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."
For more information, visit www.AptensioXR.com.
ADHD is one of the most common neurodevelopmental disorders affecting more than six million children in America. ADHD is usually first diagnosed in childhood and often lasts into adulthood. Children with ADHD may have trouble paying attention, controlling impulsive behaviors (may act without thinking about what the result will be), or be overly active.
About Rhodes Pharmaceuticals
Rhodes Pharmaceuticals L.P. is a specialty pharmaceutical company based in Coventry, Rhode Island. Rhodes Pharmaceutical's vision for success is based on a sustainable business platform, competitive costs, high-quality products, reliable supply, excellent customer service, and a vertically integrated and robust pipeline. For more information, visitwww.rhodespharma.com.
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