said Wednesday that a Phase III clinical trial to evaluate the safety and efficacy of its adult attention deficit disorder/attention deficit hyperactivity disorder drug, Focalin LA, has been initiated.
Celgene, based in Warren, N.J., said that
, which currently has marketing rights to the drug in the U.S., will carry out the multicenter trial. In the trial, Focalin LA will be administered once a day to adult patients with ADD/ADHD.
Recently, shares of Celgene were up 1.3% at $39.90. Novartis was falling 0.6% at $39.05.
Focalin is a refined form of Ritalin, which has been approved by the Food and Drug Administration for the treatment of ADD/ADHD in children and adolescents. Focalin LA is an extended release version of Focalin.
Celgene licensed the worldwide rights, excluding Canada, to Focalin and Focalin LA to Novartis in 2000 in exchange for milestone payments and royalties on Focalin and the Ritalin family of drugs, including Ritalin, Ritalin LA, Ritalin SR and eventually Focalin LA.