Addrenex Scores in ADHD Trial

Durham-based drug development firm Addrenex Pharmaceuticals has reported positive results from a second Phase III trial of drug candidate Clonicel, which it hopes to market to treat attention deficit hyperactivity disorder (ADHD).

The 3-year-old company, founded with the help of $160,000 in loans from the North Carolina Biotechnology Center, said the clinical study demonstrated that a combination of Clonicel with stimulant medications provided statistically significant improvements in 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.

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.

Addrenex is also developing drugs to treat hypertension, menopausal flushing, and potentially insomnia, pain, and migraines.

Thu, 04/23/2009 - 04:00