CMDh endorses revocation of authorisations for fusafungine sprays used to treat airway infections CMDh endorses revocation of authorisations for fusafungine sprays used to treat airway infections | European Medicines Agency Skip to main content Search Search Menu * Medicines Medicines * Search * Download * What we publish and when * Medicines under evaluation of EMA * Careers * Procurement * Glossaries * About this website * Data protection and privacy * FAQs * Contacts CMDh endorses revocation of authorisations for fusafungine sprays used to treat airway infectionsPress release01/04/2016 The CMDh1 has endorsed by consensus the revocation of marketing authorisations for fusafungine sprays in the EU. This follows
. Participants were randomised to three treatment groups: Group 1: seven-day course of fusafungine (six times a day by inhalation); Group 2: seven-day course of fusafungine (six times a day by inhalation) plus clarithromycin (250 mg twice daily for seven days); Group 3: no treatment. Clinical cure rates were measured at days 5 ± 1, 8 ± 1 and 28 ± 2. The authors reported significant differences in the rates of clinical cure at day 5 ± 1 favouring fusafungine (one trial; 93 participants; RR 1.50, 95% CI 1.02 to 2.20; P value = 0.04) and fusafungine plus clarithromycin (one trial 97 participants; RR 1.47, 95% CI 1.00 to 2.16; P value = 0.05) when compared to no treatment. However, no significant differences were found at days 8 ± 1 and 28 ± 2. Also, no significant differences were found when comparing
[The potential of prophylaxis and optimization of the treatment of rhinosinusitis in the children presenting with stenosing laryngotracheitis]. The objective of the present work was to estimate the clinical, prophylactic, and microbiological effectiveness of fusafungine applied for the treatment of acute rhinosinusitis (ARS) in the children that develops as a consequence of acute stenosing laryngotracheitis. The study included 61 children presenting with ARS and concomitant acute stenosing laryngotracheitis (ASLT) that were treated with fusafungine (Bioparox). Both tolerance and safety of this preparation were evaluated. Fusaferine was prescribed after reduction of pharyngeal stenosis. The children were divided into two groups. Group 1 was comprised of the patients with the respiratory symptoms
Scintigraphic assessment of the oropharyngeal and nasal depositions of fusafungine from a pressurized inhaler and from a novel pump spray device. The distributions of fusafungine (Locabiotal, Servier) radiolabelled with 99mTc, and delivered either orally or intranasally, have been assessed in healthy volunteers from a pressurized metered-dose aerosol inhaler (125 micrograms per dose) and from ), was greater with the pump spray for both oral and nasal dosing. The area of deposition with the nasal pump spray extended into the turbinates in six of nine subjects, compared with only three of nine subjects for the pressurized aerosol. The data suggest that the distribution patterns of pump sprays and pressurized aerosols of fusafungine in the oropharynx and in the nasal passages are similar
[Inhalational antibacterial therapy for an exacerbation of chronic obstructive pulmonary disease]. The clinical efficiency of inhalational antibacterial therapy for Stage II chronic obstructive pulmonary disease (COPD) was evaluated in 100 patients who had been randomized to an inhalational fusafungine group (n = 50) and a systemic (per os or parenteral) antibiotics group (n = 50). Inhalational
The effect of fusafungine on post-operative pain and wound healing after pediatric tonsillectomy. To investigate the effect of fusafungine spray on pain and healing process after pediatric tonsillectomy. Sixty children with ages between 4 and 14 years underwent tonsillectomy or adenotonsillectomy. The patients were randomly divided into three groups and each group consisted of 20 patients. Group 1 was treated with antibiotic (amoxicillin-clavulanic acid) plus analgesic (acetaminophen), group 2 was treated with fusafungine plus analgesic (acetaminophen) and group 3 was treated with only fusafungine. The average ages were 7.8 + 3.4, 6.6 + 2.9, and 8.2 + 3.7 for groups 1, 2, and 3, respectively. Clinical evaluations were made after the operation on the 1st (T1), 3rd (T3), 7th (T7), 10th (T10
[Fusafungine after tonsillectomy]. Postoperative period after tonsillectomy is characterized by inevitable discomfort for the patient. The aim of the study was to estimate whether fusafungine in spray has an effect on healing process after the operation, especially on pain and consumption of analgesics. A prospective open, randomized study was performed on 68 patients (age 15 - 55) undergoing tonsillectomy for chronic tonsillitis. Except of standard postoperative therapy 34 patients received fusafungine in spray 4 times daily and 34 patients served as a control. Pain score in the morning and in the evening, consumption of analgesics and visual estimation of wound healing in the tonsillar fossa was evaluated. Fusafungine in spray significantly reduces pain in the early days (2 - 4 day) after
Topical treatment of rhinosinusitis with fusafungine nasal spray. A double-blind, placebo-controlled, parallel-group study in 20 patients. In a monocenter, placebo-controlled, double-blind, parallel-group study, 20 patients with acute symptoms of rhinosinusitis were treated with either fusafungine (CAS 1393-87-9, Locabiosol Dosier-Spray) (n = 10) or placebo nasal spray (n = 10). One patient from , and endoscopy) as well as scores recorded by the investigator on 6 consecutive visits before and after 1, 3, 7, 10, and 14 days of treatment, and by the patients on a diary card. Drug safety was evaluated on the basis of twice-daily assessment of general well-being and side effects. Statistical analysis of the data evidenced a positive effect of fusafungine as early as by the first 24 h of treatment
Therapeutic efficacy and clinical acceptability of fusafungine in follicular pharyngitis. Eighty-one patients suffering from follicular pharyngitis were treated for 7 days in a double-blind, multicentre controlled study of fusafungine versus placebo. Evaluations were performed at inclusion, after 7 days of treatment, and 3 weeks after the end of the treatment. The effects of the pharyngitis on day-to-day life, changes in symptoms, morphological changes of lesions, and general changes observed by the investigator and expressed by the patient were the parameters evaluated at each visit. Results confirmed the efficacy of fusafungine in the treatment of local and symptomatic manifestations of follicular pharyngitis. Effects of follicular pharyngitis on day-to-day life decreased after 7 days
Efficacy of fusafungine in acute rhinopharyngitis: a pooled analysis. Upper respiratory tract infections are generally mild but they are associated with an enormous loss in productivity. Treatment consists of reduction of local symptoms e.g. local inflammation and prevention of potential superinfections. Besides its bacteriostatic activity against most micro-organisms involved in respiratory tract infections fusafungine displays original anti-inflammatory properties. To optimise nasal and throat deposition, a new fusafungine oro-nasal spray using HFA 134a was developed and its efficacy was evaluated in patients with acute rhinopharyngitis based on improvement of significant nasal symptoms. Three randomised double-blind placebo-controlled parallel-group studies with identical objectives