Pharmos arthritis cream is safe and effective

The trial evaluated 3% NanoEmulsion diclofenac topical cream. The analysis of the data indicates the formulation was safe with no serious adverse events. In addition, the pharmacokinetic analysis demonstrated low systemic exposure of diclofenac with no drug accumulation. These pharmacokinetic results in humans confirm the preclinical data previously obtained in animals showing reduced systemic plasma levels following topical administration of the NanoEmulsion cream.

“Based on strong market demand for safe and effective delivery vehicles for medications, and analgesics in particular, we feel our NanoEmulsion technology may offer new value and be a timely therapeutic alternative in the US and other major markets given current treatment voids and patient needs in this disease category,” said Alan Rubino president of Pharmos.

Topical application of drugs directly to pathological sites offers potential advantages over systemic delivery by producing high drug concentration in the affected tissue while avoiding unwanted side-effects. Many topical formulations employ chemical penetration enhancers to improve dermal penetration of drugs. Chemical enhancers may cause skin irritation and sensitization. An advantage of Pharmos’ NanoEmulsion is that it is composed of natural lipids and oils designed to minimize irritation.

The company’s NanoEmulsion containing diclofenac was also tested in a previous phase I human skin irritancy study where no irritation or allergic responses were observed after topical application.