Xechem International has announced that its subsidiary, Xechem Pharmaceuticals Nigeria, has received approval from Nigeria's drug regulatory authority, the National Agency for Food and Drug Administration and Control, for the marketing and sale of Nicosan for the prophylactic management of sickle cell disease. The approval is for an initial term of two years, which will allow Xechem to complete confirmatory Phase III clinical trials in Nigeria. The company faces no restrictions on its ability to market and sell the drug in Nigeria.
Nicosan is an anti-sickling drug developed by Nigerian scientists at the National
Institute for Pharmaceutical Research and Development (NIPRD). In clinical studies conducted by NIPRD, the drug has shown to substantially reduce the degree of
sickling of the red blood cells of those afflicted with the disease. While not a cure, the clinical trials have confirmed that the large majority of patients
taking the drug no longer experience sickle cell "crises" while on the medication, and even among those whose crises are not eliminated, the number
and severity of the crises are substantially reduced.