FDA approves low dosage NSAID Vivlodex (meloxicam) for osteoarthritis pain- Iroko Pharma

The FDA has approved Vivlodex (meloxicam) capsules, from Iroko Pharma, for the management of osteoarthritis pain in 5 mg and 10 mg doses administered once daily. Vivlodex is the first FDA-approved low dose SoluMatrix meloxicam.

FDA approval of Vivlodex was supported by data from a Phase III multi-centre, double-blind, placebo-controlled study of 402 patients, aged 40 and older, with pain due to osteoarthritis of the knee or hip, who were randomised to receive treatment with once-daily Vivlodex 5 mg, Vivlodex 10 mg, or placebo over a period of 12 weeks. The Vivlodex doses studied achieved efficacy at 33% lower doses than currently available meloxicam products. The New Drug Application (NDA) also included data from a 12-month open-label safety study that enrolled 600 patients.

Comment: In 2014, the FDA approved Iroko Pharmaceutical's Tivorbex (indomethacin) at 20 and 40 mg doses for the treatment of mild to moderate acute pain in adults. Tivorbex was Iroko's second approved lower-dose NSAID. In October 2013, the FDA approved the company's Zorvolex (diclofenac) capsules for the treatment of mild to moderate acute pain in adults.