Sciele Pharma, Inc, a specialty pharmaceutical company, and Addrenex Pharmaceuticals, announced the initiation of patient enrolment for phase III clinical trials in the US for Clonicel to treat attention deficit and hyperactivity disorder (ADHD) in children.
In July 2007, Sciele signed an exclusive licensing agreement with Addrenex to market a sustained-release formulation of clonidine hydrochloride for the treatment of ADHD and hypertension.
Patrick Fourteau, president and chief executive officer, Sciele Pharma, said, "We are pleased that Addrenex has initiated patient enrolment for the Phase III trial using Clonicel to treat ADHD. Clonicel is an excellent strategic fit for our paediatric product portfolio. Sciele has significantly expanded its product pipeline during the past year, and we now have five products in Phase III clinical trials. Two other products are currently under review at the FDA."
"We are excited about the benefits Clonicel may provide children between the ages of 6 and 17 who have ADHD. This is the first Phase III clinical trial that is being conducted using a new formulation of clonidine for the treatment of ADHD. Clonicel is a 12-hour, sustained-release formulation, which is designed to reduce the side effects of clonidine," said, Moise Khayrallah, chief executive officer, Addrenex.
Sciele Pharma, Inc. is a pharmaceutical company specializing in sales, marketing and development of branded prescription products focused on Cardiovascular/Metabolic, Women's Health and paediatrics. The company's Cardiovascular/Metabolic products treat patients with high cholesterol, hypertension, high triglycerides, unstable angina and Type 2 diabetes; its Women's Health products are designed to improve the health and well-being of women and mothers and their babies; and its paediatrics products treat allergies, asthma, coughs and colds, and attention deficit/hyperactivity disorder (ADHD).
Founded in 1992 and headquartered in Atlanta, Georgia, Sciele Pharma employs more than 900 people. The company's success is based on placing the needs of patients first, improving health and quality of life, and implementing its business platform - an Entrepreneurial Spirit, Innovation, Speed of Execution, Simplicity, and Teamwork.