Addrenex files for approval of attention deficit hyperactivity disorder drug
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DURHAM, N.C. – A new drug could be on the way to treat patients suffering from attention deficit hyperactivity disorder, or ADHD.
Addrenex Pharmaceuticals and its development partner Sciele Pharma filed a new drug application with the U.S. Food and Drug Administration this week. In Phase III clinical trials the drug, called Clonicel, showed “statistical significance” in treatment of children and adolescents, Addrenex said.
The drug is the startup company’s lead in a series of compounds based on treatment of the body’s adrenergic system which helps deal with stress and other functions.
Moise Khayrallah, chief executive officer at Addrenex, called the filing “an important milestone for physicians and the millions of patients and their families seeking a non-stimulant alternative for the treatment of ADHD.”
Addrenex has four products in clinical trials and more than 400 compounds it might pursue for treatment of hypertension, narcolepsy, procedural sedation, insomnia, menopausal flushing and dermatologic indications.
Sciele, which is based in Atlanta, owns the North American rights to market Clonicel.
Sciele invested $6 million in Addrenex as part of that deal in 2007.
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