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news.The US Food and Drug Administration (FDA) has accepted for review Iroko Pharmaceuticals' new drug application (NDA) for SoluMatrix meloxicam, a low dose nonsteroidal anti-inflammatory drug (NSAID), for the proposed indication of management of osteoarthritis pain.
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The NDA is based on data from a multi-center, double-blind and placebo-controlled Phase III trial of 402 patients, aged 40 and older, with osteoarthritis of the knee or hip.
During the trial, these patients were randomized to receive treatment with once-daily SoluMatrix meloxicam 5mg, SoluMatrix meloxicam 10mg, or placebo over a period of 12 weeks.
Results from the trial showed that both SoluMatrix meloxicam dosage strengths achieved efficacy at 33% lower doses than currently available meloxicam products.
The NDA also included data from a 12-month open-label trial that enrolled around 600 patients.
Iroko board executive chairman Osagie Imasogie said: "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.
"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 is the third low dose NSAID developed by the company using its SoluMatrix Fine Particle Technology and contains meloxicam as submicron particles that are about ten times smaller than their original size.
The company said that the reduction in particle size offers 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 last year.