Polyoxidonium® approved for new applications, now in children aged 3+ years

Petrovax Pharm reports on Polyoxidonium^® tablets 12 mg age scope extension. This product was approved for children aged 3+ years. The PIL change was approved by the Russian Ministry of Health.^[1]

Polyoxidonium^® tablets 12 mg age scope extension was registered on the back of clinical study data that confirmed the product’s high efficacy in combined treatment of acute respiratory infections (ARI) as well as its high safety profile.^[2]

Clinical studies involved 228 subjects aged 3 to 14 years diagnosed with ARI of the upper respiratory tract or influenza from 7 clinical centers in Russia with relevant experience of ARI treatment in children. The studies were conducted as prospective, multicenter, double-blind, placebo-controlled, comparative, randomized, parallel-arm clinical trials in compliance with the GCP regulations.

Prof. Susanna Kharit, MD, Chief Independent Expert for Immunization of Children, St. Petersburg Health Committee, noted that “the data obtained from two clinical trials demonstrated that Polyoxidonium^® application as a combined ARI therapy normalized the body temperature and provided for a positive ARI and flu treatment dynamics in a shorter time, as well as decreased the ARI relapse rate twofold based on a 6-month follow-up after the treatment completion. Polyoxidonium^® clinical efficacy and safety, its immunomodulating and anti-inflammatory properties support recommendations for the product inclusion into the range of medications used for ARI treatment in children aged 3+ years”.

Polyoxidonium^®: background information

Polyoxidonium® (azoximer bromide) is an originator Russian product with immunomodulating, detoxifying, and anti-oxidative properties. Due to its unique formula, the medication is used for combined treatment of acute and chronic respiratory infections of bacterial, viral, or fungal origin as well as for influenza and ARVI prevention both in children and adults.

In 2016, Polyoxidonium® was recognized as the best immunomodulator to treat ARVI in children, and won the Russian Pharma Awards.^[3]

The product has a complex of properties essential for a child in an acute respiratory infection phase, i.e. it removes intoxication and inflammation, and activates interferon production. Symptoms and general state improvement is observed in the first days of treatment.^[4] Polyoxidonium^® restores immune defense in sickly children, and enhances the child’s body resistance. The clinical application experience in ARVI acute phase showed a decrease of the risk of bacterial complications and ARI within a year following a treatment course.^[5]

Polyoxidonium^® is manufactured at a state-of-the-art facility to international GMP standards, which guarantees its high quality. The product is exported to the CIS and EU.

           

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^[1] Patient Information Leaflet for Polyoxidonuim ®, tablets 12 mg, R No. 002935/04-010617, approved by the Russian Ministry of Health on 01.06.2017.

^[2] С.М. Харит, А.Н. Галустян «Азоксимера бромид – безопасный и эффективный препарат при лечении острых респираторных инфекций верхних дыхательных путей у детей: обзор результатов двойных слепых плацебо-контролируемых рандомизированных клинических исследований II-III фазы.

^[3] http://awards.doktornarabote.ru/pobediteli2016

^[4]Вавилова В.П., Вавилов А.М., Черкаева А.Х. Возможности современной терапии острых респираторных вирусных инфекций у детей. Consilium Medicum. Педиатрия 2015, №3

^[5] Харламова Ф.С., Учайкин В.Ф., Кузьменко Л.В., Чирун Н.В. и др. Опыт применения иммуномодулятора Полиоксидоний для лечения ОРИ у детей. Эффективная фармакотерапия, 11/2013.