ATLANTA & DURHAM, N.C.-Sciele Pharma, a Shionogi Company, and Addrenex Pharmaceuticals, Inc. today announced that a preliminary analysis showed positive results from a second Phase III trial of Clonicel®, demonstrating that the combination of Clonicel with stimulants provided statistically significant improvements in ADHD symptoms compared to stimulant used alone.
Larry Dillaha, M.D., Chief Medical Officer of Sciele Pharma, said, “We are pleased with the positive Phase III results using Clonicel in combination with stimulants. Clonicel is an important product in our development pipeline, and we are excited about the potential benefit that Clonicel may provide to children and adolescents who have ADHD.”
Based on the positive data from two Phase III trials conducted on Clonicel, Addrenex and Sciele Pharma plan to file with the U.S. Food and Drug Administration (FDA) later this year 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.
“Our data from the first Phase III study data suggest that Clonicel may be 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,” said Moise Khayrallah, Ph.D., CEO of Addrenex Pharmaceuticals. “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.”
The current study of 200 children with 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. Both studies demonstrated that Clonicel improved 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. The multi-center, placebo-controlled, double blind, randomized trial was funded by Addrenex Pharmaceuticals
Clonicel is a non-stimulant medication that selectively targets and calms the adrenergic system, a cascade of stress hormones that regulate the body’s response to stress and other physiologic factors. An overactive adrenergic system can trigger emotional outbursts, irritability, mood swings and other debilitating symptoms.
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