FDA clears Curemark's CM – 4612 IND for Phase III clinical trial in ADHD

Aug 11 2010

Curemark, LLC (www.curemark.com), a drug research and development company focused on the treatment of neurological diseases, announced that the U.S. Food and Drug Administration (FDA) has given clearance to Curemark's Investigational New Drug (IND) application for a Phase III clinical trial for the use of CM – 4612 in the treatment of attention deficit hyperactivity disorder (ADHD).  

Currently, Curemark is conducting Phase III clinical trials for CM-AT, its autism treatment targeted to enzyme deficiencies in autistic children.  The lack of these enzymes affects the availability of amino acids, the building blocks of chemicals essential for brain function.

"We are very excited to have received IND clearance from the FDA so that we can move forward with clinical trials to study CM - 4612," said Dr. Joan Fallon, Curemark founder and CEO.  "Curemark hopes to have the first physiologically-based medication to address ADHD, in lieu of the current psychotropic and stimulant treatments."

According to statistics from the Centers for Disease Control and Prevention (CDC), 3% to 7% of school-aged children in the United States suffer from ADHD, accounting for an overall total of 4.5 million U.S. children.

Curemark is conducting Phase III clinical trials for its CM-AT autism treatment at 13 sites across the country with a total planned enrollment of 170 children. With regard to its regulatory filing program, CM-AT has received Fast Track review status from the FDA.