Rhodes Pharmaceuticals announced that Aptensio XR (methylphenidate HCl extended-release) capsules will be available for prescribing starting Summer 2015 for the treatment of attention deficit hyperactivity disorder (ADHD). Aptensio XR is a central nervous system (CNS) stimulant with a CII controlled substance designation. Aptensio XR has an onset of effect of 1 hour and 12-hour duration of effect with approximately 40% of the active ingredient released immediately and approximately 60% delivered later in the day.
The Food and Drug Administration (FDA)’s approval of Aptensio XR was based on data from two Phase 3 randomized, double-blind, placebo-controlled trials that studied the safety and efficacy in children and adolescents with ADHD. The first study showed that Aptensio XR led to significant results from Hour 1 to 12 as measured by total scores on the Swanson, Kotkin, Agler, M-Flynn, Pelham (SKAMP) Scale vs. placebo. The second study consistently showed efficacy across the various doses as measured by ADHD Rating Scale-IV (ADHD-RS-IV).
Aptensio XR will be available as an extended-release capsule in 10mg, 15mg, 20mg, 30mg, 40mg, 50mg, and 60mg strengths. Aptensio XR can be taken with or without food. It can also be taken whole, or the capsule can be opened and the contents sprinkled onto applesauce.
For more information call (888) 827-0616 or visit AptensioXR.com.