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Curr Med Res Opin. 2015 Dec;31(12):2331-43. doi: 10.1185/03007995.2015.1112772.

Efficacy and safety of low-dose SoluMatrix meloxicam in the treatment of osteoarthritis pain: a 12-week, phase 3 study.

Author information

1
a a University of California, David Geffen School of Medicine , Los Angeles , CA , USA.
2
b b University of Maryland School of Medicine , Baltimore , MD , USA.
3
c c Hospital for Special Surgery , New York , NY , USA.
4
d d Summit Analytical LLC , Denver , CO , USA.
5
e e Iroko Pharmaceuticals, LLC , Philadelphia , PA , USA.

Abstract

OBJECTIVE:

Nonsteroidal anti-inflammatory drugs (NSAIDs) such as meloxicam are commonly used to treat osteoarthritis (OA) but are associated with potentially serious dose-related adverse events (AEs). SoluMatrix meloxicam has been developed with the goal of enabling effective treatment at low doses. This phase 3 study evaluated the efficacy and safety of low-dose SoluMatrix meloxicam capsules 5 mg and 10 mg administered once daily for 12 weeks in patients with OA-related pain.

RESEARCH DESIGN AND METHODS:

This randomized, double-blind study enrolled patients ≥40 years of age with confirmed hip or knee OA (Kellgren-Lawrence grade II-III) who were chronic users of NSAIDs and/or acetaminophen for OA pain and had Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale mean scores ≥40 mm. Eligible patients experienced an OA pain flare (defined as a ≥15 mm increase in the WOMAC pain subscale score) following discontinuation of NSAIDs/acetaminophen. Patients were randomized to receive once-daily SoluMatrix meloxicam 5 mg or 10 mg, or placebo for 12 weeks. ClinicalTrials.gov identifier: NCT01787188.

MAIN OUTCOME MEASURES:

The primary outcome measure was the mean change from baseline in WOMAC pain subscale score at week 12.

RESULTS:

Low-dose SoluMatrix meloxicam 5 mg (-36.52 [2.49]; P = 0.0005) and 10 mg (-34.41 [2.68]; P = 0.0059) once-daily treatment significantly reduced the mean (standard error) WOMAC pain subscale score from baseline at week 12 compared with placebo (-25.68 [2.64]). Patients treated with SoluMatrix meloxicam 5 mg or 10 mg reported significantly greater improvements in total WOMAC score and in WOMAC stiffness and function subscale scores at 12 weeks compared with placebo. The most common AEs in the combined low-dose SoluMatrix meloxicam group were headache, diarrhea, nausea, osteoarthritis, and urinary tract infection.

CONCLUSIONS:

Low-dose SoluMatrix meloxicam may have a potential role as a new therapeutic option for the management of OA-related pain.

KEYWORDS:

Chronic pain; Low-dose SoluMatrix meloxicam; NSAIDs; Osteoarthritis

PMID:
26503347
DOI:
10.1185/03007995.2015.1112772
[Indexed for MEDLINE]

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