Sciele Pharma, Addrenex report successful phase III study on ADHD drug

ATLANTA A phase III clinical study to investigate use of the drug Clonicel for treating attention deficit hyperactivity disorder has shown statistically significant results compared to the placebo, the drug’s makers announced Wednesday.

Sciele Pharma and Addrenex Pharmaceuticals conducted the study on 228 children aged 6 to 17 diagnosed with ADHD, giving them either a placebo or two daily 0.2 mg or 0.4 mg doses of Clonicel for eight weeks. Harmful side effects were mild to moderate in severity, but no serious side effects were reported.

Sciele and Addrenex plan to publish the results at an upcoming medical conference.

“We are pleased to announce the positive results for the phase III trial investigating the use of Clonicel to treat ADHD,” said Sciele chief medical officer Larry Dillaha.

Clonicel, known generically as clonidine, is approved for treating hypertension.