Nobazit® - new indications for use

04.04.2023

On March 28, 2023, within the framework of the XV Annual All-Russian Congress on Infectious Diseases named after the Academician V.I. Pokrovsky, a symposium was held on the viral diseases treatment current issues, entitled “Universal Approaches to the Therapy of Respiratory Viral Infections during the COVID-19 Pandemic.”

Leading experts in the field of viral infection therapy took the floor at the symposium, including:

•          N.Yu. Pshenichnaya, Professor, holder of Post-Doctoral Degree in Medicine, Deputy Director for Clinical and Analytical Work, Federal Budget Science Institution "Central Research Institute of Epidemiology" of the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing (Rospotrebnadzor)

•          D.A. Lioznov, Professor, holder of Post-Doctoral Degree in Medicine, Director of the A.A. Smorodintsev Influenza Research Institute.

•          V.K. Zhdanov, Professor, holder of Post-Doctoral Degree in Medicine, Chief Infectious Disease Specialist of the Ministry of Health of the Russian Federation, Corresponding Member of the Russian Academy of Sciences.

During the symposium, experts confirmed that despite the Omicron strain decreasing activity, coronavirus remains a relevant infection. According to the World Health Organization (WHO), over the past 28 days, 4.1 million new cases of the disease have been registered. However, the presented data may not fully characterize the real situation, as there is a sharp reduction in the number of COVID-19 tests and a delay in receiving epidemiological reports from individual countries, which does not allow the WHO to declare the pandemic over¹. The situation remains tense in the Russian Federation.

“Today, in Russia, more than 150,000 patients with a confirmed diagnosis of COVID 19 are under observation”, noted V.K. Zhdanov.

The main news of the symposium was the results of an adaptive, randomized, open, controlled phase III study to evaluate the efficacy and safety of Nobazit®, film-coated tablets, 250 mg (“Avexima”, OJSC, Russia) in the treatment of hospitalized patients with an infection caused by the SARS-CoV-2 virus (COVID-19), conducted in 10 clinical centers in the Russian Federation.

In the conducted clinical trial, the use of Nobazit® in addition to standard therapy in adult patients with COVID-19 contributed to a faster and more sustained resolution of the main symptoms of COVID-19 (fever, tachypnea, and decreased blood oxygen saturation).

According to the clinical trial protocol approved by the Ministry of Health of the Russian Federation, the effectiveness of Nobazit®, film-coated tablets, 250mg, in the therapy of COVID-19 is considered proven.

Based on the results obtained and in accordance with the decision of the Ministry of Health of the Russian Federation dated March 23, 2023, No. 25-6-4231554/ID/IZM, the instructions for medical use of the drug Nobazit®, film-coated tablets, 250mg, have been supplemented with the following indication:

“Treatment of a novel coronavirus infection (COVID-19), confirmed by the results of a diagnostic test for SARS-CoV-2, of moderate course, in adults who do not require additional oxygen therapy, as part of complex therapy”.

The full results of the study are now available to healthcare professionals in the first issue of the Journal of Infectious Diseases 2023².

Dmitry Anatolyevich Lioznov, the Director of the A.A. Smorodintsev Influenza Research Institute, presented the universal approaches to the acute respiratory viral infections (ARVI) and influenza therapy during the COVID-19 pandemic in his report.

“Despite the decline in coronavirus incidence, new challenges and peaks of seasonal viral infections are ahead of us. "Nobazit" is a drug that has proven its ability to directly act on various types of viruses and has a complex effect, significantly reducing both local and systemic (intoxication) symptoms of influenza and ARVI, while significantly reducing the duration of the disease. And the most important thing is that it is a Russian drug that is included in the clinical recommendations of the Ministry of Health of the Russian Federation for the influenza⁴ and ARVI⁵ treatment in adults,” D.A. Lioznov noted.

Natalya Yurievna Pshenichnaya noted the inflammation leading role in the respiratory tract infections pathogenesis. In the uncontrolled inflammatory reactions onset, known as the “cytokine storm,” one of the leading roles is played by a delicate balance between the pro-inflammatory cytokines IL-1, IL-6 and the main anti-inflammatory cytokine IL-10 levels. The relevance of monitoring these cytokines levels is associated with the fact that such pathologies can be observed not only with COVID-19, but also with a number of other respiratory infections, including seasonal influenza.

The results of a study conducted at the Pirogov Russian National Research Medical University³ were also discussed in detail during the report, which proved the peculiarity of the Enisamium Iodide molecule (the active substance of the drug Nobazit®) in reducing the level of expression of genes for pro-inflammatory cytokines IL-1, IL-6 and increasing the level of anti-inflammatory cytokines IL-10, thus preventing the hyperinflammatory response developing risk.

N.Yu. Pshenichnaya stated that based on the overall data obtained, the drug Nobazit® (international non-proprietory name (INN) - Enisamium Iodide) may be a drug of choice in the acute respiratory viral infections (ARVI) treatment, including those occurring with the immune system hyperergic reaction.

1.       https://www.who.int/publications/m/item/weekly-epidemiological-update-on-covid-19---16-march-2023

2.       N.Yu. Pshenichnaya, V.K. Zhdanov, D.A. Lioznov. Final Results of an Adaptive Randomized Open-Label Controlled Study of the Effectiveness and Safety of Enisamium Iodide in the Treatment of Hospitalized Patients with COVID-19. Infectious Diseases Journal, 2023; Vol. 21, No. 1, pp. 17-24

3.       The Clinical Guidelines of the Ministry of Health of the Russian Federation “Acute respiratory infections (ARVI) in adults”, 2021.

4.       The Clinical Guidelines of the Ministry of Health of the Russian Federation “Influenza in adults”, 2022.

5.       Kareva E.N., Fedotcheva T.A., Semeykin A.V., Kochina N.A., Krasnoschok E.V., Shimanovsky N.L. Enisamium iodide – the effect on key components of the inflammatory process in ARVI. Therapeutic Archive, 2022;94(11):1262–1267