The use of fenspiride for the combined treatment of exacerbation of chronic laryngitis

Abstract

The present study was carried out based at the Department of Otorhinolaryngology of I.P. Pavlov First State Medical University of Saint-Petersburg. The objective of this work was to elucidate the efficacy and safety of fenspiride therapy for the treatment of exacerbation of chronic laryngitis associated with an acute respiratory infection. The patients comprising the main group received fenspiride (Eurespal, 'Servier', France) at the standard dose in addition to the conventional therapy with the use of antibiotics, inhalation, and voice rest. The patients in the group of comparison were treated following the conventional protocol without fenspiride. The clinical symptoms evaluated based on the scoring system, the results of videolaryngoscopy, and computer-assisted analysis of the voice were compared before and after treatment in the patients of both groups. The results of the study have confirmed the high effectiveness and safety of fenspiride therapy of exacerbation of chronic laryngitis.

Utilization of mechanistic modelling and simulation to analyse fenspiride proarrhythmic potency – Role of physiological and other non‐drug related parameters

“…Fenspiride has multiple potential clinical endpoints including relaxation of tracheobronchial musculature, anti‐inflammatory activity, and antihistamine activity observed in in vitro and in vivo models. Despite a relatively limited number of post‐marketing studies describing its effectiveness, fenspiride was authorized in several European countries and had been used for decades for the treatment of respiratory diseases 4–7 . On May 29th, 2019, The European Medicine Agency's (EMA) Co‐ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) withdrew the marketing authorizations for fenspiride containing medicines due to the potential risk of QT prolongation and proarrhythmia.…”

“…Despite a relatively limited number of post-marketing studies describing its effectiveness, fenspiride was authorized in several European countries and had been used for decades for the treatment of respiratory diseases. [4][5][6][7] On May 29th, 2019, The European Medicine Agency's (EMA) Co-ordination Group for Mutual Recognition and Decentralised Procedures -Human (CMDh) withdrew the marketing authorizations for fenspiride containing medicines due to the potential risk of QT prolongation and proarrhythmia. The assessment procedure under Article 107i of Directive 2001/83/EC was initiated due to the occurrence of five case reports where QT prolongation and fatal and non-fatal Torsade de Pointes (TdP) events arose.…”