A Phase 3, Placebo-Controlled Trial of Once-Daily Viloxazine Extended-Release Capsules in Adolescents With Attention-Deficit/Hyperactivity Disorder

• Published in: Journal of clinical psychopharmacology Vol. 41; no. 4; p. 370
• Main Authors: Nasser, Azmi, Liranso, Tesfaye, Adewole, Toyin, Fry, Nicholas, Hull, Joseph T, Busse, Gregory D, Chowdhry, Fatima, Cutler, Andrew J, Jones, Nandita Joshi, Findling, Robert L, Schwabe, Stefan
• Format: Journal Article
• Language: English
• Published: United States 01.07.2021
• Subjects: Adolescent; Adolescent Behavior - drug effects; Adolescent Behavior - psychology; Adrenergic Uptake Inhibitors - administration & dosage; Adrenergic Uptake Inhibitors - adverse effects; Attention Deficit Disorder with Hyperactivity - diagnosis; Attention Deficit Disorder with Hyperactivity - drug therapy; Attention Deficit Disorder with Hyperactivity - psychology; Behavioral Symptoms - diagnosis; Delayed-Action Preparations - administration & dosage; Delayed-Action Preparations - adverse effects; Dose-Response Relationship, Drug; Double-Blind Method; Drug Monitoring - methods; Female; Humans; Male; Psychiatric Status Rating Scales; Symptom Assessment - methods; Treatment Outcome; Viloxazine - administration & dosage; Viloxazine - adverse effects
• ISSN: 1533-712X
• DOI: 10.1097/JCP.0000000000001404

This phase 3 clinical trial evaluated the efficacy and safety of viloxazine extended-release capsules (VLX-ER) as a monotherapy for attention-deficit/hyperactivity disorder (ADHD) in adolescents (12-17 years). Eligible subjects (n = 310) were randomized to receive once-daily 200 and 400 mg VLX-ER, or placebo for 6 weeks. The primary efficacy end point was change from baseline (CFB) at the end of study (EOS) in ADHD Rating Scale-5 Total score. Key secondary end points were Clinical Global Impression-Improvement score at EOS, CFB at EOS in Conners 3-Parent Short Form Composite T-score, and CFB at EOS in Weiss Functional Impairment Rating Scale-Parent Total average score. In the 200-mg/d and 400-mg/d VLX-ER treatment groups, a significant improvement was found in the CFB at EOS in ADHD Rating Scale-5 Total (P = 0.0232, P = 0.0091) and Inattention (P = 0.0424, P = 0.0390) and Hyperactivity/Impulsivity (P = 0.0069, P = 0.0005) subscale scores versus placebo. The Clinical Global Impression-Improvement score was significantly improved at EOS in the 200-mg/d and 400-mg/d VLX-ER groups versus placebo (P = 0.0042, P = 0.0003). The Conners 3-Parent Short Form composite T-score and Weiss Functional Impairment Rating Scale-Parent Total average score exhibited improvement in both VLX-ER groups; however, the difference versus placebo was not statistically significant. The most common treatment-related adverse events were somnolence, headache, decreased appetite, nausea, and fatigue. The adverse event-related discontinuation rates were <5% in all groups. Viloxazine extended-release demonstrated statistically significant and clinically meaningful improvement in ADHD symptoms in adolescents and was generally well tolerated.