NEW YORK, Jan 28 (Reuters Health) -- Ascent Pediatrics, Inc., said on
Thursday that it had received Food and Drug Administration (FDA) approval to
market an oral antibiotic solution for treating middle ear infections in
children aged 6 months to 12 years.
The prescription product contains the antibiotic trimethoprim and is
called Primsol Solution. Although other liquid antibiotic solutions (Septra,
Bactrim) contain the antibiotic trimethoprim, they also contain
sulfamethoxazole, which in rare cases may cause a severe allergic reaction in
children, according to the company.
"Ascent has proven that a sulfa component isn't needed for efficacy in the
treatment of acute otitis media (ear infection)," said Dr. Emmett Clemente,
president and chairman of Wilmington, Massachusetts-based Ascent Pediatrics.
"Primsol was shown to have significantly fewer side effects," he added.
Primsol is Ascent's first prescription drug to receive marketing approval
and will be available in February and March. The company estimated that
pediatric otitis media accounts for more than 23 million visits to pediatricians
in the US every year.
