Today, Rhodes Pharmaceuticals L.P. announced that Aptensio XR, a once-daily central nervous system stimulant indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) will be available to patients beginning Summer 2015.
The announcement comes just one month after Aptensio XR received approval from the U.S. Food and Drug Administration (FDA).
Aptensio XR is an extended-release formulation of methylphenidate capsule with 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.
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.
"While there are a number of treatment options available for patients with ADHD, there continues to be an unmet need as many patients struggle to achieve symptom control," said Robert Kupper, PhD, Vice President and Chief Technology Officer, Rhodes Pharmaceuticals. "We were encouraged that the Aptensio XR's extended-release formulation helped to control symptoms throughout a 12-hour day, and that it's now another option physicians may consider for their patients."
Aptensio XR was approved by the FDA based on data from two Phase III, randomized, double-blind, placebo-controlled studies evaluating the safety and efficacy of Aptensio XR in children and adolescents with ADHD. The first study, conducted at the Child Development Center, University of California at Irvine, CA "demonstrated that Aptensio XR delivered statistically significant results, from hour one to hour 12 when compared with placebo, as measured by total scores on the Swanson, Kotkin, Agler, M-Flynn, Pelham (SKAMP) Scale," said Sharon Wigal, PhD, Principal Clinical Trial Investigator and Clinical Professor of Pediatrics.
To address patients' needs for individualized treatment, once-daily Aptensio XR is available in seven dose strengths (10, 15, 20, 30, 40, 50 and 60 mg). In the second Phase III study, which included children and adolescents aged six to 17, Aptensio XR consistently demonstrated efficacy across the different doses, as measured by the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV).
"As optimal treatment of ADHD is determined patient by patient, the efficacy across dosage strengths seen in the Aptensio XR data is promising," said Akwete Adjei, PhD, Executive Director, Product Development, Rhodes Pharmaceuticals. "The seven dosing options with Aptensio XR allows doctors to fine-tune treatment based on patient needs without sacrificing control and without a further need for a midday dose of immediate-release methylphenidate to sustain safety and efficacy."
The patient-reported adverse events experienced by >2% of patients in the Phase III trials were commonly-known effects of methylphenidate including headache, insomnia, upper abdominal pain, decreased appetite, nausea, vomiting and dizziness.
"We were encouraged by the satisfactory clinical efficacy data for Aptensio XR," said Ann Childress, MD, President, Center for Psychiatry and Behavioral Medicine in Las Vegas, NV and lead investigator. "With an onset as soon as one hour and a duration of up to 12-hours, Aptensio XR will likely be viewed as a welcome new treatment option for physicians treating patients with ADHD."
"The availability of Aptensio XR is an important next step for Rhodes Pharmaceuticals," said Vincent Mancinelli II, President, Rhodes Pharmaceuticals. "We are dedicated to helping to meet patients' unmet needs and are proud that Aptensio XR will help meet the needs of those in the ADHD community."
Rhodes Pharmaceuticals L.P.