Laboratorios SALVAT S.A. and Arbor announced the launch of Otovel (ciprofloxacin and fluocinolone) otic solution, the first antibiotic and steroid combination ear drop available in sterile, preservative-free single-dose vials. Otovel is indicated for the treatment of acute otitis media with tympanostomy tubes (AOMT) in patients aged ≥6 months due to Staphylococcus aureus, S. pneumoniae, H. influenzae, M. catarrhalis, and P. aeruginosa.

Otovel combines ciprofloxacin, a fluoroquinolone antibacterial, and fluocinolone acetonide, a corticosteroid. Ciprofloxacin works by interfering with the enzyme DNA gyrase, which is needed for the synthesis of bacterial DNA. Fluocinolone acetonide inhibits the local biosynthesis of prostaglandins, which explains part of its anti-inflammatory efficacy. This decreases the subsequent formation and release of endogenous inflammatory mediators including prostaglandins, kinins, histamine, liposomal enzymes and the complement system.

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The safety and efficacy of Otovel was evaluated in two Phase 3, multicenter, randomized, double-blind, active-controlled, parallel group trials. In the study (n=662), Otovel was compared to ciprofloxacin otic solution and fluocinolone acetonide otic solution. For both studies, the Otovel treatment groups showed significantly shorter times to cessation of otorrhea when compared to both the ciprofloxacin and fluocinolone acetonide alone treatment arms. The median time to cessation of otorrhea in the Otovel treatment group was 3.75 days (Study 1) and 4.94 days (Study 2) vs. 7.69 days (Study 1) and 6.83 days (Study 2) in the ciprofloxacin alone group.

Otovel is preservative-free and is available as 0.3%/0.025% strength single-dose vials containing a delivery volume of 0.25mL sterile solution.

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