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The results of the Phase 2 program sponsored by Iroko Pharmaceuticals to develop novel, lower-dose formulations of a widely used class of pain medicines will be reported November 7th at the annual meeting of the American College of Rheumatology (ACR) in Chicago.
The data result from a broad development effort using a proprietary nanotechnology to re-formulate certain products in the large class of pain medicines called NSAIDs (non-steroidal anti-inflammatory drugs). Nano-formulations reduce drug particle size and enhance drug dissolution in the body.
The objective is to lower the dosing of NSAIDs and thus improve their safety and tolerability while maintaining their effectiveness. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) both have advised that NSAIDs should be administered at the lowest effective dose for the shortest duration consistent with treatment goals.1,2
Iroko has initiated its Phase 3 program.
At the ACR meeting, the Phase 2 results will be the subject of three presentations:
Application of Nanotechnology to Improve Non-Steroidal Anti-Inflammatory Drugs
(Presentation Number: 1282)
A Phase 2 Study Evaluating the Acute Pain Relief of a Nano-Formulated Oral Naproxen
(Presentation Number: 1281)
Acute Pain Relief by a Proprietary, Nano-Formulated Lower-Dose Oral Indomethacin
(Presentation Number: 1280)
The presentations will be made on November 7th from 9:00-11:00 AM in the F2 Poster Hall at the McCormick Place Convention Center.
Iroko formulates NSAIDs using the proprietary SoluMatrix™ nanotechnology platform of its partner, iCeutica. These product candidates are intended for administration at lower doses without compromising onset of action and effectiveness, in keeping with the public-health advisories of the FDA and the EMA.
About Iroko Pharmaceuticals, LLC
Iroko is a pharmaceutical company focused on specialty therapeutic areas. The company acquires, develops and maximizes the potential of currently marketed products on a global basis through focused selling and marketing efforts and product-life-cycle management activities including development of new formulations to improve patient treatment.
1Public Health Advisory – FDA Announces Important Changes and Additional Warnings for COX-2 Selective and Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDS). July 7, 2005.
2Opinion of the Committee for Medicinal Products for Human Use Pursuant to Article 5(3) of Regulation (EC) No 726/2004, for Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDS). October 18, 2006.
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