Background: Amizon is a novel antiviral drug, designed by the Institute of Toxicology and Pharmacology under Ukraine Academy of Medical Science and licensed for medical use in Ukraine since 1996. It is solely manufactured by Farmak JSC (Kiev, Ukraine) in a dosage form of 250mg tablets.
In Russia, clinical trials to evaluate efficacy and safety of Amizon were officially authorized by the Federal Service «Roszdravnadzor» under Ministry of Health and Social Development of the Russian Federation in March 2009 (Permission # 112).
Clinical Study Summary: In 2009-2010 RII conducted clinical study of efficacy and safety of Amizon. The study involved 100 volunteers aged 18-60 and diagnosed with ARVI/Influenza, of which 43% of all cases were identified as influenza A monoinfections, 16% as adenovirus infections and 12% as influenza B infections. A number of patients had mixed infections combining influenza A or B viruses with adenoviruses. Unidentified ARI cases constituted 7%.
Among patients, 60 subjects received Amizon, 40 subjects — placebo. All subjects were prescribed with the necessary therapy, including pathogenetic and symptomatic treatment.
Results: The completed study showed high safety and tolerability of Amizon in test subjects. The use of Amizon in ARVI therapy shortened duration of main ARVI symptoms (intoxication, fever, catarrhal signs), and decreased overall severity of illness, shortened the duration of antigen presence in nasal washes, effectively eliminating the virus during therapy. The anti-inflammatory and interferongenic properties of Amizon shortened the manifestations of infectious process, and, in turn, acute phase of the illness, providing a faster patient recovery.
Based on the results Phase III investigations, safety and efficacy of Amizon to be included into influenza and ARVI therapy were demonstrated.
