Xelstrym to Launch Soon: New FDA-Approved ADHD Stimulant Patch
Xelstrym is the first FDA-approved transdermal amphetamine patch to treat pediatric and adult patients with ADHD. It is expected to launch later this year.
May 1, 2023
A new stimulant medication, Xelstrym (dextroamphetamine), will soon be available for the treatment of attention deficit hyperactivity disorder (ADHD) in children ages 6-17 and adults 18 and older. Xelstrym is the only transdermal amphetamine patch to be approved by the Food and Drug Administration (FDA). It was presented at the annual conference of the American Professional Society of ADHD and Related Disorders (APSARD) by drug manufacturer Noven Pharmaceuticals, Inc., in January.
Xelstrym is a once-daily patch that should be administered two hours before an effect is needed and removed after nine hours. It has a printed backing on one side and a release liner on the other. Medication is absorbed through the skin via application to the hip, upper arm, chest, upper back, or flank areas.
According to a Noven press release distributed on January 10, Xelstrym would be available by the end of March. It is now expected to launch later this year.
Xelstrym is available in the following strengths: 4.5mg, 9mg, 13.5mg, and 18mg. Patients with a known sensitivity to amphetamine products should avoid taking Xelstrym. 1, 2
The FDA approved Xelstrym in March 2022, one year after approving the stimulant Azstarys for the treatment of ADHD in people ages 6 and older.
Dextroamphetamine is approved for the treatment of narcolepsy and ADHD. U.S. brand names for dextroamphetamine, besides Xelstrym, include:
Adderall Shortage: Could Xelstrym Help Patients?
Xelstrym may help lessen the impact of the lingering Adderall shortage — which began last November and has affected the supplies of other well-known stimulants — however it is also a Schedule II medication subject to regulations by the U.S. Drug Enforcement Administration (DEA). After a $21 billion nationwide opioid settlement, new limits were imposed on controlled drug supplies by the DEA. ADHD stimulant medications are classified as federally controlled substances (CII).
In a recent ADDitude reader panel, patients described the hardships they’ve faced since the shortage began. Ann from Illinois, like many women with ADHD, went undiagnosed for much of her life. She was diagnosed in October 2021 but has struggled to fill her prescription since then.
“All my life, I beat myself up mentally because I thought I was lazy and worthless, but knowing I had ADHD and needed support from medication made me see myself in a new light,” she said.
“It was heartbreaking for me when the Adderall shortage hit my local area. It felt like this new healing journey was cut abruptly when I could no longer find my medication in stock anywhere. I became depressed as I fell back into old habits where I laid around screaming at myself in my mind to get up and do something, anything! Thankfully, my pharmacist worked with me to get on Vyvanse.”
One ADDitude reader said they called seven pharmacies in one day to get their Adderall prescription filled, but instead “went two weeks without medication because there was nothing I could do.”
Tiff, who lives in Kentucky, hasn’t gotten “any dose or type of ADHD medication since late August 2022.”
“Currently, I take Bupropion twice a day. It is not helping with my ADHD at all. We couldn’t get Vyvanse paid for, so that was a no-go. This is affecting every aspect of my life, including work.”
One mom from California relayed the hardship her family experiences due to 30-day refill maximums for her child’s Class II stimulant medication.
“It is a real hardship for my child in college,” she said. “We have to work together as a family to get him his medication during this critical time of his education. And there is little empathy from our health providers. They just expect us to ‘buck up and deal with it.’”
More on Xelstrym
To learn more about Xelstrym, including usage and side effects, visit www.noven.com/xelstrym/. To receive future updates on its release, visit www.xelstrym.com.
