(231) Analgesic onset of a novel liquid-gel formulation of diclofenac potassium in post surgical dental pain

Abstract

Diclofenac Potassium Soft Gelatin Capsule (DPSGC) is a novel liquid formulation of diclofenac potassium encapsulated in a soft gelatin capsule using patented ProSorb technology designed to facilitate rapid and consistent gastrointestinal tract absorption. We evaluated the time to analgesic onset of the lowest effective DPSGC dose (25 mg) in two postoperative dental pain studies including a post-hoc analysis of time to “confirmed perceptible pain relief.” A total of 514 adult subjects were enrolled in these multicenter, parallel group, double-blind, placebo-controlled studies. Subjects were randomized to receive single doses of DPSGC 25 mg, 50 mg, 100 mg or placebo. Pain was assessed at baseline and for 6 hours after dosing. Time to onset of perceptible and meaningful pain relief was recorded using the two-stopwatch method. The post-hoc analysis of confirmed perceptible pain relief included only subjects achieving perceptible pain relief (1st click) who also reported clinically meaningful pain relief (2nd click). In addition, the Dental Pain Relief Rating (DPRR) scale was used to assess pain relief (0 = no relief, 4 = complete relief). In each study a statistically significantly greater number of subjects achieved confirmed perceptible pain relief in the DPSGC 25 mg groups [83% (52/63) and 81% (51/63), respectively] compared to placebo [27% (18/68) and 28% (17/61), respectively]. The median time to onset of confirmed perceptible pain relief was 24 and 27 minutes for subjects receiving DPSGC 25 mg and was Not Calculable in the placebo groups since less than 50% of placebo subjects achieved confirmed relief. In each study, the mean pain relief intensity difference (PRID) and mean DPRR for the DPSGC 25 mg group were statistically significantly greater than placebo at 30 minutes. These results indicate that DPSGC is an effective non-opioid analgesic with rapid onset of pain relief occurring within 30 minutes. Supported by Xanodyne Pharmaceuticals.