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Drug Evaluation

Meloxicam for Intravenous Use: Review of its Clinical Efficacy and Safety for Management of Postoperative Pain

, &
Pages 249-258 | Received 29 Sep 2020, Accepted 20 Nov 2020, Published online: 09 Dec 2020
 

Abstract

Meloxicam for intravenous use (meloxicam iv.) is a nanocrystal formulation with improved dissolution properties and shortened time to peak plasma concentrations versus oral meloxicam. In Phase III and IIIb trials, 30 mg once daily relieved pain following pre- or postoperative administration in orthopedic, abdominal and colorectal surgeries. Meloxicam iv. was associated with reduced opioid consumption, the clinical benefit of which remains unclear. The drug may be administered alone or in combination with other non-nonsteroidal anti-inflammatory drugs. In Phase III trials, it demonstrated adverse event profile similar to placebo, with nausea, constipation, vomiting and headache occurring most frequently. Meloxicam iv. does not appear to adversely affect platelet function or wound-healing parameters. No new safety signals were detected in the Phase IIIb studies.

Financial & competing interests disclosure

The publication was supported by Baudax Bio Inc., formerly Recro Pharma, Inc., PA, USA. RD Berkowitz is an employee of Phoenix Clinical Research who received funding from Recro/Baudax for conducting the 025 trial. RJ Mack and SW McCallum are employees and stockholders of Baudax Bio Inc., formerly Recro Pharma, Inc. The clinical trials and this publication were supported by Baudax Bio Inc., formerly Recro Pharma, Inc. Richard D Berkowitz, MD, is an employee of Phoenix Clinical Research, who conducted these trials. RJ Mack and SW McCallum are employees and stockholders of Baudax Bio Inc., formerly Recro Pharma, Inc. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Medical writing support was provided by Bret Fulton, RPh, and Mary Tom, PharmD, of The Medicine Group (PA, USA) and was funded by Baudax Bio Inc., formerly Recro Pharma, Inc.

Additional information

Funding

The publication was supported by Baudax Bio Inc., formerly Recro Pharma, Inc., PA, USA. RD Berkowitz is an employee of Phoenix Clinical Research who received funding from Recro/Baudax for conducting the 025 trial. RJ Mack and SW McCallum are employees and stockholders of Baudax Bio Inc., formerly Recro Pharma, Inc. The clinical trials and this publication were supported by Baudax Bio Inc., formerly Recro Pharma, Inc. Richard D Berkowitz, MD, is an employee of Phoenix Clinical Research, who conducted these trials. RJ Mack and SW McCallum are employees and stockholders of Baudax Bio Inc., formerly Recro Pharma, Inc. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Medical writing support was provided by Bret Fulton, RPh, and Mary Tom, PharmD, of The Medicine Group (PA, USA) and was funded by Baudax Bio Inc., formerly Recro Pharma, Inc.

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