Study shows Clonicel(R) and stimulants combined provide greater improvement in symptoms than stimulants alone

DURHAM, N.C., April 23 /PRNewswire/ -- Addrenex Pharmaceuticals, Inc. today announced positive results from a second phase 3 trial of Clonicel demonstrating that the combination of Clonicel with stimulant medications provided statistically significant improvements in attention deficit hyperactivity disorder (ADHD) symptoms compared to stimulant use alone.

Clonicel is the company's lead compound in a pipeline of products that have shown clinical success in alleviating conditions arising from an overactive adrenergic system, the body's control center for regulating stress and a host of other physiologic functions. The Durham-based specialty pharmaceutical company is also developing drugs to treat hypertension, menopausal flushing and potentially insomnia, pain, and migraines.

Based on the positive data from two Phase 3 trials conducted on Clonicel, Addrenex plans to seek approval from the U.S. Food and Drug Administration 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 3 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," 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 3 trial in a year to investigate the safety and efficacy of Clonicel, a long-acting version of clonidine hydrochloride. 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. 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. Scientists have hypothesized that the adrenergic system is overactive in a subset of children with ADHD. Adrenergic dysregulation also may play a major role in a host of adult conditions such as post-traumatic stress syndrome, menopausal flushing, hypertension, and migraines.

About Addrenex

Addrenex specializes in the development of drugs, diagnostic tools and intervention methods aimed at normalizing adrenergic function and thereby helping patients regain control of symptoms related to adrenergic dysregulation. Adrenergic dysregulation is the root cause or major contributing factor for multiple medical conditions. Currently, Addrenex has three products in clinical trials and a library of over 400 compounds available for future development. For more information go to www.addrenex.com.

SOURCE Addrenex Pharmaceuticals, Inc.