06 September 2006
New topical analgesics formulation beats leading brands in human skin studies
Futura Medical plc (AIM: FUM) the pharmaceutical and medical device group, today announces that its new topical non-steroidal anti-inflammatory (NSAID) formulation, known as DCF100, has shown impressive results in recently conducted in vitro human skin permeation studies with permeation rates in excess of eight times higher than the world’s current market leader.
Permeation through human abdominal skin was measured in a validated model for a variety of formulations in studies conducted by Professor Mike Roberts at the University of Queensland in Australia. Professor Roberts is a world-renowned expert in skin permeability of pharmaceutical compounds.
The dramatic improvement in permeation rates observed in DCF100 formulations compared with two over the counter topical brands, including the world’s market leader, Voltarol® Emulgel, is highlighted in a graph viewable at http://www.futuramedical.co.uk/archive/060906_graph.pdf DCF100 also showed a statistically significant improvement in drug delivered through the skin in a 24 hour period from a single dose compared with Pennsaid®, a prescription based topical NSAID which up until now has provided the best reported permeation rates for topical Diclofenac.
Voltarol® Emulgel worldwide topical sales are estimated to be US$215 million out of a current worldwide market for topical NSAIDs in 2005 of US$2.35 billion. No topical NSAID has yet received marketing authorisation within the USA from the Food and Drug Administration (FDA). This is due to concerns that NSAIDs cannot permeate the skin in sufficient quantity to deliver a therapeutic dose. This may however change with the regulatory dossier on Pennsaid® recently being submitted to the FDA to obtain marketing authorisation due to its improved skin permeation compared with existing topical NSAIDs. We expect the market for topical NSAIDs to grow significantly once the FDA approves products.
Plans are at an advanced stage to conduct human tissue micro-dialysis and plasma level studies later this year with Futura’s preferred DCF100 formulation. These studies aim to confirm local targeted delivery, thereby demonstrating the potential for excellent clinical efficacy but without systemic uptake and the associated side effects often associated with oral NSAIDs. In the meantime discussions are underway with potential distributors for DCF100, the outcome of which will be announced to shareholders in due course.
Professor Mike Roberts said: “Topical formulations have sought to deliver an effective therapeutic dose of Diclofenac from a safe and user friendly topically applied formulation. Initial in vitro studies suggest Futura's DCF100 formulations deliver high effective doses of Diclofenac and are supportive of their further clinical development for topical NSAIDs.”
James Barder, Chief Executive of Futura, said: “These results beat our own internal expectations and we see a significant opportunity to develop a further valuable asset for our shareholders at limited cost and risk. These studies also support our belief that our delivery system, initially developed for MED2002, has significant commercial applications beyond MED2002.”