Qelbree (viloxazine extended-release capsules) / Supernus Pharma, Knight Therap - LARVOL DELTA

Age-stratified safety signal mining of ADHD medications in pediatric populations using the FAERS database (2014-2024): a pharmacovigilance study using multi-method disproportionality analysis. (PubMed, Front Pediatr) - "α2-agonists accounted for 79/100 (clonidine-ER 52, guanfacine-ER 27)...Methylphenidate showed no Strong signals under within-class or full-pediatric comparators. Distinct age-specific safety signals emerged for ADHD medications, with dextroamphetamine-PRES warranting targeted pharmacovigilance attention."

Adverse events • Journal • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Pediatrics • Psychiatry

Prescription Stimulant Therapy and Risk of Constipation in Adults With ADHD: A Propensity-Matched Multicenter Cohort Study (ACG 2026) - "The stimulant cohort included patients receiving amphetamine or amphetamine-like stimulants, excluding prior stimulant exposure and non-stimulant ADHD medication exposure. The non-stimulant cohort included patients receiving atomoxetine, guanfacine, clonidine, or viloxazine, excluding prior non-stimulant exposure and stimulant exposure... After matching, 36,501 patients were included in each cohort. At 1 year, constipation occurred in 617/33,224 stimulant users versus 832/32,541 non-stimulant users (1.9% vs 2.6%; RR 0.726, 95% CI 0.655â0.805; p< 0.001). Stimulant therapy was also associated with lower laxative/constipation medication use (5.3% vs 5.8%; RR 0.916, 95% CI 0.857â0.980; p=0.011) and ileus risk (0.04% vs 0.10%; RR 0.371, 95% CI 0.196â0.701; p=0.001)."

Clinical • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Psychiatry

Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD (clinicaltrials.gov) - P4 | N=286 | Recruiting | Sponsor: Supernus Pharmaceuticals, Inc. | Trial completion date: Jun 2026 ➔ Jan 2028 | Trial primary completion date: Jun 2026 ➔ Jan 2028

Trial completion date • Trial primary completion date • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Updates in treatment strategies in ADHD (WFSBP 2026) - "Lisdexamfetamine, a prodrug cleaved gradually by red blood cell enzymes, provides smoother pharmacokinetics and lower abuse potential due to slower peak concentrations...OROS-methylphenidate mimics twice-daily dosing through osmotic release, while transdermal methylphenidate bypasses first-pass metabolism and reduces appetite suppression. Serdexmethylphenidate and ion-exchange amphetamine preparations further improve duration and plasma stability...These mechanisms may improve emotional dysregulation and provide faster onset than atomoxetine...Investigational therapies include centanafadine, a triple DAT-NET-SERT inhibitor targeting emotional dysregulation; TAAR-1 agonists, which modulate dopamine and glutamate signaling; and metadoxine extended release, which restores GABA-glutamate balance and may preferentially benefit inattentive ADHD...DAT1 and SERT polymorphisms may predict stimulant or serotonergic treatment response, while COMT Val158Met variants influence..."

ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Mood Disorders • Psychiatry • Tic Disorders • Tourette Syndrome • COMT

Effect of Hepatic Impairment on the Pharmacokinetics of Single-Dose Viloxazine Extended-Release Capsules (Qelbree®) in Adults. (PubMed, Clin Drug Investig) - "Mild-to-severe HI showed minimal impact on viloxazine ER exposure. The single dose of viloxazine ER was well-tolerated with no identified safety concerns."

Clinical • Journal • PK/PD data • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Hepatology • Pain • Pediatrics • Psychiatry

Utility of ADHD Medications in Children and Adolescents with Trauma-Related Presentations: A Systematic Scoping Review. (PubMed, J Child Adolesc Psychopharmacol) - "Stimulants have been shown to benefit wider long-term psychiatric outcomes, although smaller studies demonstrated a more consistent improvement in specific trauma-related symptoms with alpha-2 agonists. Rather than following a rigid medication sequence, clinicians should adopt a trauma-informed approach that prioritizes or combines treatments based on whether ADHD or trauma is the primary driver of functional impairment. However, because the current evidence is predominantly low quality and lacks controlled trials, these findings must be interpreted with caution."

