Mumbai- based pharma company, Centaur Pharmaceuticals to commence the post-marketing surveillance (PMS) study of its diabetic foot ulcer treatment drug WOXheal by end of January 2021.
In a recently held meeting, the Subject Expert Committee (SEC) recommended the grant of permission to conduct active post-marketing surveillance study of Centaur Pharma’ WOXheal diabetic drug. The committee also issued the following conditions for the PMS study.
1. The trial sites should be geographically distributed across the country.
2. More government sites should be included in the study.
3. Clinical trial investigators should be clinicians with post-graduation
qualification and surgeon should be Principal investigator/Co-principal investigator at each site.
4. Patients with HbA1c less than seven should be included.
5. Blood sugar level should be monitored at every visit and, at the last visit, HbA1c level should be checked.
6. The company should also conduct culture sensitivity for the study drug as well as concomitantly used other antibiotics.
Commenting on the given SEC recommendations, Dr Smita Phal, Director, Centaur Pharmaceuticals, said, “Postmarketing surveillance studies are conducted to generate safety data of the drug in the general population enrolling a large number of patients. In line with this, PMS study is planned for WOXheal after it was released in the market in October 2020, the protocol of which was submitted to CDSCO for approval. This protocol was deliberated in the expert committee meeting including CDSCO members and they have given permission to conduct the PMS study with minor recommendations in 200 to 500 patients with diabetic foot ulcer.”
Phal added, “Based on the SEC recommendations, we will be including three to four government sites. Besides this, other hospitals in all cities who have diabetic foot clinics or OPD will also be enrolled. We will strive to get as widespread across the country to cover all geographical areas.
The drug, a patented product, is effective in treating diabetic foot ulcers. It contains NCE, Diperoxochloric acid, which is also called DPOCL. It has a dual mechanism of action, i.e. functional antibacterial action against gram-positive and gram-negative bacteria. It also promotes the growth of fibroblast cells, thereby yielding complete wound closure, informed the company.