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news.Phosphagenics, a biotechnology company, has initiated a Phase I human clinical trial using its patented drug delivery system, TPM, for the targeted delivery of a non steroidal anti-inflammatory drug, diclofenac.
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The trial will compare the bioavailability and penetration of the topically applied Voltaren gel (1% diclofenac) and Phosphagenics’s diclofenac (at 1% and 2% diclofenac concentrations).
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 I trial in the first quarter of 2009.
Esra Ogru, executive vice president of R&D at Phosphagenics, said: “The advantage of our formulated diclofenac is that it increases the amount of anti-inflammatory drug delivered to the site of action. Sales of Voltaren in 2007 for both oral and topical application were around $700 million, so we are very pleased to be entering into the clinic with our new formulation as we believe its superior efficacy will prove it to be a very attractive product commercially.”