Celgene Corporation announced that a pivotal clinical trial of Focalin LA (dexmethylphenidate hydrochloride extended-release capsules) in adults with attention deficit disorder / attention deficit hyperactivity disorder (ADD/ADHD) has been initiated. Novartis Pharmaceuticals Corporation has marketing rights to Focalin LA in the United States and will conduct the multi-center, controlled pivotal trial to evaluate the safety and efficacy of Focalin LA administered once daily in adult patients with ADD/ADHD.
Attention deficit disorder/attention deficit hyperactivity disorder is a recognized medical disorder characterized by persistent symptoms of inattention, hyperactivity and impulsivity. In recent years, interest in the adult outcomes of ADD/ADHD children has increased in research, clinical and public arenas. Recent studies provide evidence that the persistence of untreated ADD/ADHD into adulthood tends to be associated with poor adult functions or outcomes in one or more life areas such as education, occupation, financial or social. In a recent clinical trial in adult ADD/ADHD patients, subjects treated with methylphenidate experienced a decrease in ADD/ADHD symptoms.
"We are very pleased that our partner Novartis has initiated this pivotal trial to evaluate Focalin LA, the long-acting formulation of Focalin, as a potential treatment for adults affected by the serious symptoms of ADD/ADHD," said Sol J. Barer, President and Chief Operating Officer of Celgene Corporation.
Focalin (dexmethlyphenidate hydrochloride) containing only the effective d-isomer, is a refined form of Ritalin (d,l-thero-methlyphenidate hydrochloride), which provides similar efficacy and a favorable side effect profile at half the Ritalin milligram dosage. Both Focalin and Ritalin have been approved by the FDA for the treatment of ADD/ADHD in children and adolescents. Focalin LA, an extended release version, is intended to be dosed once-daily. Focalin LA is currently being evaluated in clinical trials for efficacy and safety in adults and children for future regulatory applications.
Celgene licensed the worldwide rights (excluding Canada) to Focalin and Focalin LA to Novartis Pharma AG in exchange for milestone payments and royalties on Focalin and the entire Ritalin family of drugs including Ritalin, Ritalin LA, Ritalin SR and ultimately Focalin LA. Pursuant to an agreement between Novartis Pharma AG and Novartis Pharmaceuticals Corporation, Novartis Pharmaceuticals Corporation has marketing rights to Focalin and Focalin LA in the U.S. Celgene retained the rights to Focalin for oncology-related indications. Focalin LA uses SODAS technology, a proprietary drug delivery technology of Elan.