BARCELONA, Spain I May 28, 2013 I SALVAT announced that clinical trial enrollment has completed for the Phase III study evaluating the efficacy and safety of a new otic solution containing Ciprofloxacin and Fluocinolone in patients with Acute Otitis Media.
This Phase III study is part of the Phase III clinical program, which considers two global Phase III Studies identical in design. Both studies are randomized and double blind with the objective to assess the efficacy and safety of the combination Ciprofloxacin plus Fluocinolone Otic Solution in comparison to Ciprofloxacin alone and Fluocinolone alone, for 7 days. The main endpoint is to demonstrate therapeutic superiority of the combination relative to each component alone, for time to cessation of otorrhea in pediatric patients suffering from AOMT. The principal secondary endpoint is to demonstrate therapeutic superiority of sustained microbiological cure. Preliminary results of the study are expected to be available by early September 2013.
This first trial enrolled a total of 330 patients in 96 sites from 8 countries. The majority of patients came from US sites. The second trial is expected to complete the enrollment (330 patients) in November 2013.
Tympanostomy tube insertion is among the most common operative procedures in childhood. More than 1 million tympanostomy tube insertions are performed annually in North America, primarily in children with chronic or recurrent otitis media. About 7 percent of children in the United States have tympanostomy tubes inserted by age three years, with rates up to 30 percent reported in a managed care cohort attending day care. The most common complications reported after tube insertion include: otorrhea, the formation of granulation tissue around the tube, and cholesteatoma. The estimated incidence of Acute Otitis Media accompanied by otorrhea in patients with tympanostomy tubes ranges from 15% to 74%. With the tympanostomy tube in place, the middle ear is accessible to topical medications applied to the external auditory canal.
This novel combination will be the first supplied in single-use, sterile and preservative-free vials for the treatment of AOMT.
SALVAT is currently evaluating potential commercial partners in the United States to license out this combination and expects to file the NDA during the first quarter of 2014.
About Ciprofloxacin plus Fluocinolone
Ciprofloxacin 0.3% plus Fluocinolone 0.025% Otic Solution is a new combination intended to reach the middle ear. It will be indicated for the treatment of Acute Otitis Media in patients 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.
This combination is already approved and marketed by SALVAT in several markets for the treatment of Otitis Externa as CETRAXAL PLUS.
About SALVAT
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 and by emphasizing collaborations regarding its pipeline products such as Tarafenacin for Overactive Bladder and Eberconazole for fungal infections, among others.
SOURCE: Salvat
Post Views: 170
BARCELONA, Spain I May 28, 2013 I SALVAT announced that clinical trial enrollment has completed for the Phase III study evaluating the efficacy and safety of a new otic solution containing Ciprofloxacin and Fluocinolone in patients with Acute Otitis Media.
This Phase III study is part of the Phase III clinical program, which considers two global Phase III Studies identical in design. Both studies are randomized and double blind with the objective to assess the efficacy and safety of the combination Ciprofloxacin plus Fluocinolone Otic Solution in comparison to Ciprofloxacin alone and Fluocinolone alone, for 7 days. The main endpoint is to demonstrate therapeutic superiority of the combination relative to each component alone, for time to cessation of otorrhea in pediatric patients suffering from AOMT. The principal secondary endpoint is to demonstrate therapeutic superiority of sustained microbiological cure. Preliminary results of the study are expected to be available by early September 2013.
This first trial enrolled a total of 330 patients in 96 sites from 8 countries. The majority of patients came from US sites. The second trial is expected to complete the enrollment (330 patients) in November 2013.
Tympanostomy tube insertion is among the most common operative procedures in childhood. More than 1 million tympanostomy tube insertions are performed annually in North America, primarily in children with chronic or recurrent otitis media. About 7 percent of children in the United States have tympanostomy tubes inserted by age three years, with rates up to 30 percent reported in a managed care cohort attending day care. The most common complications reported after tube insertion include: otorrhea, the formation of granulation tissue around the tube, and cholesteatoma. The estimated incidence of Acute Otitis Media accompanied by otorrhea in patients with tympanostomy tubes ranges from 15% to 74%. With the tympanostomy tube in place, the middle ear is accessible to topical medications applied to the external auditory canal.
This novel combination will be the first supplied in single-use, sterile and preservative-free vials for the treatment of AOMT.
SALVAT is currently evaluating potential commercial partners in the United States to license out this combination and expects to file the NDA during the first quarter of 2014.
About Ciprofloxacin plus Fluocinolone
Ciprofloxacin 0.3% plus Fluocinolone 0.025% Otic Solution is a new combination intended to reach the middle ear. It will be indicated for the treatment of Acute Otitis Media in patients 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.
This combination is already approved and marketed by SALVAT in several markets for the treatment of Otitis Externa as CETRAXAL PLUS.
About SALVAT
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 and by emphasizing collaborations regarding its pipeline products such as Tarafenacin for Overactive Bladder and Eberconazole for fungal infections, among others.
SOURCE: Salvat
Post Views: 170
