An Open-Label Extension Study Assessing the Long-Term Safety and Efficacy of Viloxazine Extended-Release Capsules in Adults with Attention-Deficit/Hyperactivity Disorder DOI Creative Commons
Ann Childress, Andrew J. Cutler, Lenard A. Adler

и другие.

CNS Drugs, Год журнала: 2024, Номер 38(11), С. 891 - 907

Опубликована: Окт. 7, 2024

Viloxazine ER (extended-release capsules; Qelbree®) is a nonstimulant medication that has been approved by the United States Food and Drug Administration (FDA) for treatment of attention-deficit/hyperactivity disorder (ADHD) in children (> 6 years old) adults. This phase 3 open-label extension to pivotal 3, double-blind trial evaluated long-term safety continued efficacy viloxazine adults with ADHD. was multicenter, flexible-dose, III, double-blind, placebo-controlled (NCT04016779). initiated at 200 mg/day adjusted (between 600 mg/day) achieve optimal tolerability. Trial enrollment halted temporarily (24 March 2020 23 July 2020) due coronavirus disease 2019 (COVID-19) pandemic. Participants completing during time were offered delayed upon requalification. Safety outcomes primary objectives. Secondary objectives outcomes, including ADHD Investigator Symptom Rating Scale (AISRS), assessed relative baseline (or re-entry those whose COVID-19 pandemic). Overall, 159 participants (133 immediate 26 rollover) received ER, mean exposure 265 ± 254.9 days. Adverse events (AEs) included 10% incidence) insomnia (13.8%), nausea headache (10.7%), fatigue (10.1%). AEs led discontinuation 17.6% [most commonly (2.5%), (1.9%)]. AISRS total score [baseline standard deviation (SD): 37.9 6.3] improved first follow-up visit (−11.4 9.5; week 2) improvement subsequent visits (last on-study visit: −18.2 11.54). Similar patterns seen other measures efficacy, quality life executive function. Following initial dose optimization, most (73%) used doses ≥ 400 mg/day, 36% using mg/day. Long-term use well tolerated, no new findings. Improvements symptoms associated sustained throughout participation. In total, 73% percent adult this study mg or more maintenance treatment. Clinicaltrials.gov Identifier: NCT04143217. Attention-deficit/hyperactivity common characterized inattention, impulsivity, hyperactivity can substantially interfere everyday life. On basis positive results from clinical studies children, adolescents, adults, (viloxazine extended-release capsules) US approval as marketed under brand name Qelbree® (Supernus Pharmaceuticals, Inc). Adults who participated short-term (6 weeks) eventually FDA invited enroll monitor medication's efficacy. also provided pathway continue receiving until its commercial availability. dosages between on symptom response side effects (most least mg/day). demonstrated have good tolerability profile. The symptoms, life, function (executive includes cognitive skills such organizing following through tasks). further support option

Язык: Английский

Assessing acute effects of methylphenidate and modafinil on inhibitory capacity, time estimation, attentional lapses, and compulsive-like behavior in rats DOI
Rodrigo Sosa,

Pedro Espinosa–Villafranca,

Pablo Saavedra

и другие.

Behavioural Pharmacology, Год журнала: 2025, Номер unknown

Опубликована: Янв. 29, 2025

Medications known as ‘cognitive enhancers’ are increasingly being consumed off-label by healthy people, raising concerns about their safety. The aim of our study was to profile behavioral performance upon oral administration methylphenidate (2.5 mg/kg) and modafinil (64 – two popular cognitive enhancers discontinuation. We modeled cognitively demanding challenges in neurotypical individuals using a task where Wistar Lewis rats had withhold responses for specified time obtain food rewards. This allowed us extract several measures associated with clinically meaningful indices, such compulsive-like responding, incapacity wait (impulsivity), estimation (precision accuracy), attentional lapses. Our design involved examining these indices subjects administered either methylphenidate, modafinil, or vehicle. found that obtained fewer rewards were less efficient reward pursuing than the vehicle group; this result likely due drug-induced inability wait. Upon discontinuation, earned more but did not entirely catch up group. As neither favorable nor unfavorable effects main analyses. However, an exploratory analysis changes within sessions suggested fostered favorable, yet short-lived, effects. discuss results terms risks cost-benefits doses above below effective dose enhancement drugs.

Язык: Английский

Процитировано

0

Serotonin dysfunction in ADHD DOI Creative Commons

E.Amanda Jackson,

Timothy B. Riley,

Paul G. Overton

и другие.

