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Pain Med. 2012 Nov;13(11):1491-8. doi: 10.1111/j.1526-4637.2012.01479.x. Epub 2012 Oct 8.

A phase 2 study evaluating the efficacy and safety of a novel, proprietary, nano-formulated, lower dose oral diclofenac.

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  • 1Iroko Pharmaceuticals, LLC, Navy Yard Corporate Center, Philadelphia, USA.

Abstract

BACKGROUND:

 Safety concerns associated with nonsteroidal anti-inflammatory drugs (NSAIDs) have prompted the development of new formulations that minimize adverse events (AEs) and maintain efficacy.

OBJECTIVES:

To determine the analgesic efficacy and safety of an investigational, proprietary, nano-formulated, oral diclofenac (nano-formulated diclofenac) compared with placebo in subjects with acute dental pain.

METHODS:

 A Phase 2, multisite, randomized, double-blind, single-dose, parallel-group, active- and placebo-controlled study was carried out in 202 subjects (18-50 years old) who had extraction of ≥2 third molars (≥1 had to be a fully or partially impacted mandibular third molar) and experienced moderate to severe pain intensity ≤6 hours postsurgery (NCT00985439). Subjects received nano-formulated diclofenac 35 mg or 18 mg, celecoxib 400 mg, or placebo. The primary efficacy variable was the sum of total pain relief (TOTPAR) over 0-12 hours (TOTPAR-12) after Time 0. Secondary end points included TOTPAR over 0-4 hours (TOTPAR-4), TOTPAR over 0-8 hours (TOTPAR-8), and time to onset of analgesia.

RESULTS:

Mean ± standard deviation TOTPAR-12 for nano-formulated diclofenac 35 mg and 18 mg, celecoxib, and placebo were 16.81 ± 12.76, 17.76 ± 13.76, 14.61 ± 15.05, and 5.65 ± 11.53, respectively (P < 0.001, nano-formulated diclofenac compared with placebo). Similar improvements were observed for TOTPAR-4, TOTPAR-8, mean time to first perceptible pain relief (P < 0.001), and peak relief (P < 0.05). Celecoxib treatment was not statistically different than placebo for these latter two parameters. Treatment-emergent AEs were similar across all treatment groups.

CONCLUSIONS:

Lower dose, nano-formulated diclofenac demonstrated good overall efficacy, prompt pain relief, and was well tolerated. These data suggest lower dose nano-formulated NSAIDs could be effective for acute pain and may potentially improve safety and tolerability as a result of using a lower overall dose.

Wiley Periodicals, Inc.

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