The Russian pharmaceutical company NovaMedica has successfully completed the clinical trials of the first drug developed by its own R&D-division. The new drug is a gel for the treatment and alleviation of hemorrhoid symptoms. It is based on a unique mechanism of action that is not used in any existing drug in the market. The drug sales are planned to start at the end of 2017 under the trade name Fissario.
The drug has been developed using nanotechnology, which enabled the physicochemical characteristics of the active ingredients to be improved multiple times and allowed to combine the previously incompatible active substances in the form of an aqueous gel, providing both therapeutic and pain-relieving effects at the same time. New combinatory decisions have been used in development are the junction of two therapeutic areas: gastroenterology and pain management. The innovativeness of Fissario is supported by filing the four patents on invention applications including international applications, and for one of them a patent of the Russian Federation (No. 2606858) has been already granted.
During the multicenter randomized Phase III clinical studies, Fissario confirmed the data about its high efficacy and safety that were obtained in the early stages of the drug study. It also proved its superiority over the comparator drug, which is one of the market leaders in this therapeutic area.