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

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 5mg and 10mg 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 40mm. Eligible patients experienced an OA pain flare (defined as a 15mm increase in the WOMAC pain subscale score) following discontinuation of NSAIDs/acetaminophen. Patients were randomized to receive once-daily SoluMatrix meloxicam 5mg or 10mg, 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 5mg (-36.52 [2.49]; P=0.0005) and 10mg (-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 5mg or 10mg 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.