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

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

Real world pharmacovigilance comparison of viloxazine and dextroamphetamine adverse reaction profiles. (PubMed, Sci Rep) - "Although the study benefits from database utilization, its limitation lies in the spontaneous reporting system. Accurate drug safety evaluation requires future enhancements."

Adverse events • Clinical • Journal • Real-world evidence • Retrospective data • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Depression • Mental Retardation • Mood Disorders • Psychiatry

Supernus Announces Paragraph IV ANDA Filings for Qelbree (The Manila Times) - "Supernus Pharmaceuticals, Inc...announced that the Company received Paragraph IV Notice Letters from third parties notifying Supernus that the third parties submitted Abbreviated New Drug Applications (ANDAs) for viloxazine extended-release capsules, eq. 100, 150, and 200 mg base. Supernus is currently reviewing the details of these Notice Letters and intends to vigorously enforce its intellectual property rights relating to Qelbree. The U.S. Food and Drug Administration's Orange Book currently lists six issued United States patents as covering Qelbree, three that expire in September 2029, two that expire in February 2033 and one that expires in April 2035."

ANDA • CNS Disorders

Viloxazine ER for Adults With Attention-Deficit/Hyperactivity Disorder and Mood Symptoms: Results of a Decentralized Open-Label Phase IV Trial (APA 2025) - P4 | "Viloxazine ER (extended-release capsules; Qelbree®) is an FDA-approved medication for pediatric and adult ADHD, an immediate-release formulation was previously available as a treatment for depression and anxiety for over 30-years in Europe... Adults treated with viloxazine ER alone or added to existing treatments, experienced improvement in ADHD, depression, and anxiety symptoms with acceptable safety and tolerability. Results are consistent with viloxazine's unique multimodal pharmacology and history of use as an antidepressant."

Clinical • P4 data • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Constipation • Depression • Fatigue • Gastroenterology • Gastrointestinal Disorder • Insomnia • Migraine • Mood Disorders • Pain • Pediatrics • Psychiatry • Sleep Disorder • Xerostomia

Efficacy and Tolerability of Viloxazine Compared to Placebo on Emotional, Behavioral, and Executive Functioning in Children and Adolescents with ADHD: A Systematic Review and Meta-Analysis. (PubMed, Neuropsychiatr Dis Treat) - "Further research is essential to explore the long-term safety and efficacy of viloxazine, particularly in adolescents, and to more completely understand the mechanisms of its action. Future studies should also compare viloxazine with other non-stimulant treatments to optimize ADHD management strategies."

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

Analysis of risk signals for Viloxazine in the treatment of attention deficit hyperactivity disorder based on the FAERS database. (PubMed, J Affect Disord) - "Viloxazine has shown efficacy and tolerability but poses potential safety risks, particularly regarding mood, behavior, and sensory processing. Ongoing monitoring and further studies are needed."

Journal • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • Behavior Disorders • CNS Disorders • Dystonia • Gastroenterology • Gastrointestinal Disorder • Mental Retardation • Mood Disorders • Movement Disorders • Pain • Psychiatry • Suicidal Ideation

Comparative cardiovascular safety of medications for attention-deficit hyperactivity disorder in children, adolescents, and adults: a systematic review and network meta-analysis. (PubMed, Lancet Psychiatry) - "Practitioners should monitor blood pressure and pulse in patients with ADHD treated with any pharmacological intervention, and not stimulants only. Given the short duration of available randomised controlled trials, new research providing insights on the causal effects of ADHD medications on cardiovascular parameters in the longer term should be funded."

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

Viloxazine Extended-Release Administered With Psychostimulants in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder: A Phase 4, Open-Label Trial. (PubMed, J Child Adolesc Psychopharmacol) - " Combined treatment with VLX-ER and psychostimulant therapy showed acceptable safety and tolerability, with improvement in morning and evening ADHD behaviors and sleep disturbances relative to stimulant monotherapy. Timing of VLX-ER administration (morning or evening) did not appear to affect safety, drug response, or sleep improvement."

Journal • P4 data • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Infectious Disease • Pain • Pediatrics • Psychiatry • Respiratory Diseases • Sleep Disorder

Supernus Announces Label Update for Non-Stimulant ADHD Treatment, Qelbree, Including New Pharmacodynamic Data and Information for Breastfeeding Women (GlobeNewswire) - "Supernus Pharmaceuticals, Inc...announced that the U.S. Food and Drug Administration (FDA) has approved an update for the label for Qelbree (viloxazine extended-release capsules) to include new pharmacodynamic data in Section 12.2. The updated label describes viloxazine’s partial agonist activity at the serotonin 5-HT2C receptor and inhibition of the norepinephrine transporter, reinforcing its multimodal pharmacodynamic profile. The mechanism of action of Qelbree, though unclear, is thought to be through inhibiting the reuptake of norepinephrine. Additionally, the updated label now includes new lactation data for breastfeeding women with attention-deficit/hyperactivity disorder (ADHD), showing that the transfer of Qelbree into breastmilk is low. Qelbree is approved for use in patients ages 6 years and older with ADHD."

