Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Rhodes Pharmaceuticals will launch Aptensio XR, a once-daily central nervous system stimulant indicated to treat attention-deficit/hyperactivity disorder (ADHD) beginning this summer.
Subscribe to our email newsletter
Aptensio XR is an extended-release formulation of methylphenidate capsule with an onset of effect of one hour and 12-hour duration of effect with about 40% of the active ingredient released immediately and around 60% delivered later in the day.
The US Food and Drug Administration (FDA) has granted approval for Aptensio XR last month. The company said that the once-daily Aptensio XR is available in seven dose strengths of 10, 15, 20, 30, 40, 50 and 60mg.
The approval was based on data from two Phase III, randomized, double-blind, placebo-controlled trials evaluating the safety and efficacy of Aptensio XR in children and adolescents with ADHD.
Rhodes Pharmaceuticals vice-president and chief technology officer Robert Kupper said: "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.
"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."
University of California Clinical Professor of Pediatrics Sharon and Principal Clinical Trial Investigator Sharon Wigal said: "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."
Rhodes Pharmaceuticals Product Development executive director Akwete Adjei said: "As optimal treatment of ADHD is determined patient by patient, the efficacy across dosage strengths seen in the Aptensio XR data is promising.
"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."