Russia registered a unique drug for the treatment of proctological disorders

29 June 2018

GMP News

NovaMedica, a Russian pharmaceutical manufacturer and portfolio company of RUSNANO, has registered Fissario®, a unique drug for the treatment of proctological disorders based on a new mechanism of action not used in the products currently available on the market.

This is the first drug developed under NovaMedica’s own R&D program. According to the plans, it will become available to patients as early as in 2019.

“When developing Fissario®, our new drug, we used nanotechnology, thus, allowing to combine previously incompatible active substances in a gel and greatly improve their physical and chemical properties,” said Rustam Iksanov, Vice President for Pharmaceutical Operations at NovaMedica. “As a result, we obtained a new combination technological solution at the junction of two therapeutic areas, such as gastroenterology and pain management. I am sure that this approach and the proven high efficacy of the new drug will ensure its commercial success in the market, as it will be appreciated by both doctors and patients.”

During the multicenter randomized Phase III clinical studies, Fissario® confirmed its high efficacy and safety that had been demonstrated in the previous stages of drug study. It has also proven its superiority over the comparator drug which is one of the market leaders in this therapeutic area. Fissario® has also successfully passed pharmaceutical expert examination of quality in the Scientific Center for Expert Evaluation of Medicinal Products.

The novelty of Fissario® was confirmed by two Russian patents for inventions (No. 2606858 and No. 2641570) and two international patent applications. In the near future, two Eurasian patent applications will be also filed for this product.



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