viloxazine (SPN-809) / Supernus Pharma - LARVOL DELTA

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

The role of adrenergic neurotransmitter reuptake inhibitors in the ADHD armamentarium. (PubMed, Expert Opin Pharmacother) - "The authors conducted a PubMed literature search using the following key words: 'ADHD' AND 'adrenergic reuptake inhibitors' OR 'nonstimulants' OR 'atomoxetine' OR 'Viloxazine' OR 'Dasotraline' OR 'Centanafadine' OR 'PDC-1421' OR 'Reboxetine' OR 'Edivoxetine' OR 'Bupropion' OR 'Venlafaxine' OR 'Duloxetine.' They reviewed FDA fact sheets of available medications for safety/tolerability studies and reviewed published clinical studies of these medications for treatment of ADHD. Adrenergic neurotransmitter reuptake inhibitors fit the diverse needs of children and adolescents with ADHD with 1) poor tolerability to stimulants (e.g. due to growth suppression, insomnia, rebound irritability, co-morbid depression, anxiety and tic disorders, substance abuse or diversion concerns), 2) cardiac risks, and/or 3) need for extended duration of action. Their differences in receptor..."

Journal • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Depression • Insomnia • Mood Disorders • Psychiatry • Sleep Disorder • Substance Abuse • Tic Disorders • Tourette Syndrome

Adverse event profiles of drug-induced liver injury caused by antidepressant drugs: a disproportionality analysis. (PubMed, Ther Adv Drug Saf) - "Among the identified 42 antidepressants, nefazodone (n = 47, ROR = 7.79, IC = 2.91), fluvoxamine (n = 29, ROR = 4.69, IC = 2.20), and clomipramine (n = 24, ROR = 3.97, IC = 1.96) had the highest ROR for cholestatic injury; mianserin (n = 3, ROR = 21.46, IC = 3.99), nefazodone (n = 264, ROR = 18.67, IC = 3.84), and maprotiline (n = 15, ROR = 5.65, IC = 2.39) for hepatocellular injury; and nefazodone (n = 187, ROR = 12.71, IC = 0.48), clomipramine (n = 35, ROR = 2.07, IC = 0.26), and mirtazapine (n = 483, ROR = 1.96, IC = 0.94) for severe drug-related hepatic disorders...There are limited reports on the adverse reactions of relatively new antidepressant drugs, such as milnacipran, viloxazine, esketamine, and tianeptine, and those not approved by the Food and Drugs Administration, such as reboxetine and agomelatine...Duloxetine and clomipramine were associated with three DILI categories, except hepatic failure. The disproportionality analysis cannot conclude on a definite..."

Adverse events • Journal • CNS Disorders • Depression • Hepatology • Liver Failure • Mental Retardation • Psychiatry

Baseline Characteristics of Pediatric and Adult Patients with ADHD Prescribed Viloxazine ER, Stimulants or Atomoxetine, in Open Claims Data (ISPOR 2024) - "OBJECTIVES: The novel non-stimulant Viloxazine ER (VLX; Qelbree®) received FDA approval for the treatment of pediatric (ages 6-17) ADHD in 2021 and adult ADHD in 2022... Across all age groups, patients filling prescriptions for novel VLX regimens tended to be younger and have more psychiatric diagnoses than those filling prescriptions for ATX regimens or stimulants. Further research is needed to determine whether the greater psychiatric complexity in patients receiving prescriptions for VLX regimens results from its recent market entry or prescription step-therapy rules; however, these demographic factors are important to consider in outcomes analyses."

Clinical • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • Autism Spectrum Disorder • CNS Disorders • Depression • Genetic Disorders • Mood Disorders • Pediatrics • Psychiatry

Adult attention deficit hyperactivity disorder: a comprehensive review. (PubMed, Ann Med Surg (Lond)) - "They include atomoxetine and viloxazine...The following search strings and Medical Subject Headings (MeSH) terms were used: "Viloxazine," "ADHD," "Stimulants," and "adult ADHD." We explored the literature on the growing knowledge of Viloxazine. A thorough review of the history, mechanism of action, pharmacokinetics, and drug-drug interactions are reviewed here with special attention on treatment in adults with comorbid conditions."

Journal • Review • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • Bipolar Disorder • Cardiovascular • CNS Disorders • Depression • Epilepsy • Mood Disorders • Psychiatry

A Comprehensive Review of Novel FDA Approved Psychiatric Indications From 2018-2022 (APA 2023) - "In 2019, Zulresso (brexanolone) was approved for postpartum depression, Caplyta (lumateperone) for schizophrenia, and Dayvigo (lemborexant) for insomnia. Azstarys (serdexmethylphenidate/dexmethylphenidate) and Qelbree (viloxazine) were both FDA approved in 2021 for ADHD. The newest FDA approvals include Quvivig (daridorexant) for insomnia and Auvelity (dextromethorphan/bupropion) for major depressive disorder... We found 8 novel psychiatric indications out of 226 total pharmaceuticals approved by the US Food and Drug Administration within the years of 2018 and 2022, representing 3.5% of total FDA approvals during that time period. Clinical trials for each medication suggested favorable results in Phase III trials that lead to approval, along with current success in Phase IV trials as well. In 2018, Lucemyra (lofexidine) was approved for the treatment of opioid withdrawal."

