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Noven’s Xelstrym (dextroamphetamine) Transdermal System Receives the US FDA’s Approval for the Treatment of ADHD

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Noven’s Xelstrym (dextroamphetamine) Transdermal System Receives the US FDA’s Approval for the Treatment of ADHD

Noven’s Xelstrym (dextroamphetamine) Transdermal System Receives the US FDA’s Approval for the Treatment of ADHD

Shots:

  • The approval was based on a cross-over design, modified analog classroom study evaluating the safety and efficacy of Xelstrym vs PBO in pediatric patients aged 6 to 17yrs. with ADHD. The product is expected to be launched in the US as early as H2’22
  • The primary efficacy EPs showed a significant separation from PBO with the use of Xelstrym while efficacy and safety were based on the comparable PK profile in adults and children and established a bridge to adequate & well-controlled studies of lisdexamfetamine.
  • The product will be available in dosage strengths of 4.5mg/9hrs., 9mg/9hrs, and 13.5mg/9hrs. & 18mg/9hrs. The therapy also marks the 1st US FDA approved amphetamine transdermal patch for the same indication

Ref: Noven | Image: Noven

Click here to­ read the full press release 

Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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