Pharmos (PARS) Announces Phase 2a Trial of NanoEmulsion Did Not Achieve Statistical Significance

November 19, 2008 5:38 PM EST

Pharmos Corporation (Nasdaq: PARS) today announced results from its Phase 2a clinical trial of its topical NanoEmulsion drug delivery technology formulated with 3% Diclofenac Diethanolamine.

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 NSAID (non-steroidal anti-inflammatory drug) products already approved or currently in development in the US.

This study confirmed the safety of the 3% NanoEmulsion Diclofenac Diethanolamine cream previously demonstrated in the Phase I study. The majority of the reported adverse events were defined as mild in severity and most of them were regarded by the investigators as not drug related. No Serious AE's were reported and the effect of the NanoEmulsion cream on the skin was minimal.

Pharmos has decided to discontinue its topical NanoEmulsion drug delivery program.

Pharmos Corporation, a biopharmaceutical company, together with its subsidiaries, engages in the discovery and development of novel therapeutic drugs to treat a range of diseases of the nervous system, including disorders of the brain-gut axis, such as irritable bowel syndrome (IBS) in the United States and Israel.

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