Disclosure: Garen Manvelian, MD, is a consultant for Iroko Pharmaceuticals, LLC. Allan Gibofsky, MD, has participated in a scientific advisory board for Iroko Pharmaceuticals, LLC. Stephen Daniels, DO, is an employee of Premier Research Group International, LLC, which was contracted to complete this Phase 2 clinical trial.
Original Research Article
A Phase 2 Study Evaluating the Efficacy and Safety of a Novel, Proprietary, Nano-Formulated, Lower Dose Oral Diclofenac
Article first published online: 8 OCT 2012
Wiley Periodicals, Inc.
Volume 13, Issue 11, pages 1491–1498, November 2012
How to Cite
Manvelian, G., Daniels, S. and Gibofsky, A. (2012), A Phase 2 Study Evaluating the Efficacy and Safety of a Novel, Proprietary, Nano-Formulated, Lower Dose Oral Diclofenac. Pain Medicine, 13: 1491–1498. doi: 10.1111/j.1526-4637.2012.01479.x
- Issue published online: 14 NOV 2012
- Article first published online: 8 OCT 2012
Vol. 14, Issue 10, 1615, Article first published online: 16 OCT 2013
- Acute Pain;
- Phase 2;
- SoluMatrix Technology
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.