Dextroamphetamine Patch Gains Approval for ADHD Treatment

March 22, 2022

Xelstrym™ (dextroamphetamine – Noven Pharmaceuticals) is now the first FDA- approved dextroamphetamine transdermal patch for attention deficit hyperactivity disorder (ADHD). It is indicated to treat ADHD in patients who are at least six years of age.

  • The active pharmaceutical ingredient of Xelstrym, dextroamphetamine, has held FDA approval since 2001 to treat ADHD. It is considered a Class II Controlled Substance.
  • Recommended dosing is as follows:
    • Pediatric patients (6-17 years old): Recommended starting dose of 4.5mg/9 hours, titrated in weekly implements of 4.5mg based on tolerability and clinical effect, up to a maximum recommended dose of 18mg/9 hours.
    • Adults (18 years and up): Recommended starting dose of 9mg/9 hours, with possible dosage adjustment up to a maximum recommended dose of 18mg/9 hours based on tolerability and clinical effect.
  • Per the prescribing information, Xelstrym patches should be applied two hours before an effect is needed and removed within nine hours of application. The product will be available in four dosage strengths: 5mg/9 hours, 9mg/9 hours, 13.5mg/9 hours, and 18mg/9 hours. It cannot be substituted for other amphetamine products on a milligram per milligram basis because of differences in amphetamine base compositions and pharmacokinetic profiles.
  • Launch and pricing information are not yet available.
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