PHARMOS COMPLETES STUDY OF TOPICAL NSAID CREAM

Pharmos announced it has completed its initial analysis of data from a recently completed Phase 1 study of its proprietary NanoEmulsion topical drug-delivery technology formulated with diclofenac. Diclofenac is an approved and widely used non-steroidal anti-inflammatory drug (NSAID). The analysis of the data indicates the formulation was safe and well-tolerated with no severe or serious adverse events; subject compliance with the 14-day treatment period was excellent, according to the company. In addition, the pharmacokinetic analysis demonstrated low systemic exposure of diclofenac with no drug accumulation following repeated daily administrations. These results in humans confirm the preclinical data showing reduced systemic plasma levels following topical administration of the NanoEmulsion cream.

The single-center, open-label, multiple-dose, topical-application study included 16 healthy male and female volunteers. The trial evaluated the safety, tolerability and pharmacokinetic profile of 3 percent NanoEmulsion diclofenac topical cream following 14 days of three daily administrations.

Pharmos is developing the NanoEmulsion topical diclofenac cream as a potential treatment for osteoarthritis pain. It is estimated that 20 percent of osteoarthritis patients are not receiving treatment, mainly due to gastrointestinal side effects of oral NSAIDs and cardiovascular risk of COX-2 inhibitors, according to Pharmos. A topical NSAID offering adequate pain relief targeted to the site of injury with an improved safety profile could become a treatment alternative for these patients. Topical diclofenac is also being considered as treatment for soft tissue injuries, sprains and strains.

Pharmos' NanoEmulsion technology consists of an efficient solvent-free topical vehicle based on drug entrapment in stable, submicron particles of oil-in-water emulsions with a mean droplet size between 100 and 200 nanometers that are uniformly dispersed in an aqueous phase.