The company has received the US Food and Drug Administration approval for Cuvposa in July 2010 on the basis of a Phase III study of 38 subjects which showed that 75% of children and adolescents treated with Cuvposa experienced an improvement in symptoms, versus 11% who received placebo.
Shionogi will sign a partnership with Diplomat Specialty Pharmacy to grant caregivers convenient access to the newly-available treatment via a patient’s physician.
Shionogi chief medical officer Donald Manning said unlike tablet formulations, liquid Cuvposa does not require compounding by a pharmacist before it is administered by caregivers, providing families with a new approach to treating chronic severe drooling in children and adolescents with neurologic conditions.