EFFECTIVENESS AND TOLERANCE OF ENISAMIUM IODIDE NASAL SPRAY: PRE-CLINICAL STUDY AND CLINICAL TRIAL RESULTS
DOI:
https://doi.org/10.11603/mcch.2410-681X.2020.v.i1.11059Keywords:
experimental rhinosinusitis, Enisamium Iodide (nasal spray), portability, safetyAbstract
Introduction. There are differences in acute rhinosinusitis (ARS) treatment approaches depending on the leading clinical symptoms, in particular, nasal obstruction and facial pain. Farmak JSC (Ukraine) has developed a new nasal spray with Enisamium Iodide (EI) aqueous solution – original dosage form of a well-known pharmaceutical substance.
The aim of the study – to substantiate the effectiveness of EI (nasal spray) in the treatment of certain pathology and tolerance/safety of its use.
Researsch Methods. EI (nasal spray) 10 mg/mL was the study subject. BNO-101 under the trade name Sinupret® was used as a reference drug in the experimental part of the study. Experimental rhinosinusitis (ERS) was induced in 24 rabbits (4 groups, 6 rabbits in each group) on the first experimental day. Since 15th day, the animals received the drugs for 10 days: 0.9 % saline at 0.1 ml intranasally in the intact control and control pathology group, EI (nasal spray) at 0.1 ml intranasally in the 3rd group and BNO-101 at 25 mg/mL intragastrally in the 4th group. Treatment results were evaluated on the 25th day (laboratory observation, peripheral blood analysis results). The clinical part of the work has been conducted as a single-centre, randomized, double-blinded, placebo-controlled clinical trial with dose escalation – study of local tolerance and safety (Phase I) of different doses of the new drug EI (nasal spray) 10 mg/mL with healthy volunteers.
Results and Discussion. The results indicate that EI (nasal spray) is able to positively influence on ERS significantly due to local action. Statistical data analysis of local tolerance indicates that EI is not inferior to placebo in indicators of “local tolerance” and “safety”, and all differences are statistically insignificant.
Conclusions. The preclinical study results indicate that Enisamium iodide under the laboratory observations and hematological analyzes has a positive effect on ERS, and in activity is not inferior to BNO-101 as comparison drug. Statistical data analysis of clinical trial indicates good tolerance/safety of Enisamium Iodide (nasal spray) 10 mg/mL.
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