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New Treatment Option for Attention Deficit Hyperactivity Disorders (ADHD) Approved in the USA

Strategic Insights

— 1 min read

A recent study published in the journal CNS Drugs has reported on the approval of an extended-release once-daily oral capsule formulation of viloxazine (viloxazine ER) for the treatment of Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients and adults. The research highlights the efficacy and safety profile of viloxazine ER in reducing symptoms and severity of ADHD in adults, as well as its potential as a valuable addition to existing therapeutic options. The study found that improvements in executive function and reduction in ADHD symptoms were observed within 2-3 weeks and were sustained with continued treatment for over 24 months.

Key Takeaways:

  • Viloxazine ER, a norepinephrine reuptake inhibitor and serotonin receptor modulator, has been approved in the USA for the treatment of ADHD in pediatric patients and adults.
  • A 6-week phase 3 trial demonstrated the efficacy of viloxazine ER in reducing ADHD symptoms and severity in adults, with improvements observed within 2-3 weeks.
  • The most common adverse reactions reported with viloxazine ER were insomnia and headache, with an acceptable safety profile and no clinically significant cardiovascular or hepatic adverse effects.
  • The study concluded that current evidence supports viloxazine ER as a valuable addition to existing therapeutic options for adults with ADHD.
  • The research was published in the journal CNS Drugs and was peer-reviewed.

Statistics:

  • The study found that improvements in executive function and reduction in ADHD symptoms were observed within 2-3 weeks.
  • Continued treatment for over 24 months sustained the improvements in ADHD symptoms and executive function.
  • The most common adverse reactions reported with viloxazine ER were insomnia (12.5%) and headache (10.4%).

Sources:

  • CNS Drugs, 2025, "Viloxazine Extended-Release: A Review in Attention-Deficit/Hyperactivity Disorder in Adults"
  • NewsRx, November 3, 2025, "New Attention Deficit Hyperactivity Disorders Study Findings Have Been Reported by Yahiya Y. Syed and Colleagues (Viloxazine Extended-Release: A Review in Attention-Deficit/Hyperactivity Disorder in Adults)"

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