New innovator

TopGel Wound healing solution

WOUNDS THAT won’t heal are a big problem for patients, their carers and the health service. Apart from the distress involved, chronic wounds are costly to keep treating as the success rate with dressings and existing pharmacological products is poor.

TopGel, a breakthrough wound healing gel jointly developed by the Royal College of Surgeons in Ireland (RCSI) and clinicians at Beaumont Hospital, looks set to change this and capture a slice of the multi-billion dollar worldwide market for wound care treatment.

TopGel is based on phenytoin sodium, a well-established anticonvulsant used to treat conditions such as epilepsy. Its ability to have a positive impact on wound healing was discovered inadvertently some time ago and is well documented. However, up to now no one has been able to get phenytoin into an easy-to-use format that would not irritate the skin on application.

“Numerous published studies support a positive role for topically-administered phenytoin in wound healing, but nobody had come up with a formulation with a suitable pH as free phenytoin is practically insoluble in aqueous vehicles,” says Prof John Kelly, outgoing director of research at the RCSI.

“This has been achieved with TopGel which improves healing time and reduces infection and can be produced at a fraction of the cost of competing products. It helps kick-start the healing process and is meant for short-term use with healing resistant wounds.”

The initial impetus to develop the gel came from consultant vascular surgeon, Prof David Bouchier-Hayes, and his team who collaborated with the RCSI’s School of Pharmacy to develop a useable formula for the product. This process took four years and cost in the region of €500,000.

The product has been successfully produced in commercially-viable volumes and its spinout from research to full commercialisation is being facilitated by the Technology Transfer Office at the RCSI.

“We are now looking for a partner for a full clinical trial,” says Kelly, who points out that, as TopGel has no direct competitors and is highly cost competitive to produce, it has the potential to succeed on a worldwide scale.

While TopGel works for both vascular and other types of wounds, there is a significant market opportunity within the field of diabetes. “The diabetic community worldwide is currently around 285 million people and with an estimated

seven million people developing diabetes each year this will bring the figure to 438 million by 2030. Unfortunately, approximately 15 per cent of diabetics can expect to get a non-healing ulcer in their lifetime,” says Kelly.