Study of ciprofloxacin plus fluocinolone acetonide meets endpoints in Otitis Media - Lab Salvat

Laboratorios SALVAT announced the top-line results from two Phase III studies comparing ciprofloxacin plus fluocinolone acetonide to the components alone (Ciprofloxacin 0.3% otic solution and Fluocinolone Acetonide 0.025% otic solution) in the treatment of pediatric patients with Acute Otitis Media with Tympanostomy tubes (AOMT). Results showed that the primary study endpoint was met in both studies, by demonstrating a statistically significant reduction in the time to cessation of otorrhea in patients treated with the combination when compared to ciprofloxacin alone and to fluocinolone acetonide alone. The studies compared the efficacy and safety of the combination in children (6 months to 12 years old) with AOMT. The studies were performed in US, Canada, Europe and South Africa, with 331 patients recruited in each trial (662 patients in total).

For the primary efficacy parameter, time to cessation of otorrhea, a significant reduction was observed when comparing the combination to Ciprofloxacin alone and to Fluocinolone alone). The results also showed that the principal secondary endpoint, sustained microbiological cure, was met in both trials by demonstrating statistical differences between the combination and Fluocinolone. The number of patients who experienced related adverse events during the two studies was low in all three treatment groups (Ciprofloxacin plus Fluocinolone Otic Solution 4.9%, Ciprofloxacin alone 4.1% and Fluocinolone alone 6.6%), being most of them mild and recovered at the end of the study. No serious related adverse event was reported in the studies. Complete results from these studies will be available for presentation at upcoming congresses and submitted for publication in a peer-reviewed journal.