Journal • Review • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Mood Disorders • Pediatrics • Post-traumatic Stress Disorder • Psychiatry

AK-D101_BS: A Phase 3 Study of Viloxazine ER Capsules in Korean Children and Adolescents With ADHD (clinicaltrials.gov) - P3 | N=156 | Not yet recruiting | Sponsor: Alvogen Korea

New P3 trial • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Viloxazine occupies the 5-HT2C receptor in the macaca fascicularis brain in vivo: A [11C]CIMBI-36 positron emission tomography study. (PubMed, Int J Neuropsychopharmacol) - "Efficacy of viloxazine ER (extended-release capsules; Qelbree®) for attention-deficit/hyperactivity disorder (ADHD) is attributed to its ability to increase extracellular norepinephrine and dopamine in the medial prefrontal cortex by inhibiting norepinephrine transporters (NET); however, studies also suggest potentially relevant activity at serotonin (5-HT) receptors...At these clinically relevant concentrations, receptor occupancy calculations (based on [11C]CIMBI-36 displacement) suggested relevant viloxazine occupancy at 5-HT2C (66.0-97.5%). Overall, results demonstrate that (in addition to NET inhibition) viloxazine acts on 5-HT2C receptors at concentrations clinically relevant for ADHD treatment, and these effects could therefore contribute to therapeutic activity."

Journal • Preclinical • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Viloxazine Extended Release in Adults With Attention-Deficit/Hyperactivity Disorder and Depression and/or Anxiety Symptoms: Results From a Decentralized, Open-Label, Phase 4 Trial. (PubMed, J Clin Psychiatry) - P4 | " Viloxazine ER was well tolerated and associated with improvements in ADHD, depression, and anxiety symptoms in this real-world study of adults with ADHD and comorbid symptoms. Trial Registration: ClinicalTrials.gov identifier: NCT06185985."

Journal • P4 data • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Depression • Mood Disorders • Psychiatry

COST OF ADVERSE EVENT MANAGEMENT IN CHILDREN, ADOLESCENTS, AND ADULTS WITH ATTENTION-DEFICIT/HYPERACTIVITY DISORDER IN THE UNITED STATES (ISPOR 2026) - "Pairwise comparisons were conducted between centanafadine and each of lisdexamfetamine dimesylate, atomoxetine hydrochloride, viloxazine, methylphenidate hydrochloride, and guanfacine in children and adolescents, and each of lisdexamfetamine dimesylate, atomoxetine hydrochloride, viloxazine, and methylphenidate hydrochloride in adults. Centanafadine has the potential to reduce AE-related healthcare costs compared with alternative ADHD therapies for children, adolescents, and adults."

Adverse events • Clinical • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Efficacy and Tolerability of Viloxazine Extended-Release for Attention-Deficit/Hyperactivity Disorder in Adolescents and Adults: A Systematic Review With Qualitative Synthesis of All Studies and Meta-Analysis of Adolescent Data. (PubMed, Cureus) - "The findings overall support viloxazine ER as an effective non-stimulant pharmacotherapy option for adolescents with ADHD, particularly so when stimulant therapy is not tolerated. Further research should prioritize long-term outcomes and efficacy in adult populations."

Journal • Retrospective data • Review • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Mental Retardation • Pediatrics • Psychiatry

The Viloxazine Paradox: A Noradrenergic Agent's Journey From Antidepressant Obscurity to ADHD Precision Therapy. (PubMed, CNS Neurosci Ther) - "Viloxazine expands the range of non-stimulant treatment options for ADHD and represents a successful example of drug repurposing in neuropsychiatry. Current evidence supports its efficacy and acceptable tolerability across the lifespan, particularly for patients who do not tolerate or respond adequately to stimulants. Nevertheless, evidence for its use beyond ADHD remains limited, and future studies should focus on head-to-head comparisons with other ADHD therapies, long-term safety and efficacy, predictors of response, and potential off-label psychiatric applications."

