Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, announced that the US Food and Drug Administration (FDA) accepted for review the New Drug Application (NDA) for SoluMatrix meloxicam, a low dose nonsteroidal anti-inflammatory drug (NSAID), for the proposed indication of management of osteoarthritis pain.
“We are pleased to reach this important milestone, which marks the third product in Iroko’s portfolio of NSAIDs developed using the proprietary SoluMatrix Fine Particle Technology for which we have sought FDA approval,” says Osagie Imasogie, executive chairman of the Iroko Board. “Iroko is one step closer to bringing another potential non-opioid treatment option to the 27 million Americans living with osteoarthritis who may require long-term pain management.”
SoluMatrix meloxicam was developed to align with recommendations from FDA and several professional medical organisations that NSAIDs be used at the lowest effective dose for the shortest possible duration consistent with individual patient treatment goals. SoluMatrix meloxicam is the third low dose NSAID developed by Iroko using proprietary SoluMatrix Fine Particle Technology and contains meloxicam as submicron particles that are approximately 10 times smaller than their original size. The reduction in particle size provides an increased surface area, leading to faster dissolution. Meloxicam is the second largest prescription NSAID used in the US with over 26 million prescriptions written in 20143.
The NDA submission for SoluMatrix meloxicam included data from a Phase 3, multi-center, double-blind and placebo-controlled study, of 402 patients, aged 40 and older, with osteoarthritis of the knee or hip who were randomised to receive treatment with once-daily SoluMatrix meloxicam 5 mg, SoluMatrix meloxicam 10 mg, or placebo over a period of 12 weeks. Data from this study showed that both SoluMatrix meloxicam dosage strengths achieved efficacy at 33 per cent lower doses than currently available meloxicam products. These data were presented at the 2014 European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology in Paris, France4. The NDA also included data from a 12-month open-label study that enrolled 600 patients.