FDA event • Review • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Depression • Developmental Disorders • Insomnia • Major Depressive Disorder • Mental Retardation • Mood Disorders • Postpartum Depression • Psychiatry • Schizophrenia • Sleep Disorder

Pharmacologic Management of Cognitive Disengagement Syndrome (CDS) and Implications for Attention-Deficit/Hyperactivity Disorder (ADHD) Treatment: Emerging Treatments and Recommendations for Future Research. (PubMed, CNS Drugs) - "At present, the limited existing literature suggests that psychostimulants such as methylphenidate and lisdexamfetamine, as well as atomoxetine, may improve CDS symptoms, although replication and research on related medications is needed...Although untested, research on the neurobiological, neuropsychological, and behavioral correlates of CDS point to a possible benefit of other ADHD medications (e.g., guanfacine), medications that treat narcolepsy (e.g., modafinil), and medications traditionally used to treat depression and anxiety (e.g., viloxazine, bupropion, fluvoxamine), some of which have also recently been used in ADHD management. The article concludes with recommendations for future research on pharmacologic treatment and CDS."

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

Viloxazine in attention deficit hyperactivity disorder : current evidence (ECNP 2022) - "Dysregulation of norepinephrine (NE) and dopamine (DA) contributes to symptoms of inattention and deficits in executive decision-making in ADHD, and serotonin (5-HT) dysregulation has been linked to the hyperlocomotor activity [1].Viloxazine was first discovered when scientists tried to synthesize compounds with propranolol-like structures with central nervous system modulating properties...Retrieved papers (1997-2021) were selected according to their relevance. Result s : Viloxazine was initially characterized as a NRI [2] but recent investigations suggests that it has a distinct clinical profile comparing to others NRIs such as atomoxetine, already used on the ADHD treatment... Contemporary investigations of the drugs already commercialized should be conducted, to better understand its mechanisms of action and future clinical applications. Viloxazine extended-release is recently approved for the treatment of ADHD in adults, with an acceptable safety and..."

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

Viloxazine for the Treatment of Attention Deficit Hyperactivity Disorder. (PubMed, Health Psychol Res) - "Stimulants, such as methylphenidate and amphetamines, are the mainstay of treatment for ADHD. However, nonstimulant drugs such as viloxazine, atomoxetine, guanfacine, and clonidine are becoming more popular due to minimal adverse effects when compared to stimulants...Viloxazine is a recently approved, non-stimulant medication functions by inhibiting the uptake of norepinephrine which has been seen to be decreased in patients with ADHD. When patients do not respond to first-line stimulants, cannot tolerate the side effects, or have contraindications to stimulants, viloxazine may be a nonstimulant option offering patients an increasing arsenal of medications to treat ADHD."

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

Extended-Release Viloxazine for Children and Adolescents With Attention Deficit Hyperactivity Disorder. (PubMed, J Pediatr Pharmacol Ther) - "Non-stimulant medication therapy for children, adolescents, and young adults with attention-deficit/hyperactivity disorder (ADHD) has included alpha 2-agonists (guanfacine and clonidine) as well as a norepinephrine reuptake inhibitor (atomoxetine) for multiple years...Extended-release viloxazine (SPN-812) has been shown in phase 2 and phase 3 trials to be an effective, well-tolerated alternative for some children with ADHD...Although continued evaluation to confirm the reduced symptoms of ADHD in children along with the safety profile is needed, extended-release viloxazine may offer a once-a-day pharmaceutical treatment option for patients in which stimulant medication is not effective or not a favorable option. It may also be beneficial for those children and adolescents with a comorbidity of depression."

Journal • Review • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Depression • Pain • Psychiatry • Suicidal Ideation

Viloxazine: Pediatric First Approval. (PubMed, Paediatr Drugs) - "Viloxazine (QELBREE), a selective norepinephrine reuptake inhibitor, is being developed by Supernus Pharmaceuticals as a non-stimulant for the treatment of attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients...Viloxazine is available as extended-release capsules for once-daily oral administration. This article summarizes the milestones in the development of viloxazine leading to this first pediatric approval for ADHD."

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

Viloxazine in the Management of CNS Disorders: A Historical Overview and Current Status. (PubMed, CNS Drugs) - "This review summarizes the evolving knowledge of viloxazine based on information from previously published preclinical and clinical investigations, and acquired unpublished historical study reports from both open-label and blinded controlled clinical trials. We review the chemical properties, mechanism of action, safety, and tolerability across these studies, and discuss the contemporary rationale for the development of this agent as an extended-release oral formulation for the treatment of attention-deficit/hyperactivity disorder."

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

The emergence of new antidepressants for clinical use: Agomelatine paradox versus other novel agents. (PubMed, IBRO Rep) - "...The emerging antidepressants are: selective monoamine oxidase inhibitors (MAOIs) such as bifemelane, pirlindole, toloxatone, selegiline, rasagiline and safinamide; serotonin-norepinephrine reuptake inhibitors (SNRIs) such as ansofaxine, nefopam and levomilnacipran; norepinephrine reuptake inhibitors (NRIs) such as Reboxetine, viloxazine, teniloxazine (also known as sulfoxazine or sufoxazine), and atomoxetine; Vilazodone (a serotonin 5-HT autoreceptor partial agonist with serotonin reuptake inhibition [SPARI]); Vortioxetine (a serotonin receptors antagonist with serotonin reuptake inhibition [SARI]); atypical antipsychotics such as olanzapine, quetiapine, risperidone, lurasidone, aripiprazole and brexpiprazole; N-methyl-d-aspartate (NMDA)-glutamatergic neurotransmission system blockers such as ketamine, CP-101,606 (traxoprodil), GLYX-13 (rapastinel), NRX-1074 (Apimostinel) and Riluzole...receptors antagonist [MASSA]) remains a paradoxical agent that doesn't fit..."

Clinical • Journal • Review