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FDA Approves Adhansia XR
We are always in need of a new formulation of stimulant medication that might capture a few more of our patients who just do not quite tolerate or respond well enough to the many existing formulations. So whenever a new one is released, we try to set aside our natural skepticism and take a look at the stated facts before judging its merit.
Adhansia XR is a new formulation of extended-release methylphenidate approved by the FDA for the treatment of ADHD in patients 6 years and older. Adhansia XR capsules contain both immediate-release (IR) and extended-release (ER) beads of methylphenidate, in an IR/ER ratio of 20/80. By comparison, IR/ER ratios of other long-acting methylphenidate products are:
Aptensio XR 40%/60%, Concerta 22%/78%, Cotempla XR-ODT 25%/75%, and Focalin XR 50%/50% (dexmethylphenidate). Adhansia’s composition implies it will have a long duration of effect, and initial studies showed efficacy up to 16 hours.
Approval was based on 4 clinical studies, 1–4 weeks in duration, which showed efficacy for ADHD symptoms in both children and adults. The most common side effects of Adhansia XR were decreased appetite, insomnia, and weight loss in children, and insomnia, dry mouth, and decreased appetite in adults.
Adhansia XR will be available in 6 strengths (25, 35, 45, 55, 70, and 85 mg capsules, which may all be opened and sprinkled), and recommended dosing is to start 25 mg QAM (ages 6 and up) and increase in increments of 10–15 mg in intervals of 5 days or more. Dosages as high as 85 mg/day in pediatric patients and 100 mg/day in adult patients have been studied, but doses greater than 70 mg/day in children and 85 mg/day in adults were associated with greater adverse effects.
CCPR’s Take
It is possible that if the 16-hour duration holds, Adhansia may prove useful for families who never seem to remember the afternoon booster that many patients need to get through homework at the end of a long day. However, the news of note here is that Adhansia is likely another “me too” formulation, and it is important to stand clear of the hype and wait for more research, if it is forthcoming.
Child PsychiatryAdhansia XR is a new formulation of extended-release methylphenidate approved by the FDA for the treatment of ADHD in patients 6 years and older. Adhansia XR capsules contain both immediate-release (IR) and extended-release (ER) beads of methylphenidate, in an IR/ER ratio of 20/80. By comparison, IR/ER ratios of other long-acting methylphenidate products are:
Aptensio XR 40%/60%, Concerta 22%/78%, Cotempla XR-ODT 25%/75%, and Focalin XR 50%/50% (dexmethylphenidate). Adhansia’s composition implies it will have a long duration of effect, and initial studies showed efficacy up to 16 hours.
Approval was based on 4 clinical studies, 1–4 weeks in duration, which showed efficacy for ADHD symptoms in both children and adults. The most common side effects of Adhansia XR were decreased appetite, insomnia, and weight loss in children, and insomnia, dry mouth, and decreased appetite in adults.
Adhansia XR will be available in 6 strengths (25, 35, 45, 55, 70, and 85 mg capsules, which may all be opened and sprinkled), and recommended dosing is to start 25 mg QAM (ages 6 and up) and increase in increments of 10–15 mg in intervals of 5 days or more. Dosages as high as 85 mg/day in pediatric patients and 100 mg/day in adult patients have been studied, but doses greater than 70 mg/day in children and 85 mg/day in adults were associated with greater adverse effects.
CCPR’s Take
It is possible that if the 16-hour duration holds, Adhansia may prove useful for families who never seem to remember the afternoon booster that many patients need to get through homework at the end of a long day. However, the news of note here is that Adhansia is likely another “me too” formulation, and it is important to stand clear of the hype and wait for more research, if it is forthcoming.
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