FDA OKs Celgene and Novartis' ADHD drug

The USA's Celgene Corp and Swiss drugmaker Novartis say that the US Food and Drug Administration has granted marketing approval for Focalin XR (dexmethylphenidate HCl) extended-release capsules for the treatment of attention-deficit hyperactivity disorder in adults, adolescents and children.

"Focalin XR provides a new treatment option for adults, adolescents and children to address the many difficult symptoms of ADHD," said Thomas Spencer, associate professor of psychiatry at Harvard Medical School and assistant director of the pediatric psychopharmacology research program at Massachusetts General Hospital, USA. "Focalin XR provides patients with a treatment that starts working quickly to alleviate symptoms with the advantage of a once-daily dose that lasts throughout the entire school or work day," he added.

Clearance was based on favorable safety and efficacy data from clinical trials involving around 320 adults, adolescents and children diagnosed with ADHD. The results showed that the agent was generally well-tolerated, with no significant changes in patient weight or vital signs, the groups noted.