Journal • Review • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Insomnia • Pain • Pediatrics • Psychiatry • Sleep Disorder • CYP1A2

Updated Viloxazine Pharmacology: Experiments Establish Norepinephrine Transporter Occupancy and Serotonin 5-HT2C, 5-HT2B, and 5-HT7 Receptor Binding at Therapeutically Relevant Concentrations. (PubMed, Drugs R D) - "These results validate previous experiments showing that viloxazine, in addition to displaying high NET occupancy, acts as a partial agonist at 5-HT2C receptors and an antagonist at 5-HT2B and 5-HT7 receptors at clinically relevant concentrations for ADHD treatment. Therefore, both NET inhibition and serotonin receptor activity may contribute to viloxazine's clinical efficacy. These findings are contributing to a renewed understanding of viloxazine's pharmacodynamic profile and likely multimodal mechanism of action."

Journal • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Depression • Psychiatry

Comparative Effectiveness of Pharmacological and Non-pharmacological Therapies for ADHD: A Systematic Review and Meta-analysis of Randomized Controlled Trials (2008-2023). (PubMed, Rev Recent Clin Trials) - "A comprehensive, individualized treatment plan that may combine pharmacological and non-pharmacological approaches often yields the best outcomes in managing ADHD."

HEOR • Journal • Retrospective data • ADHD (Impulsive Aggression) • Anorexia • Attention Deficit Hyperactivity Disorder • Cardiovascular • CNS Disorders • Insomnia • Psychiatry • Sleep Disorder

Open-label Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD and Mood Symptoms (clinicaltrials.gov) - P4 | N=161 | Completed | Sponsor: Supernus Pharmaceuticals, Inc. | Active, not recruiting ➔ Completed | N=750 ➔ 161

Enrollment change • Trial completion • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Connecting the dots and finding the way forward: Pharmacological, neuromodulatory, and psychotherapeutic interventions for the complex treatment of adult ADHD. (PubMed, Pharmacol Ther) - "Treatment emphasizes multimodal approaches, with stimulants as first-line pharmacotherapy due to their superior efficacy over non-stimulants like atomoxetine and viloxazine. Novel agents in development, such as centanafadine triple reuptake inhibitor and solriamfetol target core symptoms and comorbidities, showing promising phase III results...Psychotherapeutic options, particularly cognitive-behavioral therapy (CBT)-based interventions, improve symptom management and emotional regulation, often as adjuncts to medication. The review highlights the need for personalized strategies addressing adherence, comorbidity, and long-term outcomes, emphasizing integrated care to mitigate ADHD's lifelong impact."

Journal • Review • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Cognitive Disorders • Mood Disorders • Psychiatry

Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD (clinicaltrials.gov) - P4 | N=286 | Recruiting | Sponsor: Supernus Pharmaceuticals, Inc. | Trial completion date: Dec 2025 ➔ Jun 2026 | Trial primary completion date: Dec 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Benefits and harms of ADHD interventions: umbrella review and platform for shared decision making. (PubMed, BMJ) - "This review provides updated evidence to inform patients, practitioners, and guideline developers how best to manage ADHD symptoms. The online platform should facilitate the implementation of shared decision making in daily practice."

Journal • Review • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Revisiting the Role of Serotonin in ADHD (AACAP 2025) - "In addition, several medications that positively impact ADHD symptoms (eg, amphetamine, viloxazine, and monoamine oxidase [MAO] inhibitors) are associated with enhanced serotonergic activity...Of note, human fMRI studies indicate that fluoxetine challenge produces changes in activation within the prefrontal cortex similar to what is seen with ADHD medications (Chantiluike et al, 2015). We conclude that 5-HT has an important role in key associated features of ADHD and indirectly contributes to the regulation of core features of the disorder. Implications for treatment will be discussed."

ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Depression • Psychiatry

Optimizing ADHD Medication Management: From Stimulants to Nonstimulants in Children and Adolescents (AACAP 2025) - "Specifically, the presentation will cover dosing regimens, side effects, and monitoring considerations for CNS stimulants (eg, methylphenidate, amphetamine salts), alpha-2 adrenergic agonists (eg, guanfacine, clonidine), and NRIs (eg, atomoxetine, viloxazine). CNS stimulants remain the first-line treatment for ADHD, with a 70%-80% response rate in children... Effective ADHD management requires a personalized approach, balancing medication efficacy with tolerability. Clinicians must closely monitor side effects and ensure that treatment aligns with the patient's developmental stage, comorbidities, and individual needs. Continued collaboration with families and frequent follow-up are critical to optimizing long-term outcomes for children and adolescents with ADHD.ADHD, PPC, TREAT"

Clinical • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry • Suicidal Ideation

Viloxazine Extended-Release: A Review in Attention-Deficit/Hyperactivity Disorder in Adults. (PubMed, CNS Drugs) - "An extended-release once-daily oral capsule formulation of viloxazine (viloxazine ER; Qelbree®), a norepinephrine reuptake inhibitor and serotonin receptor modulator, has been approved in the USA for the treatment of attention-deficit/hyperactivity disorder (ADHD) in paediatric patients and adults...It has an acceptable safety profile, with no clinically significant cardiovascular or hepatic adverse effects. Current evidence supports viloxazine ER as a valuable addition to the therapeutic options available for adults with ADHD."

Clinical • Journal • Review • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • Cardiovascular • CNS Disorders • Insomnia • Pain • Pediatrics • Psychiatry • Sleep Disorder

Potential treatments for attention-deficit/Hyperactivity disorder: a focus on phase III trials. (PubMed, Expert Opin Pharmacother) - "Stimulant medications, such as methylphenidate and amphetamine derivatives, and non-stimulant medications, such as atomoxetine, guanfacine, clonidine, and viloxazine, are considered the cornerstones of pharmacological treatment for attention-deficit/hyperactivity disorder (ADHD)...We highlight four promising candidates: centanafadine, solriamfetol, CTx-1301, and NRCT-101SR...Additionally, multi-phase extended-release formulations may improve adherence and enhance symptom control throughout the day. As phase III data become available, these agents have the potential to redefine ADHD treatment paradigms."

Journal • P3 data • Review • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Cognitive Impairment in Adult Attention Deficit Hyperactivity Disorder: Clinical Implications and Novel Treatment Strategies. (PubMed, Clin Pract) - "Other studies revealed statistically significant improvements in cognitive flexibility and response inhibition in modafinil users...This review of the literature describes the effectiveness of novel treatment strategies of adult ADHD including non-stimulant medications, behavioral therapies and neurofeedback. This highlights the need for treatment modalities that enhance cognitive outcomes and further research into long-term efficacy and safety of these novel interventions and implementing psychological treatment into medical management of adult ADHD."

Journal • Review • ADHD (Impulsive Aggression) • Alzheimer's Disease • Attention Deficit Hyperactivity Disorder • CNS Disorders • Cognitive Disorders • Pediatrics • Psychiatry

Viloxazine Extended-Release Capsules in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder: Results of a Long-Term, Phase 3, Open-Label Extension Trial. (PubMed, CNS Drugs) - P3 | "The results of this large-scale safety trial support the long-term use of viloxazine ER as a generally well-tolerated and effective treatment option for pediatric ADHD. No new safety concerns emerged, and efficacy results suggest the potential for continued improvement over that seen during double-blind treatment."

Clinical • Journal • P3 data • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Fatigue • Infectious Disease • Pain • Pediatrics • Psychiatry

Drugs for ADHD. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry