Iroko Pharmaceuticals Announces Acceptance of U.S. Filing for SoluMatrix® Meloxicam in Osteoarthritis Pain

FDA Approval Sought for Iroko’s Third SoluMatrix® NSAID

PHILADELPHIA, March 12, 2015 — Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, announced today that the U.S. 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,” said 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 management1.”

SoluMatrix® meloxicam was developed to align with recommendations from FDA and several professional medical organizations that NSAIDs be used at the lowest effective dose for the shortest possible duration consistent with individual patient treatment goals2. 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 U.S. 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 randomized 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 percent 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.

 

About Iroko Pharmaceuticals, LLC

Iroko is a global specialty pharmaceutical company, based in Philadelphia, dedicated to advancing the science of analgesia. The company develops and globally commercializes pharmaceutical products.

Iroko is at the forefront of the development of SoluMatrix® NSAIDs – new low dose drug products based on existing NSAIDs – using iCeutica Inc.’s proprietary SoluMatrix Fine Particle Technology™ exclusively licensed to Iroko for NSAIDs. The first SoluMatrix® NSAID is available in pharmacies and a second was approved by FDA. For more information, visit www.iroko.com.

 

Contacts:

Jessica Donnelly for Iroko Pharmaceuticals, LLC, 212-798-9819

Kate de Santis, Iroko Pharmaceuticals, LLC, 267-546-1682

 

SoluMatrix Fine Particle Technology™ is a trademark of iCeutica Inc., and the technology is licensed to Iroko for exclusive use in NSAIDs.

SoluMatrix® is a trademark of iCeutica Pty Ltd and is licensed to Iroko.

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1 Neogi T., et al. The epidemiology and impact of pain in osteoarthritis. Osteoarthritis Cartilage, 2013 http://www.ncbi.nlm.nih.gov/pubmed/23973124.

2U.S. Food and Drug Administration. Public Health Advisory – FDA Announces Important Changes and Additional Warnings for COX-2 Selective and Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).

3 IMS NPA Data, December 2014.

4 Altman, R., et al. Lower-Dose SoluMatrix® Meloxicam: Efficacy and Safety in a Phase 3 Study in Adults with Osteoarthritis Pain. Final Poster Presentation for 2014 European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology.