Phase 3 study of Clonicel for ADHD

Sciele Pharma and Addrenex Pharmaceuticals announced that a preliminary analysis showed positive results from a second Phase 3 trial of Clonicel for the treatment of attention deficit and hyperactivity disorder (ADHD).  This study of 200 children with ADHD demonstrated that a combination therapy of Clonicel and stimulants provided statistically significant improvements in ADHD symptoms compared to stimulant use alone. Addrenex and Sciele Pharma plan to file an NDA later this year for Clonicel as both a monotherapy and as an add-on therapy to stimulant medication for children and adolescents with ADHD.

Clonicel is a long-acting version of clonidine HCl, 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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