Centaur Pharmaceuticals is readying to launch a New Chemical Entity (NCE) for treatment of diabetic foot ulcers, which the company expects will save patients from amputating their feet due to complications arising from the condition.

The Mumbai-based pharmaceutical major has collaborated with Germany’s CytoTools AG to develop the topical solution – branded as WOXheal – which will be available across the country by the end of the month. It will be available in Germany and other semi-regulated market in the next 6-12 months.

“This is first time such a product is being launched anywhere in the world. This helps in avoiding amputation by healing diabetic foot ulcers, an unmet medical need, and hence is a breakthrough innovation,” Centaur Pharmaceuticals Chairman and Managing Director SD Sawant told BusinessLine .

“CytoTools had discovered a molecule, which could be used for treatment of diabetic foot ulcers, while we provided the Active Pharmaceutical Ingredients (APIs),” he said, adding the companies were working on the product since 2005.

WOXheal contains the NCE, Diperoxochloric acid and has dual mechanism of action that has functional anti-bacterial action (against gram-positive and gram-negative bacterium) and also promotes growth of fibroblast cells. It helps in complete closure of the wound.

The company has received Indian Regulatory Authority approvals to manufacture and market the product in India, and the Drugs Controller General of India approval to market it. Centaur Pharma, which also markets anti-cold medicine Sinarest, had conducted its Phase II and III trials in India. It conducted randomised clinical trials across 15 centres in India and found that more than 90 per cent of the patients with non-healing diabetic foot ulcer showed reduction in the size of the ulcer. Nearly 75 per cent of them achieved complete healing within 6-8 weeks without any safety issue, he said.

The product comes in a pack (with total six packs required for complete treatment), which is for a week’s treatment, and includes gauzes, bandages, micro tapes and the topical solution.

Common complication

Amongst other complications of diabetes, diabetic foot ulcer is the most common complication seen in India.

Apart from the fact that diabetic foot ulcers are non-healing, they not only hamper the quality of life of the patient, but may also lead to complications such as wet gangrene, cellulitis, abscess and necrotising fasciitis all leading to a total or partial foot amputation.

About 25 per cent of people with diabetes will develop a diabetic foot ulcer in their lifetime, while one in five of the diabetics who are hospitalised due to severe foot infection, undergo a foot amputation.

The World Health Organization estimates 10 crore Indians to have diabetes in the next decade.

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