The current study of 200 children with attention deficit hyperactivity disorder (ADHD) is the second Phase III trial in a year to investigate the safety and efficacy of Clonicel, a long-acting version of clonidine hydrochloride. The multi-center, placebo-controlled, double-blind, randomized trial was funded by Addrenex Pharmaceuticals.
Both studies demonstrated that Clonicel improves an aggregate of 18 ADHD symptoms recognized by the American Psychiatric Association and used by doctors to diagnose and classify ADHD in children and adolescents. In both studies, Clonicel showed improvement across all three symptom domains of ADHD: attention, hyperactivity, and impulsivity. Clonicel was well-tolerated and had a favorable safety profile, with mild adverse events such as drowsiness, said Addrenex.
Based on the positive data from two Phase III trials conducted on Clonicel, Addrenex plans to seek approval from the FDA later in 2009 for Clonicel as both a monotherapy and as an add-on therapy to stimulant medication for children and adolescents with ADHD. The North American rights to market Clonicel are licensed to Sciele Pharma, a Shionogi company, which is an Atlanta-based specialty pharmaceutical company.
Moise Khayrallah, CEO of Addrenex, said: “Our data from the first Phase III study strongly suggest that Clonicel is an effective therapy for ADHD when used alone, and now we have evidence from a second study that Clonicel also has a complementary effect when used with stimulants. In children who are not receiving optimal benefit from stimulants such as methylphenidate or amphetamine, Clonicel may provide greater relief than using a stimulant medication alone.”