The multi-center, randomized, double-blinded, placebo-controlled study evaluated the safety and efficacy of the company’s 3% diclofenac diethanolamine NanoEmulsion cream in 104 patients with chronic pain due to osteoarthritis of the knee. Patients applied the topical cream three times daily for 28 days.
The study did not achieve statistical significance in its primary efficacy endpoint, nor in several secondary endpoints. The effect witnessed did not measure up to other topical non-steroidal anti-inflammatory drug (NSAID) products already approved or currently in development in the US.
Pharmos has decided to discontinue its topical NanoEmulsion drug delivery program. The company’s operations in Israel were closed effective October 31, 2008, and the company is seeking to license/partner its only remaining program – the CB2 Selective Agonist program targeting pain and inflammation. No further development work is being conducted on that program.
The company is focusing all its resources on its dextofisopam clinical trial for irritable bowel syndrome currently enrolling in a 480 patient Phase IIb trial.