BARCELONA, Spain and ATLANTA, Aug. 29, 2016 /PRNewswire/ -- Laboratorios SALVAT S.A. (SALVAT) and Arbor Pharmaceuticals, LLC (Arbor) jointly announce the launch of OTOVEL® (ciprofloxacin 0.3 % and fluocinolone acetonide 0.025 %) otic solution, the first and only antibiotic and steroid combination ear drop available in sterile, preservative-free single-dose vials. OTOVEL® is owned by SALVAT, and Arbor will be the exclusive distributor of the product in the U.S.
"We are very pleased to be partnering with SALVAT to represent OTOVEL® in the U.S.," said Ed Schutter, President and CEO of Arbor. "OTOVEL® is a perfect fit with our other pediatric products that are sold by our team of over 200 sales professionals throughout the country."
"It is exciting to further expand the international commercial availability of OTOVEL® through the partnership with Arbor in the U.S.," said Alberto Bueno, CEO of SALVAT. "This new launch of OTOVEL® is a major milestone for SALVAT as we continue to grow our presence in the U.S. market."
OTOVEL® (ciprofloxacin 0.3 % and fluocinolone acetonide 0.025 %) is indicated for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients (aged 6 months and older) due to S. aureus, S. pneumoniae, H. influenzae, M. catarrhalis, and P. aeruginosa. Two phase 3 multicenter, randomized, double-blind, active-controlled, parallel group trials were conducted to assess the efficacy and safety of OTOVEL® compared to ciprofloxacin otic solution and to fluocinolone acetonide otic solution. In total 662 pediatric patients (aged 6 months to 12 years old) with AOMT were included. In both trials, the OTOVEL® treatment arms showed significantly shorter times to cessation of otorrhea in comparison to both the ciprofloxacin and fluocinolone acetonide alone arms. In Study 1 and Study 2 the median time to cessation of otorrhea in the OTOVEL® group was 3.75 and 4.94 days, respectively, compared to 7.69 and 6.83 days in the ciprofloxacin alone group1.
OTOVEL® is packaged in sterile, single-use vials, with each vial containing a delivery volume of 0.25 mL sterile, preservative-free solution. OTOVEL® is promoted and distributed by Arbor and is now available nationwide.
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Last updated on: 29/08/2016
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