Aptensio XR: A New ADHD Medication
A new long-acting stimulant medication designed to treat ADHD in children, Aptensio XR, is expected to be released later this summer, 2015.
September 2, 2015
A new long-acting ADHD medication known as Aptensio XR is being released this summer for children over the age of six, giving parents of children diagnosed with ADHD who choose to pursue medication an additional option for treatment.
Aptensio XR is a once-daily form of methylphenidate, with the same active ingredient found in medications like Ritalin and Daytrana. It comes in capsule form, and is available in 10mg, 15mg, 20mg, 30mg, 40mg, 50mg, and 60mg. doses. According to Rhodes Pharmaceuticals, the company that makes the new medication, Aptensio XR begins working in less than an hour, and, when used correctly, lasts for 12 hours. About 40 percent of the active ingredient is delivered immediately; the other 60 percent is delivered slowly through the rest of the day. Aptensio XR is designed to deliver two medication “peaks” when the medication’s effect is strongest – one approximately two hours after it is taken and another about eight hours later.
The drug was approved by the FDA in April 2015 after two double-blind, placebo-controlled studies on its safety and effectiveness yielded positive results. Both studies were conducted on children between the ages of six and 17, and Aptensio XR was shown to be significantly more effective than a placebo, across all dosage levels. In one study, 73.1 percent of patients were rated as “much improved” or “very much improved” on the Connors Rating Scale and the Clinical Global Impressions (CGI), the most widely-used ratings scales for ADHD symptoms. Another older study on 26 adults showed Aptensio to be as effective as three doses of short-acting methlyphenidate taken throughout the day. There were no serious side effects reported in any of the studies.
Researchers and representatives from Rhodes Pharmaceuticals hope that the many different dosing options – combined with Aptensio XR’s relatively quick onset and long duration – will make it a welcome option for people who have had difficulty optimizing treatment with other stimulant medications. The capsule can also be opened and sprinkled into yogurt or juice, an additional benefit for young children who struggle to swallow pills. Studies have shown that the medication is equally effective when mixed in food, though the timing of the medication’s “peaks” may shift slightly.
“As optimal treatment of ADHD is determined patient by patient, the efficacy across dosage strengths seen in the Aptensio XR data is promising,” said Rhodes Pharmaceuticals product development executive director Akwete Adjei. “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.”
Reported side effects of Aptensio XR are similar to other formulations of methylphenidate – decreased appetite, headache, abdominal discomfort, and insomnia. More serious, but rarer, side effects may include heart-related problems, psychiatric disorders, and slowed growth in children. Patients with preexisting heart conditions or psychiatric diagnoses should speak with their doctor before using Aptensio XR.
It’s not clear how Rhodes will be rolling out the newly approved medication. The company advises patients to call their local pharmacy to ask when Aptensio will be made available. If the pharmacy doesn’t have it, most orders should be filled within 24 hours, according to Aptensio’s website (aptensioxr.com).