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Pharmos initiates clinical program for treatment of pain

New Jersey-based drug maker Pharmos has launched a new clinical program that it says will evaluate the effects of a non-steroidal anti-inflammatory drug formulated in its tissue-directed drug delivery technology, NanoEmulsion, in patients with osteoarthritic pain in the knee.

According to the company, NanoEmulsion acts as a vehicle for lipophilic drugs directly to the tissue. Preclinical data has revealed positive effects of the technology when applied to animal models.

Pharmos claims topical application of drugs directly to pathological sites produces high drug concentration in the affected tissue while avoiding unwanted side-effects due to high systemic drug levels.

Topical preparations of non-steroidal anti-inflammatory drugs (NSAIDs) are commonly used as painkillers and anti-inflammatory agents to treat various disorders such as arthropathies and myalgias. Some employ chemical penetration enhancers to improve dermal penetration of drugs, which can cause skin irritation and sensitization. NanoEmulsion is designed to minimize irritation through natural lipids and oils.

Pharmos conducted a phase I trial that tested its NanoEmulsion containing diclofenac in human skin irritancy. The results showed no irritation or allergic responses after topical application.

NanoEmulsion technology consists of a solvent-free topical vehicle based on drug entrapment in particles of oil-in-water emulsions.