Concerta methylphenidate: Phase III data; NDA under review

In a U.S. Phase III crossover trial of once daily Concerta in 64 children with ADHD, significant improvement in inattention and overactivity score was seen with Concerta-treated patients, as well as with patients given conventional methylphenidate three times a day compared to placebo. Concerta and conventional methylphenidate had similar onset of action and duration, and similar safety profiles. Data were presented at the Pediatric Academic Societies and American Academy of Pediatrics joint meeting in Boston.

Concerta is being developed by AZA on behalf of Crescendo Pharmaceuticals Corp. (CNDO, Palo Alto, Calif.). Separate Phase III data for Concerta were previously reported (see BioCentury, May 8). ...