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Showing 1 to 12 of 23 entries
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The Effect of Viloxazine Extended-Release Capsules on Functional Impairments Associated with Attention-Deficit/Hyperactivity Disorder (ADHD) in Children and Adolescents in Four Phase 3 Placebo-Controlled Trials.

Neuropsychiatric disease and treatment

Nasser A, Hull JT, Liranso T, Busse GD, Melyan Z, Childress AC, A Lopez F, Rubin J.
PMID: 34113106
Neuropsychiatr Dis Treat. 2021 Jun 03;17:1751-1762. doi: 10.2147/NDT.S312011. eCollection 2021.

PURPOSE: The ADHD Rating Scale (ADHD-RS) assesses 18 symptoms of inattention and hyperactivity/impulsivity and has been used in many clinical trials to evaluate the treatment effect of drugs on ADHD. The fifth edition of this scale (ADHD-RS-5) also assesses...

Viloxazine: A new miracle drug for attention deficit hyperactivity disorder (ADHD) or just another non-stimulant?.

Asian journal of psychiatry

Hafeez S, Saquib J, Qureshi NE.
PMID: 34871970
Asian J Psychiatr. 2021 Nov 29;67:102948. doi: 10.1016/j.ajp.2021.102948. Epub 2021 Nov 29.

No abstract available.

Viloxazine in the Treatment of Attention Deficit Hyperactivity Disorder.

Frontiers in psychiatry

Edinoff AN, Akuly HA, Wagner JH, Boudreaux MA, Kaplan LA, Yusuf S, Neuchat EE, Cornett EM, Boyer AG, Kaye AM, Kaye AD.
PMID: 34975586
Front Psychiatry. 2021 Dec 17;12:789982. doi: 10.3389/fpsyt.2021.789982. eCollection 2021.

Attention deficit hyperactivity disorder (ADHD) is the most common neurodevelopmental disorder in children. Over the past twenty years, research on the disease and its characteristics and treatment options has grown exponentially. The first-line pharmacologic treatment of ADHD is stimulants,...

New Insights into the Mechanism of Action of Viloxazine: Serotonin and Norepinephrine Modulating Properties.

Journal of experimental pharmacology

Yu C, Garcia-Olivares J, Candler S, Schwabe S, Maletic V.
PMID: 32943948
J Exp Pharmacol. 2020 Aug 25;12:285-300. doi: 10.2147/JEP.S256586. eCollection 2020.

BACKGROUND: Viloxazine was historically described as a norepinephrine reuptake inhibitor (NRI). Since NRIs have previously demonstrated efficacy in attention deficit/hyperactivity disorder (ADHD), viloxazine underwent contemporary investigation in the treatment of ADHD. Its clinical and safety profile, however, was found...

Viloxazine: A new miracle drug for attention deficit hyperactivity disorder (ADHD) or just another non-stimulant?.

Asian journal of psychiatry

Hafeez S, Saquib J, Qureshi NE.
PMID: 34871970
Asian J Psychiatr. 2021 Nov 29;67:102948. doi: 10.1016/j.ajp.2021.102948. Epub 2021 Nov 29.

No abstract available.

Viloxazine in the Treatment of Attention Deficit Hyperactivity Disorder.

Frontiers in psychiatry

Edinoff AN, Akuly HA, Wagner JH, Boudreaux MA, Kaplan LA, Yusuf S, Neuchat EE, Cornett EM, Boyer AG, Kaye AM, Kaye AD.
PMID: 34975586
Front Psychiatry. 2021 Dec 17;12:789982. doi: 10.3389/fpsyt.2021.789982. eCollection 2021.

Attention deficit hyperactivity disorder (ADHD) is the most common neurodevelopmental disorder in children. Over the past twenty years, research on the disease and its characteristics and treatment options has grown exponentially. The first-line pharmacologic treatment of ADHD is stimulants,...

A post hoc analysis of the effect of viloxazine extended-release capsules on learning and school problems in children and adolescents with attention-deficit/hyperactivity disorder.

European child & adolescent psychiatry

Faraone SV, Gomeni R, Hull JT, Busse GD, Melyan Z, Rubin J, Nasser A.
PMID: 34581911
Eur Child Adolesc Psychiatry. 2021 Sep 28; doi: 10.1007/s00787-021-01877-5. Epub 2021 Sep 28.

