Small-Particle Meloxicam Shows Promise in Treatment of OA Pain
Low-dose therapy evaluated in phase III trial
In a new phase III study, patients with osteoarthritis (OA) treated with investigational SoluMatrix meloxicam (Iroko Pharmaceuticals), a low-dose nonsteroidal anti-inflammatory drug (NSAID), reported significantly greater pain relief compared with patients given placebo.
The findings were presented at the 2014 European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology in Paris, France.
In the double-blind, placebo-controlled trial, 403 patients aged 40 years and older with a clinical diagnosis of OA of the knee or hip were randomly assigned to receive once-daily SoluMatrix meloxicam 5 mg, SoluMatrix meloxicam 10 mg, or placebo.
The study’s primary efficacy endpoint was the mean change from baseline in the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index pain subscale score at week 12. Secondary efficacy endpoints included the Patient Global Impression of Change (PGIC), a patient-reported outcome measure, as well as the amount of rescue medication (acetaminophen) used by each patient.
At week 12, patients treated with SoluMatrix meloxicam 5 mg (P = 0.0005) and 10 mg (P = 0.0059) achieved significantly greater pain relief, as measured by the WOMAC pain subscale score, compared with patients receiving placebo. Moreover, based on the PGIC, significantly more patients reported their condition as “very much improved” or “much improved” versus “much worse” or “very much worse” after treatment with SoluMatrix meloxicam 5 mg (P = 0.0049) or 10 mg (P = 0.0012) compared with those given placebo.
Patients in the SoluMatrix meloxicam 5-mg (P = 0.006) and 10-mg (P = 0.0013) treatment groups used significantly less rescue medication compared with patients in the placebo group.
The most frequently reported adverse events in patients treated with SoluMatrix meloxicam were diarrhea, headache, and nausea.
SoluMatrix Fine Particle Technology (iCeutica Inc.) produces NSAIDs as submicron particles that are approximately 20 times smaller than their original size. This reduction in particle size provides an increased surface area, leading to faster dissolution.
Source: Iroko Pharmaceuticals; June 12, 2014.