BARCELONA, Spain, September 29, 2014 /PRNewswire/ --
This innovative combination of drugs could become the treatment of choice in those cases
Laboratorios SALVAT S.A. announced today the top-line 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 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 two identical studies followed a 3-arm, multicenter, 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 7 days 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 (p<0.001 in one study and p<0.05 in the other) and to Fluocinolone alone (p<0.001 in both studies). 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 (p<0.001 in each trial).
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.
"With these positive top-line results we are proceeding with the additional dataset analyses we will need to submit an NDA to the FDA," said Alberto Bueno, CEO of Laboratorios SALVAT, S.A. "This represents an important milestone for SALVAT as we are closer to having second marketing authorization in the US. Our excellent track record with the product in other markets makes us believe that this innovative combination has the potential to become the treatment of choice for pediatric patients suffering from AOMT in the US."
These results are preliminary and subject to additional analyses. Complete results from these studies will be available for presentation at upcoming congresses and submitted for publication in a peer-reviewed journal.
About Ciprofloxacin 0.3% plus Fluocinolone Acetonide 0.025% Otic Solution
Ciprofloxacin 0.3% plus Fluocinolone Acetonide 0.025% Otic Solution is a new combination intended to reach the middle ear, and indicated for the treatment of Acute Otitis Media in children with tympanostomy tubes. It will be available in preservative-free, single-use containers which safeguard sterility at each dose and make it easy to ensure correct dosing and application of drops into the ear.
Acute Otitis Media with Tympanostomy Tubes (AOMT) is characterized by the presence of otorrhea, following the insertion of a tympanostomy tube into the eardrum. This insertion is a surgical procedure intended to treat the effusion that usually accompanies a middle ear inflammation, and complications appear quite commonly, being otorrhea the most frequent.
SALVAT markets different forms of its otic combination solution through its propietary sales team in Spain and through its network of licensees and distributors in the majority of the markets outside the US. The company is currently seeking licensees for the commercialization of its new otic development in the US.
Based in Barcelona (Spain), SALVAT is a privately owned pharmaceutical group closely identified with technological innovation and strongly committed to R&D. Founded in 1955 SALVAT has presence in over 60 countries worldwide in collaboration with well-reputed pharmaceutical partners. SALVAT is working to strengthen its international presence by licensing its own developments. The company launched Cetraxal® Otic, a ciprofloxacin 0.2% otic solution in the US in 2009 and is currently working on the submission to the US FDA of an NDA for its second otic development. Further information about Laboratorios SALVAT, S.A. can be found at http://www.salvatbiotech.com
Enrique Jimenez, MD