NPO Petrovax Pharm received a report on successful Post Authorization Safety Study (PASS) of Polyoxidonium® 6 mg injection in the European Union (Slovakia). The study confirmed high safety profile of the drug and its good tolerability, reported the press service of the company.
The company initiated the clinical study in 2016 in order to update the general safety profile of Polyoxidonium® in clinical practice. The study was conducted in June – December 2016 in accordance with the European standards and was approved by the Ministry of Health of the Slovak Republic. EU PAS register number is ENCEPP/SDPP/12387
The multi-center, prospective, open, non-interventional Post Authorization Safety Study (PASS) in a standard medical practice involved 502 adult patients observed during the recommended course of therapy in 15 research centers. The drug was used in patients with acute infections and chronic recurrent viral and bacterial infections. At the end of the study the assessment of general tolerability of the medicine was performed. 75.3% of patients and 79.7% of investigators assessed the tolerability as very good; 21.1% of patients and 19.3% of investigators, as good. The company received an official report on successful results of the study. The safety profile was confirmed for all categories of patients included in the study.