Iroko Pharmaceuticals Gains FDA Approval of Zorvolex for Management of Osteoarthritis Pain

PHILADELPHIA, August 25, 2014 — Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, announced today the United States Food and Drug Administration (FDA) has approved Zorvolex (diclofenac) capsules, a nonsteroidal anti-inflammatory drug (NSAID), for the management of osteoarthritis pain. This marks the second indication for Zorvolex, approved by FDA in October 2013 for the treatment of mild to moderate acute pain in adults1.

“Given the dose-related adverse events associated with NSAIDs as a class and the widespread use of NSAIDs for osteoarthritis, we are delighted to gain approval for our first SoluMatrix® NSAID for the management of osteoarthritis pain,” said Dr. Clarence Young, Chief Medical Officer of Iroko Pharmaceuticals. “Iroko has already made great strides to help fill the need for low dose NSAID options in patients with acute pain and we are continuing to expand our portfolio to also address chronic pain indications.”

Zorvolex 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. Zorvolex is the first FDA-approved low dose NSAID developed using proprietary SoluMatrix Fine Particle Technology™ and is now available by prescription. Zorvolex contains diclofenac as submicron particles that are approximately 20 times smaller than their original size. The reduction in particle size provides an increased surface area, leading to faster dissolution.

“Expanding the use of Zorvolex beyond acute pain to osteoarthritis pain, a chronic condition, is a testament to Iroko’s continued commitment to developing a low dose NSAID portfolio to address a broad range of unmet patient needs,” said John Vavricka, President and CEO of Iroko Pharmaceuticals. “This second approval for Zorvolex continues to lay the groundwork for our future portfolio, which utilizes a new approach to pain management.”

The approval of Zorvolex for the management of osteoarthritis pain was supported by data from a 12-week, multi-center, randomized, double-blind, parallel-group, placebo-controlled trial that enrolled 305 patients, aged 41-90 years, with osteoarthritis of the hip or knee. Half of the patients were between the ages of 61-90. Participants were randomized to Zorvolex 35mg three times daily or 35mg twice daily, or placebo3. The Supplemental New Drug Application (sNDA) also included data from a 12-month open-label safety study that enrolled 602 patients1.

“NSAIDs continue to be an integral part of the management for osteoarthritis, the most common type of arthritis4, and their use is likely to increase as the U.S. population continues to age and the incidence of osteoarthritis rises5,” said Dr. Roy Altman, Professor of Medicine in Rheumatology at UCLA. “The approval of Zorvolex is a welcome and meaningful advance and is the first SoluMatrix® NSAID option approved by the FDA for osteoarthritis pain.”

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. Zorvolex is the first SoluMatrix® NSAID and is available in pharmacies; a second was approved by FDA in February 2014. For more information, visit www.iroko.com.

  1. ZORVOLEX Prescribing Information.
  2. U.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. Gibofsky, A., et al. Efficacy and safety of low-dose submicron diclofenac for the treatment of osteoarthritis pain: a 12 week, phase 3 study. Current Medical Research Opinion. 2014 Aug 6:1-11.
  4. The Burden of Musculoskeletal Diseases in the United States: Arthritis and Related Conditions. Chapter 4; 2011. http://www.boneandjointburden.org/pdfs/BMUS_chpt4_arthritis.pdf.
  5. Fine, Michael. Quantifying the Impact of NSAID-Associated Adverse Events. The American Journal of Managed Care, 2013. http://www.ajmc.com/publications/supplement/2013/A467_Nov13_NSAID/A467_Nov13_Fine_S267.

Posted: August 2014

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Zorvolex (diclofenac) FDA Approval History

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