Ear Infections

October 13, 2014

Salvat released results from two phase III studies comparing Ciprofloxacin 0.3% plus Fluocinolone Acetonide 0.025% Otic Solution 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). The two identical studies followed a three-arm, multi-center, randomized, double-blind design to compare the efficacy and safety of the combination to that of the components alone when administered twice a day during seven days in children (six months to 12 years old) with AOMT. The studies were performed in U.S., 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 (p<0.001 in one study and p<0.05 in the other) and to Fluocinolone alone (p<0.001 in both studies). Results also showed sustained microbiological cure was met in both trials by demonstrating statistical differences between the combination and Fluocinolone (p<0.001 in each trial). The company plans to submit an NDA to the FDA.

July 28, 2014

Otonomy reported results of phase III trials of AuriPro in a combined total of 532 pediatric patients with bilateral middle ear effusion requiring tympanostomy tube placement. The randomized, double-blind, sham-controlled phase III studies enrolled subjects ages six months to 17 years old, across approximately 60 trial sites in the U.S. and Canada. AuriPro achieved the primary efficacy endpoint with statistical significance (p<0.001). The primary endpoint of the studies was the effectiveness of AuriPro as measured by the cumulative proportion of study treatment failures through day 15, which is defined as the presence of otorrhea (drainage) or use of antibiotic rescue medication. AuriPro was well-tolerated.