Addrenex reports proposed drug counters attention-deficit hyperactivity disorder

Durham, N.C. — Pharma startup Addrenex says a drug it is developing in partnership with Sciele Pharma (Nasdaq: SCRX) in Atlanta “significantly” reduced a variety of symptoms of attention-deficit hyperactivity disorder.

The drug, called Clonicel, “achieved statistically significant improvement” over placebo in the Phase III clinical trial, Addrenex reported Thursday.

Sciele invested $6 million in Addrenex last fall and is partnering with the Durham company on a number of drug candidates. If the U.S. Food and Drug Administration approves the drug, Sciele would market and sell it.

"This is the first study to validate the potential for a long-acting version of clonidine – a widely used hypertension drug – as a safe and effective treatment for ADHD," Moise Khayrallah, chief executive officer of Addrenex, said in a statement.

According to Addrenex, Clonicel was developed to counter not only ADHD symptoms but also side effects of clonidine, such as drowsiness. ADHD is linked to the body’s adrenergic system that produces adrenaline.

Symptoms include emotional outbursts, mood swings, insomnia and hyperreactivity to stress, the company noted.

"We conducted a well-powered, randomized clinical trial to demonstrate that Clonicel may be effective on its own in treating a multitude of ADHD symptoms, with a favorable side effect profile," Khayrallah said. "We're very excited with the positive data we obtained, and we intend for this study to serve as part of the basis for review and approval by the FDA, hopefully by next year."

The clinical trial included 228 children between ages of 6 and 17 who have been diagnosed with ADHD.

Joseph Horacek, a neuropsychiatrist and a co-founder of Addrenex, designed a scale used in the trial to track symptoms and effects of Clonicel compared with placebo.

"We believe that Clonicel is normalizing the excess of the adrenergic hormones that contribute to many of the symptoms of ADHD," Horacek said.

Another clinical trial involving Clonicel is testing the effects of the compound when used in conjunction with stimulates to see if a combination is more effective.

Addrenex is also developing a hypertension drug.