intensity, speed and magnitude of pain relief, treatment satisfaction, and rescue medication use. DFN-15 was similar to placebo in the incidence of adverse events with no apparent dose-related effects.

Trial registration: ClinicalTrials.gov NCT03554772.

Conflict of interest statement

N. Singla and T. Bertoch received payments from Dr. Reddy's Laboratories to conduct this study. S. Shenoy and S. Munjal are employees of Dr. Reddy's Laboratories.

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

Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the International Association for the Study of Pain.

Figures

Figure 1.

Mean pain intensity difference (PID) scores over time (mITT population). mITT, modified intent-to-treat.

Figure 2.

Mean SPID values from T0 through 2, 4, 6, and 8 hours postdose (mITT population). mITT, modified intent-to-treat; NPRS, Numerical Pain Rating Score; PID, pain intensity difference; SPID, summed pain intensity difference; T0, time of study drug administration. PID were defined as NPRS at hour x−baseline NPRS, therefore negative PID indicates less pain and larger negative SPID indicates larger benefit.

Figure 3.

Kaplan–Meier curve for time to meaningful pain relief (mITT population). mITT, modified intent-to-treat. Subjects receiving rescue medication or discontinuing the study before reporting meaningful pain relief were censored at 8 hours.