Results of Phase 2 program to develop NSAIDs to be reported at ACR annual meeting

Nov 5 2011

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.

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.