New ADHD Treatment Arriving This Summer

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New ADHD Treatment Arriving This Summer
New ADHD Treatment Arriving This Summer

Rhodes Pharmaceuticals has 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. 

The drug 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 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 seven dosage strengths — 10mg, 15mg, 20mg, 30mg, 40mg, 50mg, and 60mg strengths. Rhodes is hoping that the relatively large number of dosage strengths will allow for more personalized treatment and will allow clinicians to fine tune the appropriate strength for each patient.

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 apple sauce.

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