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In adults scheduled to undergo dental surgery, a single dose of DFN-15 (at 62.5 mg to 250 mg) can effectively and safely alleviate moderate to severe pain.
Compared to placebo, DNF-15 (newly developed oral liquid formulation of celecoxib) was superior in terms of treatment satisfaction, decrease in pain intensity, magnitude and speed of pain mitigation, and rescue medication use in people suffering from acute dental pain after surgery. In this double-blind, randomized, dose-ranging, placebo-controlled study, Neil Singla et al. aimed to determine the efficacy and safety of DNF-15 for the management of acute postsurgical dental pain.
Overall, 120 subjects who experienced pain after extraction of bilateral impacted mandibular third molar teeth were recruited. Participants were randomly allocated in a 1:1:1:1 ratio to get 1 dose of either placebo or DNF-15 at 3 doses (62.5 mg, 125 mg, 250 mg). At prespecified time points after study drug administration, participants were evaluated using 5-point Pain Relief Scale, the 11-point Numerical Pain Rating Scale, and 5-point Treatment Satisfaction Scale. Oxycodone/acetaminophen were used as rescue analgesics.
Utilizing the analysis of covariance, the summed pain intensity difference (SPID, major outcome) over six-hour postdose period (SPID6) was evaluated between each dose of DNF-15 and placebo. The usage of rescue medication, safety, and pain reduction were also analyzed. In terms of SPID6, DFN-15 (all three doses) was superior to placebo, as shown in Table 1:
Notably, the magnitude and speed of pain relief, use of rescue medication, decrease in intensity of pain, and satisfaction of treatment was better in DNF-15 recipients than placebo recipients. Regarding the occurrence of adverse events, DFN-15 was similar to placebo. However, no dose-associated effects were reported. Hence, DFN-15 offers promising therapeutic advantages in terms of early pain alleviation and more rapid onset of analgesia.
Pain
Efficacy and safety of single-dose DFN-15 for treatment of acute postsurgical dental pain: a randomized, double-blind, placebo-controlled study
Neil Singla et al.
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