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Opioid-sparing Effects of SoluMatrix Indomethacin in a Phase 3 Study in Patients With Acute Postoperative Pain

Gharibo, Christopher G. MD*; Argoff, Charles MD; Markenson, Joseph A. MD; Webster, Lynn R. MD§; Nezzer, Jennifer MS; Solorio, Daniel BA; Lauterio, Melanie PhD; Young, Clarence MD

doi: 10.1097/AJP.0000000000000525
Original Articles

Objectives: To report the opioid-sparing effects of SoluMatrix indomethacin, developed using SoluMatrix Fine Particle Technology, in a phase 3 study in patients with acute pain following bunionectomy.

Methods: This phase 3, placebo-controlled study randomized 462 patients with moderate-to-severe pain following bunionectomy surgery to receive SoluMatrix indomethacin 40 mg 3 times daily, SoluMatrix indomethacin 40 mg twice daily, SoluMatrix indomethacin 20 mg 3 times daily, celecoxib 400-mg loading dose followed by 200 mg twice daily, or placebo. Patients were permitted to receive opioid-containing rescue medication throughout the study. The proportion of patients who used rescue medication and the amount of rescue medication used on the first (0 to 24 h) and second (>24 to 48 h) days following initial dose of study medication, as well as time to first rescue medication use, were assessed.

Results: Significantly fewer patients who received SoluMatrix indomethacin 40 or 20 mg 3 times daily used opioid-containing rescue medication on day 1 compared with those receiving placebo (P≤0.034), and fewer patients in all active treatment groups used rescue medication during the second day compared with those in the placebo group (P<0.001). All active treatment groups used significantly fewer rescue medication tablets on days 1 and 2 following randomization compared with placebo (P<0.001). The most common adverse events were nausea, postprocedural edema, and headache.

Discussion: SoluMatrix indomethacin was associated with opioid-sparing effects in patients with acute postoperative pain.

*Department of Anesthesiology, Pain Management, New York University Langone Medical Center

Hospital for Special Surgery, New York

Albany Medical College, Neurology Group, Albany, NY

§PRA Health Sciences, Salt Lake City, UT

Premier Research, Austin, TX

Iroko Pharmaceuticals, LLC, Philadelphia, PA

C.G.: is a consultant and is a member of the speakers’ bureau for Iroko Pharmaceuticals, LLC; Depomed Inc. Newark, CA; Teva Pharmaceutical Industries Ltd Petah Tivka, Israel; Pernix Therapeutics, Morristown, NJ; Mallinckrodt Pharmaceuticals Surrey, United Kingdom; and AstraZeneca plc, Cambridge, UK. C.A.: is a member of the Iroko Pharmaceuticals, LLC, speakers’ bureau. J.A.M.: is a member of the speakers’ bureau of AbbVie North Chicago, IL; Amgen, Thousand Oaks, CA; Bristol-Myers Squibb Company New York, NY; Iroko Pharmaceuticals, LLC; Antares Pharma, Ewing Township, NJ; Pfizer New York, NY; Celgene Summit, NJ; and Janssen Beerse, Belgium; and is a member of advisory boards for AbbVie North Chicago, IL; Amgen, Thousand Oaks, CA; Pfizer, Inc, New York, NY; and Iroko Pharmaceuticals, LLC, Philadelphia, PA. L.W.: has received consulting fees from BioDelivery Sciences International Inc Raleigh, NC; Grunenthal USA Inc. Morristown, NJ; Mallinckrodt Pharmaceuticals Surrey, United Kingdom; Depomed Inc. Newark, CA; Egalet Corp. Wayne, PA; Inspirion Pharmaceuticals Bedminster, NJ; INSYS Therapeutics Inc. Phoenix, AZ; Orexo AB (publ); Pfizer Inc. New York, NY; Teva Pharmaceutical Industries Ltd Petah Tivka, Israel; Trevena Inc. King of Prussia, PA; AstraZeneca plc Cambridge, UK; Bristol-Myers Squibb Company New York, NY; Cara Therapeutics Stamford, CT; CVS/Caremark, Woonsocket, Rhode Island; Jazz Pharmaceuticals plc Dublin, Republic of Ireland; Kaleo Inc. Kaleo Pharma, Inc, Richmond, VA; Nektar Therapeutics San Francisco, CA; Nevro Corp Redwood City, CA; Proove Biosciences Irvine, CA; Signature Therapeutics Inc. San Diego, CA; and Synchrony Healthcare Group, LLC, West Chester, PA. J.N.: is an employee of Premier Research Austin, TX, which was contracted by Iroko Pharmaceuticals, LLC, to conduct the phase 3 clinical study. D.S.: is an employee of Iroko Pharmaceuticals, LLC. M.L. and C.Y.: were employees of Iroko Pharmaceuticals, LLC at the time this study was conducted.

Reprints: Clarence Young, MD, Velicept Therapeutics, 101 Lindenwood Drive, Suite 125, Malvern, PA 19355 (e-mail:

Received August 18, 2016

Received in revised form May 12, 2017

Accepted May 31, 2017

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