First Amphetamine Transdermal Patch Approved for ADHD | Attention Deficit/Hyperactivity Disorders | JAMA | JAMA Network
[Skip to Navigation]
Sign In
Views 5,136
Citations 0
News From the Food and Drug Administration
May 3, 2022

First Amphetamine Transdermal Patch Approved for ADHD

JAMA. 2022;327(17):1642. doi:10.1001/jama.2022.5727

The FDA has approved the first amphetamine transdermal patch for treating attention-deficit/hyperactivity disorder (ADHD) among adults and children aged 6 years or older.

Corium Inc

The dextroamphetamine patch, marketed as Xelstrym, is applied for up to 9 hours, takes effect after 2 hours, and remains effective for up to 12 hours. It is designed to give clinicians and patients more control over dosing time to better fit their schedules and optimize treatment benefits, according to a statement by manufacturer Noven Pharmaceuticals, Inc. The new patch is the second transdermal treatment for ADHD; the FDA approved a methylphenidate stimulant patch marketed as Daytrana in 2006 containing the same active ingredient as Ritalin.

In a phase 2 study of 110 patients aged 6 to 17 years, those treated with the dextroamphetamine patch met the primary end point of significant improvement compared with placebo-treated controls on a standardized rating of classroom impairment due to ADHD. It also met secondary end points for time from dosing to onset of effect and for performance on a test measuring ability to attend and initiate tasks.

The most common adverse effects observed among children were decreased appetite, headache, insomnia, tic, abdominal pain, vomiting, nausea, irritability, blood pressure increase, and heart rate increase. The patch’s efficacy and safety for adults were established based on a comparable pharmacokinetic profile in adults and children and studies showing similarity to oral lisdexamfetamine, a stimulant marketed as Vyvance.

Noven is preparing the patch’s commercial launch for the second half of 2022. It will be available in 4 strengths ranging from 4.5 mg to 18 mg, according to the company.

×