Cetraxal Plus (EU), Otovel (US) · Otitis externa and otitis media (with tympanostomy tubes) in patients aged 6 months and above
Development and Regulatory status
Jul 18: Approved by MHRA for use in adults and in children aged 6 months and older for acute otitis externa (AOE) and acute otitis media in patients with tympanostomy tubes (AOMT) caused by ciprofloxacin susceptible microorganisms .
Aug 16: Is already available in Spain, Sweden, Greece, Finland and other EU countries (not UK) .
Aug 16: Otovel launched in US .
Apr 16: US FDA approves ciprofloxacin/fluocinolone otic solution (Otovel) for acute otitis media with tympanostomy tubes in paediatric patients, aged 6 months and older .
Jun 15: Filed in US .·
Trial or other data
Sep 14: Primary and secondary endpoints were met in the two identical randomised PIII trials in a total of 662 paediatric patients with AOMT. Time to cessation of otorrhea (primary endpoint) was significantly reduced in patients who received ciprofloxacin/fluocinolone otic solution, compared to those who received ciprofloxacin alone (p<0.001 in one trial, and p<0.05 in the other) and to fluocinolone alone (p<0.001 in both trials). Sustained microbiological cure (they key secondary endpoint) was met in both trials, with significant differences between the combination treatment and fluocinolone (p<0.001 for both trials). The trials enrolled patients aged 6 months to 7 years, who were dosed twice-daily for 7 days .
Sep 14: Positive results reported from PIII trials (NCT01395966 and NCT01404611) .
H1 11: Two PIII trials to assess the efficacy and safety of ciprofloxacin/fluocinolone otic solution, compared to each agent alone, in paediatric patients with acute, moderate to severe otitis media with tympanostomy tubes (AOMT) start. The primary endpoint for both trials is time to cessation of otorrhoea, assessed over 7 days. The secondary endpoint is sustained microbiological cure. The first trial (NCT01395966) is recruiting in the US, Canada, Finland, Spain, Sweden, Denmark and the Czech Republic; the second trial is recruiting in Finland, Spain, Sweden, Denmark and South Africa (NCT01404611). Each trial is enrolling 331 patients aged 6 months to 7 years .·