Eisai announces FDA approval for Aciphex Sprinkle

Eisai has announced its Aciphex Sprinkle treatment for gastroesophageal reflux disease in children has been approved by the US Food and Drug Administration.

The pharmaceutical company confirmed the pediatric formulation delayed-release five mg and ten mg capsule has been given the green light for periods of up to 12 weeks among patients.

As part of the development process, the formulation was designed to be administered to children by sprinkling granules of the drug on to soft foods, baby formula or fruit juices.

The medication's approval was based on a multicentre, double-blind, parallel group study that was conducted among 127 pediatric patients between the ages of one and 11 who are suffering from endoscopically proven gastroesophageal reflux disease.

Scientists conducting study carried out a 12-week treatment and a 24-week extension period of two dose levels, resulting in 81 per cent of patients recovering during the initial timeframe.

Clinical trials investigating the medication also revealed 90 per cent of subjects maintaing healing during the ensuing 24-week extension period.