Neos Therapeutics Inc’s drug to treat a common type of childhood behavioral disorder was approved by the U.S. Food and Drug Administration, making it the first of its kind to win U.S. approval.
The drug, Adzenys XR-ODT, is approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged six and older. The drug is an orally disintegrating tablet and a longer-acting version of amphetamine, a commonly prescribed ADHD drug.
ADHD is a condition with symptoms such as poor concentration, hyperactivity and learning difficulties.
The disorder affects about 4.1 percent of American adults aged 18 years and older in a given year and 9 percent of children aged 13-18 years, according to the National Institute of Mental Health.
The company said product launch and shipments will begin in the second quarter of 2016.
The approval is backed by certain data which addresses issues raised by the FDA when it rejected the drug in 2013.
RBC Capital analysts said the approval is an important event for Neos on a product where they see an adjusted per-share value of $22 versus the existing equity value of about $10.
The Texas-based company, which debuted on July 23, is focused on developing longer-acting treatments, particularly to address the ADHD market.