Improvement in attention-deficit/hyperactivity disorder (ADHD) symptoms vs. placebo was reported in a series of pediatric clinical trials of viloxazine extended-release capsules (viloxazine ER; Qelbree™). This post hoc analysis of those studies evaluated the effect of viloxazine ER on learning...

Population Pharmacokinetics of Viloxazine Extended-Release Capsules in Pediatric Subjects With Attention Deficit/Hyperactivity Disorder.

Journal of clinical pharmacology

Nasser A, Gomeni R, Wang Z, Kosheleff AR, Xie L, Adeojo LW, Schwabe S.
PMID: 34269426
J Clin Pharmacol. 2021 Dec;61(12):1626-1637. doi: 10.1002/jcph.1940. Epub 2021 Aug 08.

Viloxazine extended-release capsules (viloxazine ER; Qelbree) is a novel nonstimulant, recently approved by the US Food and Drug Administration for the treatment of ADHD in pediatrics. Here, we characterize the pharmacokinetics (PK) of viloxazine and its major metabolite, 5-HVLX-gluc,...

A Phase 3 Placebo-Controlled Trial of Once-Daily 400-mg and 600-mg SPN-812 (Viloxazine Extended-Release) in Adolescents with ADHD.

Psychopharmacology bulletin

Nasser A, Liranso T, Adewole T, Fry N, Hull JT, Chowdhry F, Busse GD, Melyan Z, Cutler AJ, Findling RL, Schwabe S.
PMID: 34092822
Psychopharmacol Bull. 2021 Mar 16;51(2):43-64.

OBJECTIVES: Three Phase 3 trials have demonstrated the efficacy and safety of SPN-812 in pediatric subjects with ADHD. Here, we report the results of a fourth trial.METHODS: Eligible adolescent subjects (N = 297) were randomized to SPN-812 (400- or...

Impact of Paroxetine, a Strong CYP2D6 Inhibitor, on SPN-812 (Viloxazine Extended-Release) Pharmacokinetics in Healthy Adults.

Clinical pharmacology in drug development

Wang Z, Kosheleff AR, Adeojo LW, Odebo O, Adewole T, Qin P, Maletic V, Schwabe S, Nasser A.
PMID: 33943033
Clin Pharmacol Drug Dev. 2021 Nov;10(11):1365-1374. doi: 10.1002/cpdd.948. Epub 2021 May 04.

SPN-812 (viloxazine extended-release) is a novel nonstimulant recently approved as a treatment for attention-deficit/hyperactivity disorder in children and adolescents. Given that SPN-812 is metabolized by CYP2D6 and may be coadministered with CYP2D6 inhibitors, this trial investigated the pharmacokinetics and...

Population Pharmacokinetics of Viloxazine Extended-Release Capsules in Pediatric Subjects With Attention Deficit/Hyperactivity Disorder.

Journal of clinical pharmacology

Nasser A, Gomeni R, Wang Z, Kosheleff AR, Xie L, Adeojo LW, Schwabe S.
PMID: 34269426
J Clin Pharmacol. 2021 Dec;61(12):1626-1637. doi: 10.1002/jcph.1940. Epub 2021 Aug 08.

Viloxazine extended-release capsules (viloxazine ER; Qelbree) is a novel nonstimulant, recently approved by the US Food and Drug Administration for the treatment of ADHD in pediatrics. Here, we characterize the pharmacokinetics (PK) of viloxazine and its major metabolite, 5-HVLX-gluc,...

Impact of a High-Fat Meal and Sprinkled Administration on the Bioavailability and Pharmacokinetics of Viloxazine Extended-Release Capsules (Qelbree.

European journal of drug metabolism and pharmacokinetics

Wang Z, Kosheleff AR, Adeojo LW, Odebo O, Liranso T, Schwabe S, Nasser A.
PMID: 34652564
Eur J Drug Metab Pharmacokinet. 2022 Jan;47(1):69-79. doi: 10.1007/s13318-021-00729-6. Epub 2021 Oct 15.

BACKGROUND AND OBJECTIVES: Viloxazine extended-release (viloxazine ER) capsules (QelbreeMETHODS: This was a randomized, open-label, crossover, three-treatment, three-period study in healthy adults using orally administered single-dose viloxazine ER 200 mg capsules. Subjects consumed: (1) an intact capsule after a 10-h...

Showing 1 to 12 of 23 entries