Journal of Neurodevelopmental Disorders, Год журнала: 2025, Номер 17(1)

Опубликована: Апрель 22, 2025

Abstract It is well accepted that attention deficit hyperactivity disorder (ADHD) in part driven by dysfunction the monoaminergic neurotransmitter system, but both extent of and possible therapeutic avenues presented serotonergic neurotransmission frequently overlooked. As such, we present key evidence for transmission, as seen from biochemical, genetic pharmacological perspectives. An overall serotonin availability a common theme throughout literature, thus this review aims to explore dysfunctions synthesis pathway which result reduced bioavailability, investigate whether such could be loci change ADHD. We have identified several steps namely conversion tryptophan 5-hydroxytryptophan its use cofactor tetrahydrobiopterin, promising development novel clinical interventions

Язык: Английский

Процитировано

0

Viloxazine extended-release capsules as an emerging treatment for attention-deficit/hyperactivity disorder in children and adolescents DOI Creative Commons

Vladimir Maletic,

Gregory W. Mattingly,

Jami Earnest

и другие.

Expert Review of Neurotherapeutics, Год журнала: 2024, Номер 24(5), С. 443 - 455

Опубликована: Март 19, 2024

Introduction Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental characterized by inattention and/or hyperactivity and impulsivity. Viloxazine extended-release (ER) capsules (Qelbree®) US Food Drug Administration–approved nonstimulant treatment option for children, adolescents, adults with ADHD.

Язык: Английский

Процитировано

1

An Open-Label Extension Study Assessing the Long-Term Safety and Efficacy of Viloxazine Extended-Release Capsules in Adults with Attention-Deficit/Hyperactivity Disorder DOI Creative Commons
Ann Childress, Andrew J. Cutler, Lenard A. Adler

и другие.

CNS Drugs, Год журнала: 2024, Номер 38(11), С. 891 - 907

Опубликована: Окт. 7, 2024

Viloxazine ER (extended-release capsules; Qelbree®) is a nonstimulant medication that has been approved by the United States Food and Drug Administration (FDA) for treatment of attention-deficit/hyperactivity disorder (ADHD) in children (> 6 years old) adults. This phase 3 open-label extension to pivotal 3, double-blind trial evaluated long-term safety continued efficacy viloxazine adults with ADHD. was multicenter, flexible-dose, III, double-blind, placebo-controlled (NCT04016779). initiated at 200 mg/day adjusted (between 600 mg/day) achieve optimal tolerability. Trial enrollment halted temporarily (24 March 2020 23 July 2020) due coronavirus disease 2019 (COVID-19) pandemic. Participants completing during time were offered delayed upon requalification. Safety outcomes primary objectives. Secondary objectives outcomes, including ADHD Investigator Symptom Rating Scale (AISRS), assessed relative baseline (or re-entry those whose COVID-19 pandemic). Overall, 159 participants (133 immediate 26 rollover) received ER, mean exposure 265 ± 254.9 days. Adverse events (AEs) included 10% incidence) insomnia (13.8%), nausea headache (10.7%), fatigue (10.1%). AEs led discontinuation 17.6% [most commonly (2.5%), (1.9%)]. AISRS total score [baseline standard deviation (SD): 37.9 6.3] improved first follow-up visit (−11.4 9.5; week 2) improvement subsequent visits (last on-study visit: −18.2 11.54). Similar patterns seen other measures efficacy, quality life executive function. Following initial dose optimization, most (73%) used doses ≥ 400 mg/day, 36% using mg/day. Long-term use well tolerated, no new findings. Improvements symptoms associated sustained throughout participation. In total, 73% percent adult this study mg or more maintenance treatment. Clinicaltrials.gov Identifier: NCT04143217. Attention-deficit/hyperactivity common characterized inattention, impulsivity, hyperactivity can substantially interfere everyday life. On basis positive results from clinical studies children, adolescents, adults, (viloxazine extended-release capsules) US approval as marketed under brand name Qelbree® (Supernus Pharmaceuticals, Inc). Adults who participated short-term (6 weeks) eventually FDA invited enroll monitor medication's efficacy. also provided pathway continue receiving until its commercial availability. dosages between on symptom response side effects (most least mg/day). demonstrated have good tolerability profile. The symptoms, life, function (executive includes cognitive skills such organizing following through tasks). further support option

Язык: Английский

Процитировано

0