THD NewsDesk, Mumbai : Centaur Pharmaceuticals is starting a diabetic foot ulcer remedy drug Woxheal. It is a New Chemical Entity (NCE) in the country. The medicine will be accessible from October 1, 2020, across the country. The price of the drug will be Rs 1850 for a week’s treatment.
The corporation will be producing the medicines from its agencies established in Mumbai and Goa and the active pharmaceutical ingredients (APIs) from its site settled in Pune. All the three agencies are US FDA approved.
S. D. Sawant, Chairman and MD, Centaur Pharmaceuticals said, “It is a unique product for the treatment of diabetic foot ulcers, and we are sure that it will save millions of diabetics who have to undergo foot amputation globally. This is a result of intense research work which have been carried in the last 14 years for developing this novel drug.”
He further said, “We, at Centaur Pharmaceuticals, are deeply concerned with the alarming rate of foot amputations in India, and wanted to discover a drug to prevent it. Nearly 15 years ago, we collaborated with CytoTools AG, Germany, who had this promising molecule for the treatment of diabetic foot ulcer. We are very happy to offer this ray of hope to people with a diabetic foot ulcer in India.”
As per Dr Dirk Kaiser, the co-innovator of WOXheal and the Chief Scientific Officer of CytoTools AG added, “WOXheal is a topical solution that will change the way diabetic foot ulcer management is done and will help prevent amputation. It is a novel drug born out of Indo-German collaboration and is shown to be very effective in treating diabetic foot ulcer.”
Dr Kaiser continued that phase III clinical trials for the drug were continuing in Europe though the outcomes from phase II clinical trials were similar to Indian clinical trials.
Dr Mark-Andre Freyberg, the co-innovator of WOXheal and CEO of CytoTools AG, Germany said, “Woxheal has completed Phase III clinical trials in India and demonstrated rapid and effective wound healing in patients with diabetic foot ulcers, a condition that is notoriously difficult to treat.”
According to the data presented by the company, it is a universally patented product and contains the NCE, Diperoxochloric acid (DPOCL). It has a twofold procedure, which shows antibacterial action against gram-positive and gram-negative bacteria. It also supports the growth of fibroblast cells, hence allowing total wound cessation.
To assess the potency and safety of wound healing solution. A clinical trial was conducted to examine DPOCL in patients with a diabetic foot ulcer, for a multicentric, randomised, double-blind, double-arm, active-controlled, comparative, parallel-group. A total of 289 patients have registered out of which 139 patients were from the WOXheal arm examination while 150 from Active-control 0.9 per cent saline arm. The outcomes showed that 105 of 139 patients [75.54 per cent] patients from test WOXheal arm had achieved wound cessation. Whereas, 93 of 150 patients [62 per cent] from Active-control 0.9 per cent saline arm had achieved wound cessation.
The examination summarises that the test WOXheal arm displayed speedy wound cessation as it took 42 days. Though with Active-control 0.9 per cent saline arm the wound cessation took 56 days.
Through the arbitrary clinical trials organised over India in more than 15 clinical trial centres. The company notified that over 90 per cent patients with non-healing diabetic foot ulcer showed a contraction in the size of the ulcer, and 75 per cent out of these patients achieved total healing within six to eight weeks without any safety issue.
The company has production and marketing permission from the DCGI for the drug in 2019. It has planned to export the drug worldwide. This drug will be a boon for the patients suffering from a disease which could lead to amputation.