Strains and sprains for Phosphagenics

Phosphagenics has begun a Phase 1 human clinical trial using its patented drug delivery system, TPM, for the targeted delivery of a leading non steroidal anti-inflammatory drug (NSAID), diclofenac.

The trial will compare the bioavailability and penetration of the topically applied Voltaren gel from Novartis, one of the leading marketed products for sprains, strains and arthritis pain, and Phosphagenics’ diclofenac.

Conducted at the Centre for Pharmaceutical Research at the University of South Australia, the principal investigator is Professor Allan Evans. The trial is an open label, single centre bioavailability and penetration trial of dermal and systemic pharmacokinetics in 12 healthy adult volunteers, incorporating secondary endpoints of safety and tolerability.

The company expects to obtain and announce the results of this phase 1 trial in the first quarter of 2009.

Phosphagenics’ executive vice president of research and development, Dr Esra Ogru, said the company’s formulation increased the amount of drug delivered to the site of action.