4.6 Review

Viloxazine in the Treatment of Attention Deficit Hyperactivity Disorder

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Summary: This study aimed to compare the pharmacokinetics and safety of combination viloxazine ER and methylphenidate versus using each drug alone. The results showed that coadministration did not affect the pharmacokinetics of either drug, and the combination therapy appeared to be safe and well tolerated.

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Summary: The study aimed to translate scores from comprehensive assessments of symptom severity and functional impairment into clinically meaningful CGI levels. Post-hoc analyses showed that improvements in the CGI-I were associated with changes in ADHD-RS-5 and WFIRS-P scores, providing benchmarks for interpreting study results in a clinically relevant context for ADHD patients.

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Early response to SPN-812 (viloxazine extended-release) can predict efficacy outcome in pediatric subjects with ADHD: a machine learning post-hoc analysis of four randomized clinical trials

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Summary: Machine learning was used to determine if early response could predict efficacy outcome in pediatric patients with ADHD treated with SPN-812. Analysis showed that changes in ADHD-RS-5 Total score and CGI-I score were the best predictors, with a high positive predictive power and sensitivity when looking at changes in ADHD-RS-5 Total score at Week 2 to predict treatment response at Week 6.

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