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
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