Results from data presented support the safety and efficacy of Focalin LA (dexmethylphenidate extended release) capsules, an investigational treatment for Attention-Deficit/Hyperactivity Disorder (ADHD), in managing symptoms of the disorder in adults.
In the study, patients taking Focalin LA showed significant improvements in ADHD symptoms compared to patients taking placebo and Focalin LA was well-tolerated during the study. The study was presented at the 157th Annual meeting of the American Psychiatric Association (APA).
Focalin (dexmythylphenidate), a refined formulation of methylphenidate was introduced in 2001. Methylphenidate HCl, is one of the most extensively studied and prescribed treatments for ADHD. Focalin contains only the d-isomer, which is responsible for the effective management of the symptoms of ADHD. Focalin LA, which is in Phase III trials, is a longer acting formulation of Focalin.
"We are extremely encouraged by the results of this study investigating various doses of Focalin LA compared to placebo to manage the symptoms of ADHD in adults," said Sol J. Barer, Ph.D, president and chief operating officer of Celgene Corporation. "These results underscore the future global potential of Focalin LA, and our partnership with Novartis as we rapidly approach our next milestone, an NDA submission for Focalin LA later this year."
The double-blind, placebo-controlled study included 184 adults with a diagnosis of ADHD. All subjects reported experiencing symptoms consistent with ADHD beginning in childhood. Patients were randomized to receive one of three doses of Focalin LA or placebo once daily for five weeks. Study groups included Focalin LA 20 mg, Focalin LA 30 mg, Focalin LA 40 mg, or placebo. Efficacy was measured using the Diagnostic and Statistical Manual-IV (DSM-IV) ADHD Rating Scale, a standard assessment tool used in ADHD clinical trials.