Document Detail

A Phase 2 Study Evaluating the Efficacy and Safety of a Novel, Proprietary, Nano-Formulated, Lower Dose Oral Diclofenac.
MedLine Citation:
PMID:  23043637     Owner:  NLM     Status:  Publisher    
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.
Garen Manvelian; Stephen Daniels; Allan Gibofsky
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-10-8
Journal Detail:
Title:  Pain medicine (Malden, Mass.)     Volume:  -     ISSN:  1526-4637     ISO Abbreviation:  Pain Med     Publication Date:  2012 Oct 
Date Detail:
Created Date:  2012-10-9     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100894201     Medline TA:  Pain Med     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Wiley Periodicals, Inc.
Iroko Pharmaceuticals, LLC, Navy Yard Corporate Center, Philadelphia, Pennsylvania Premier Research Group International, LLC, Austin, Texas Hospital for Special Surgery, New York, New York, USA.
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