PMID- 29497329 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220321 IS - 1178-7090 (Print) IS - 1178-7090 (Electronic) IS - 1178-7090 (Linking) VI - 11 DP - 2018 TI - Evaluation of the safety and efficacy of an intravenous nanocrystal formulation of meloxicam in the management of moderate-to-severe pain after bunionectomy. PG - 383-393 LID - 10.2147/JPR.S149879 [doi] AB - OBJECTIVE: This randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of an intravenous (IV) nanocrystal formulation of meloxicam in subjects with moderate-to-severe pain following a standardized unilateral bunionectomy. METHODS: Fifty-nine subjects aged 18-72 years were randomized to receive doses of either 30 mg (n=20) or 60 mg (n=20) meloxicam IV or placebo (n=19), administered once daily as bolus IV injections over 15-30 seconds (two or three doses). Safety, the primary objective, was assessed by physical examination, clinical laboratory tests, and the incidence of adverse events (AEs). Efficacy was evaluated by examining summed pain intensity differences over the first 48 hours (SPID(48)) using analysis of covariance models. Use of opioid rescue analgesic agents was evaluated. RESULTS: Generally, AEs were mild-to-moderate in intensity, and their incidence was similar across the three treatment groups. No serious AEs were reported; there were no withdrawals due to AEs, including injection-related AEs. The estimated effect size for SPID(48) versus placebo was 1.15 and 1.01 for meloxicam IV doses 30 mg and 60 mg, respectively (P/=30% and >/=50% overall reduction in pain from baseline after 6 and 24 hours were significantly higher with meloxicam IV 30 mg doses versus placebo, but not with meloxicam IV 60 mg doses. The time to first use of rescue medication was significantly longer versus placebo with meloxicam IV 60 mg (P<0.05), but not with meloxicam IV 30 mg doses. CONCLUSION: Meloxicam IV was generally safe and well tolerated in subjects with moderate-to-severe post-bunionectomy pain. Once-daily administration of meloxicam IV 30 mg and 60 mg exhibited rapid onset of analgesia (as early as 15 minutes) with maintenance of analgesic effect for two consecutive 24-hour periods. FAU - Gottlieb, Ira J AU - Gottlieb IJ AD - Chesapeake Research Group, Pasadena, MD, USA. FAU - Tunick, Deborah R AU - Tunick DR AD - Chesapeake Research Group, Pasadena, MD, USA. FAU - Mack, Randall J AU - Mack RJ AD - Recro Pharma, Inc., Malvern, PA, USA. FAU - McCallum, Stewart W AU - McCallum SW AD - Recro Pharma, Inc., Malvern, PA, USA. FAU - Howard, Campbell P AU - Howard CP AD - Howard Medical Consulting for the Pharmaceutical Industry, Yardley, PA, USA. FAU - Freyer, Alex AU - Freyer A AD - Recro Pharma, Inc., Malvern, PA, USA. FAU - Du, Wei AU - Du W AD - Clinical Statistics Consulting, Blue Bell, PA, USA. LA - eng PT - Journal Article DEP - 20180216 PL - New Zealand TA - J Pain Res JT - Journal of pain research JID - 101540514 PMC - PMC5819580 OTO - NOTNLM OT - COX-2 inhibitor OT - bunionectomy OT - efficacy OT - meloxicam IV OT - postoperative pain OT - safety COIS- Disclosure Portions of this manuscript have previously been presented at the 2016 PAINWeek National Conference; September 6-10th, 2016. Ira J Gottlieb and Deborah R Tunick are employees of Chesapeake Research Group, which conducted this trial. Wei Du and Campbell P Howard received consultancy fees from Recro Pharma, Inc., Malvern, PA, USA. Randall J Mack, Stewart W McCallum, and Alex Freyer are employees and security holders of Recro Pharma, Inc., Malvern, PA, USA. The authors have no other conflicts of interest to declare with respect to this work. EDAT- 2018/03/03 06:00 MHDA- 2018/03/03 06:01 PMCR- 2018/02/16 CRDT- 2018/03/03 06:00 PHST- 2018/03/03 06:00 [entrez] PHST- 2018/03/03 06:00 [pubmed] PHST- 2018/03/03 06:01 [medline] PHST- 2018/02/16 00:00 [pmc-release] AID - jpr-11-383 [pii] AID - 10.2147/JPR.S149879 [doi] PST - epublish SO - J Pain Res. 2018 Feb 16;11:383-393. doi: 10.2147/JPR.S149879. eCollection 2018.