Addrenex Pharmaceuticals Reports Positive Results in Second Phase 3 Study of ADHD ...( Study shows Clonicel(R) and stimulant...),Health

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
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