FDA event • Attention Deficit Hyperactivity Disorder • CNS Disorders

Nonstimulant Medications for Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents. (PubMed, Pediatr Ann) - "The recommended nonstimulant ADHD medications include alpha agonists (eg, guanfacine extended-release [ER], clonidine ER) and norepinephrine reuptake inhibitors (eg, atomoxetine, viloxazine)...[Pediatr Ann. 2025;54(1):e27-e33.]."

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

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

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

Response Trajectories and Temporal Trends of Viloxazine Treatment for Young People With ADHD: A Meta-Analysis. (PubMed, JAMA Netw Open) - "Future studies are warranted to assess the long-term effect of viloxazine. Viloxazine was relatively well tolerated for children and adolescents with ADHD."

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

Pharmacological Strategies in ADHD: Focus on Pragmatic Management (AACAP 2024) - "Data on adverse effects and combination therapies were also reviewed. The literature combined with the clinical experience indicates that alterations in the use of traditional stimulants in existing and novel release forms, atomoxetine, viloxazine, alpha agonists, the use of alternative agents, and combinations of medications, can enhance a patient's ADHD response. Pharmacological strategies will be reported for those who: 1) have not responded to traditional agents; 2) manifest side effects; and 3) present with comorbidity(ies). Both empirically derived data and illustrative cases will be used in this pragmatic presentation.PPC, ADHD, PKS"

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

An Open-Label Extension Study Assessing the Long-Term Safety and Efficacy of Viloxazine Extended-Release Capsules in Adults with Attention-Deficit/Hyperactivity Disorder. (PubMed, CNS Drugs) - P3 | "Long-term viloxazine ER use was well tolerated, with no new long-term safety findings. Improvements in ADHD symptoms and associated measures were sustained throughout trial participation. In total, 73% percent of adult participants in this long-term study used viloxazine ER doses of 400 mg or more during maintenance treatment."

Journal • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Fatigue • Infectious Disease • Insomnia • Novel Coronavirus Disease • Pain • Psychiatry • Respiratory Diseases • Sleep Disorder

Attention-Deficit/Hyperactivity Disorder in Adults. (PubMed, Am Fam Physician) - "Clinical guidelines recommend a subset of amphetamine and methylphenidate stimulants as first-line pharmacotherapy, which may be more effective when combined with psychotherapy. For adults unable to take stimulants or with concurrent anxiety/depression, options include atomoxetine, viloxazine, and bupropion. To monitor for patient misuse or diversion of stimulants, physicians should consider employing controlled substance agreements and prescription drug monitoring programs."

Journal • Review • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Depression • Developmental Disorders • Mental Retardation • Mood Disorders • Psychiatry

Quantification of ADHD medication in biological fluids of pregnant and breastfeeding women with liquid chromatography: a comprehensive review. (PubMed, Front Public Health) - "This review aims (1) to compile and critically assess existing research on the transfer of ADHD medications into breast milk and the potential implications for nursing infants and (2) to provide a comprehensive overview and discussion of the literature regarding the quantification of methylphenidate, amphetamine, atomoxetine, viloxazine, guanfacine, clonidine and bupropion in the blood, urine, oral fluid, and breast milk with liquid chromatography...We illustrate the lack of methods to simultaneously monitor multiple ADHD medications as well as the lack of developed methods for breast milk. Finally, we highlight the need for continued research to refine our understanding of medication transfer into breast milk and potential risks, and to develop clinical guidelines to support mothers with ADHD in making informed choices regarding medication use during pregnancy and lactation."

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

Treatment Preferences of Adult Patients with Attention-Deficit/Hyperactivity Disorder - A Discrete Choice Experiment. (PubMed, Patient Prefer Adherence) - "Overall preferences for treatment profiles approximating centanafadine, lisdexamfetamine, atomoxetine, and viloxazine were estimated using adjusted total utilities...Accordingly, a profile resembling that of centanafadine would be preferred by an average patient compared to key competitors due to its favorable safety profile. These findings may help improve treatment decision-making, enhance treatment satisfaction, and foster adherence."

Journal • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Insomnia • Mood Disorders • Psychiatry • Sleep Disorder • Xerostomia

Open-label Study to Evaluate Long-term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) (clinicaltrials.gov) - P3 | N=1400 | Active, not recruiting | Sponsor: Supernus Pharmaceuticals, Inc. | Trial completion date: Jun 2025 ➔ Sep 2026 | Trial primary completion date: Jun 2025 ➔ Sep 2026

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