Petrovax Pharm received a positive Post Authorization Safety Study (PASS) report on injectable Polyoxidonium® 6 mg in the EU (Slovakia). The study confirmed the product’s high safety profile and favorable tolerability among patients.
The clinical study was initiated by the manufacturer in 2016 to update Polyoxidonium® general safety profile in clinical practice. The study was conducted in June – December 2016 to the applicable EU standards1, and was approved by the Ministry of Health of the Slovak Republic. Marketing Authorization ЕU PAS: ENCEPP/SDPP/12387.
The multicenter, prospective, open-label, non-interventional post authorization safety study (PASS) in routine medical practice involved 502 adults at 15 study sites, who were observed for a recommended treatment course. The product was assigned in patients with acute infections and chronic relapsing diseases of viral and bacterial origin. At the end of the study, the product general tolerability was assessed: 75.3% of the patients, and 79.7% of the investigators assessed tolerability as very high; 21.1% of the patients, and 19.3% of the investigators thought it was high. The manufacturer received an official positive study report: the safety profile was confirmed in all patient groups included in the study.
Post authorization safety studies (PASS) are a subgroup of postmarketing supervisory studies of frequency of the already known adverse events and the so-called “undetectable” rare adverse events. PASS also analyze potential risks of specific population categories as well as effectiveness of actions taken to minimize the previously discovered risks.
Polyoxidonium®, an innovative pharmaceutical product that combines immunomodulating, detoxifying, and anti-oxidative properties, has been used in Russia as well as the CIS and EU for more than 20 years. Over 10 years, it has been exported to Slovakia. This is an originator product developed by Russian scientists. The many-year experience of its application has proven its efficacy in treatment of multiple diseases in more than a dozen million patients. The product is used in acute and chronic infectious diseases of bacterial, viral, and fungal origin in pediatrics, general medicine, gynecology, urology, surgery as well as for influenza and ARVI prevention. In 2016, medical practitioners recognized Polyoxidonium® as the best immunomodulator for ARVI treatment in children; the product has become the Russian Pharma Awards winner.
1EU PAS Register Guide [EMA/613603/2012]; Guidance for the format and content of the final study report of non-interventional post-authorisation safety studies [EMA/48663/2013]; Guidance for the format and content of the protocol of non-interventional post-authorisation safety studies [EMA/623947/2012]; Guideline on good pharmacovigilance practice (GVP), Module VIII, Rev1 [EMA/813938/2011]