Sciele Pharma, Addrenex Submit sNDA To FDA For Clonicel

Sciele Pharma and Addrenex Pharmaceuticals have announced that Addrenex has submitted a supplemental New Drug Application (sNDA) to the FDA for Clonicel (modified-release clonidine) to treat attention deficit hyperactivity disorder (ADHD).

In multi-center, placebo-controlled, double-blind, randomised phase III clinical trials, Clonicel showed statistical significance when used to treat ADHD.

Ed Schutter, president and chief operating officer of Sciele Pharma, said: “We are pleased that Addrenex has filed the sNDA with the FDA. Clonicel is an important product in our pediatric pipeline, and we are excited about the potential benefit that Clonicel may provide to children and adolescents who have ADHD.”

Moise Khayrallah, chief executive officer of Addrenex Pharmaceuticals, said: “Clonicel was designed to normalise excess adrenergic hormones that may cause symptoms of ADHD. In phase III clinical trials, Clonicel demonstrated an improvement in an aggregate of 18 ADHD symptoms recognised by the American Psychiatric Association and used by doctors to diagnose and classify ADHD in children and adolescents.”

In July 2007, Sciele signed an exclusive licensing agreement with Addrenex to market its modified-release formulation of clonidine hydrochloride for the treatment of ADHD and hypertension in the US, Mexico and Canada.