Iroko Pharmaceuticals Comments on Joint FDA Advisory Committee Meeting on NSAIDs

PHILADELPHIA, FEBRUARY 12, 2014 — On February 10 and 11, 2014, the U.S. Food and Drug Administration (FDA) Joint Meeting of the Arthritis Advisory Committee (AAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM) discussed data and analyses published post 2005 that are relevant to further understanding the relationship between nonsteroidal anti-inflammatory drugs (NSAIDs) and cardiovascular thrombotic risk that is currently described in NSAID class labeling. Iroko addressed the panel as the second industry presenter. Presentations were also made by Pfizer, Novartis, Bayer and McNeil Consumer Health.

“We were pleased to have been invited to participate in this joint advisory committee meeting to review new safety data regarding the use of NSAIDs,“ said John Vavricka, Iroko President and CEO. “Our participation was a reflection of our continued commitment to fostering progress within the NSAID class and we are appreciative that a member of this distinguished panel recognized Iroko’s contribution to developing innovative lower dose options for patients and physicians.”

At the meeting, Iroko Chief Medical Officer Dr. Clarence Young presented on the impact of pain in patients with osteoarthritis, as well as new data regarding the cardiovascular risks associated with currently available NSAIDs and highlighted the Company’s efforts to provide lower dose options that are safe and effective.

“We are encouraged by the attention given to the relationship between NSAIDs and the risk of serious adverse events, specifically regarding the absence of a cardiovascular risk latency period which has important implications for NSAID use in both acute and chronic pain,” said Dr. Young. “Iroko is committed to the development of a portfolio of six NSAIDs using the SoluMatrix Fine Particle Technology™.  Our first product was approved by FDA in October 2013 and is a step forward in providing physicians and patients with another treatment option, as no one NSAID is appropriate for all 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. In addition to the Iroko products that are marketed worldwide, the company has a robust pipeline of investigational lower dose NSAID products being developed using iCeutica Inc.’s proprietary SoluMatrix Fine Particle Technology™. For more information, visit


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 is licensed to Iroko for exclusive use in NSAIDs.