PurposeThe limitations of current US Food and Drug Administration (FDA)–approved medications for the treatment attention-deficit/hyperactivity disorder (ADHD) set need development novel, effective, tolerable to treat this disorder. The purpose study was evaluate whether with SPN-812 (viloxazine extended-release) significantly reduces symptoms ADHD in children.MethodsThis a randomized, double-blind, placebo-controlled 6-week trial assess efficacy safety once-daily 100- 200-mg male female...

Attention-deficit/hyperactivity disorder is a neurodevelopmental that typically begins in childhood and often persists into adulthood. Recent phase III trials have demonstrated the efficacy safety of viloxazine extended-release capsules (viloxazine ER; Qelbree®) pediatrics (6–17 years age). The aim this study was to evaluate ER adults with attention-deficit/hyperactivity disorder. This III, randomized, double-blind, placebo-controlled, two-arm trial (18–65 age) Eligible subjects were...

Objective: The objective of this study is to evaluate efficacy and safety SPN-812 (extended-release viloxazine) for ADHD in children aged 6 12 years. Method: In an 8-week study, 222 participants were randomized placebo or 100, 200, 300, 400 mg/day. Measurements included Rating Scale (RS)-IV total score Clinical Global Impression-Severity (CGI-S) Impression-Improvement (CGI-I) scores. Safety assessments laboratory electrocardiogram (ECG) measurements, suicidality monitoring (Columbia-Suicide...

A major goal for the treatment of opioid use disorder is to reduce or eliminate illicit opioids. Buprenorphine, a μ-opioid receptor partial agonist and kappa antagonist, now being developed as monthly, sustained-release formulation (RBP-6000). The objective this study was demonstrate that RBP-6000 blocks subjective effects reinforcing efficacy hydromorphone (intramuscularly administered) in subjects with moderate severe disorder. Subjects were first inducted dose stabilized on sublingual...

This phase 3 clinical trial evaluated the efficacy and safety of viloxazine extended-release capsules (VLX-ER) as a monotherapy for attention-deficit/hyperactivity disorder (ADHD) in adolescents (12-17 years).

RBP-6000 is a novel sustained-release formulation of buprenorphine for the treatment opioid use disorder, which has been designed once-monthly (28 days) subcutaneous (SC) injections. A population pharmacokinetic (PK) model was developed to describe time course plasma concentrations after repeated SC injections at 50 mg, 100 200 or 300 mg in treatment-seeking opioid-dependent subjects previously on sublingual (Subutex(®) ) treatment. The μ-opioid receptor occupancy predicted using PK/PD Emax...

Machine learning (ML) was used to determine whether early response can predict efficacy outcome in pediatric subjects with ADHD treated SPN-812. We data from four Phase 3 placebo-controlled trials of 100- 600-mg/day SPN-812 (N=1397; 6-17 years age). The treatment defined as having a ≥50% reduction change baseline (CFB) Rating Scale-5 (ADHD-RS-5) Total score at Week 6. variables were: ADHD-RS-5 score, age, body weight, and mass index baseline; CFB 1, cumulative 2, 3; Clinical Global...

Abstract Background Viloxazine extended-release is a novel nonstimulant under investigation as potential treatment for attention-deficit/hyperactivity disorder (ADHD). Given the viloxazine to be co-administered with stimulant ADHD pharmacotherapies, this trial investigated pharmacokinetics and safety of combination + lisdexamfetamine dimesylate (lisdexamfetamine) versus alone. Methods In single-center, cross-over, open-label trial, healthy, non-ADHD adults received single oral doses 700 mg...

Abstract RBP‐7000 is a sustained‐release (once‐monthly injection for subcutaneous administration) formulation of risperidone using the ATRIGEL® Delivery System, developed treatment schizophrenia to address compliance issues associated with oral administration. The objective this analysis was report results population pharmacokinetic and describe relationship between 9‐hydroxyrisperidone levels dopamine (DA) D2‐receptor occupancy, prolactin levels, adverse events data collected in 45...

RBP-8000 is a double mutant cocaine esterase that rapidly metabolizes cocaine. This study was conducted to assess the pharmacokinetics of and cocaine-induced physiological effects in absence (placebo) or presence RBP-8000. Twenty-nine abusers were randomized 1:1 (active: placebo) 4 sequences 2 treatment periods. In RBP-8000, plasma exposures dropped by 90% within min; significantly reduced with higher extent faster decrease systolic blood pressure pulse rate compared placebo. provides strong...

RBP-7000 is a long-acting formulation of risperidone designed for once-monthly subcutaneous injection the treatment schizophrenia. The objective was to estimate clinically effective doses based on model simulations and comparison with other injectable antipsychotics. A population pharmacokinetic developed in 90 stable schizophrenic patients having received single/repeated 60, 90, or 120 mg. Model were conducted compare active moiety plasma exposure after repeated administrations published...

Viloxazine extended-release (viloxazine ER, SPN-812) is a novel non-stimulant with activity at serotonin receptors and the norepinephrine transporter, which under investigation as potential treatment for attention-deficit/hyperactivity disorder. Given viloxazine ER to be coadministered other pharmacotherapies, this trial investigated pharmacokinetics safety of combination + methylphenidate versus or alone. In single-center, crossover, open-label trial, healthy adult participants received...

Purpose: The ADHD Rating Scale (ADHD-RS) assesses 18 symptoms of inattention and hyperactivity/impulsivity has been used in many clinical trials to evaluate the treatment effect drugs on ADHD. fifth edition this scale (ADHD-RS-5) also impact six domains functional impairment (FI): family relationships, peer completing/returning homework, academic performance at school, controlling behavior self-esteem. Here, we report viloxazine extended-release capsules (viloxazine ER), a novel nonstimulant...

Abstract Viloxazine extended‐release capsules (viloxazine ER; Qelbree) is a novel nonstimulant, recently approved by the US Food and Drug Administration for treatment of ADHD in pediatrics. Here, we characterize pharmacokinetics (PK) viloxazine its major metabolite, 5‐HVLX‐gluc, using population PK model evaluate impact 1‐4 days missed ER doses on PK. Data from 4 phase 3 trials pediatric subjects treated with were used to establish model. Covariate analysis was conducted final base The...

Early response to viloxazine extended-release (viloxazine ER, Qelbree®) treatment predicted efficacy outcome in pediatric subjects with attention-deficit/hyperactivity disorder (ADHD). This study sought determine whether the machine learning lasso model used would predict ER an adult population based on early improvements ADHD symptoms. We data from a double-blind, placebo-controlled, flexible-dose (200-600 mg) of (N = 354; 18 60 years old). Area under Receiver Operating Characteristic Curve...

Objectives: Clinical trials in psychiatry frequently report results from lengthy, comprehensive assessments to characterize a subject emotionally, cognitively, and behaviorally before after treatment. However, the potential treatment implications of these how they translate into clinical practice remain unclear. Conversely, Global Impressions (CGI) scales are quick, intuitive used assess functional impact clinically relevant terms. The objectives present analyses scores symptom severity...

The aim of this study was to evaluate the effect viloxazine extended-release capsules (viloxazine ER; Qelbree™) on executive function deficits (EFDs) in pediatric subjects (6–17 years age) with attention-deficit/hyperactivity disorder (ADHD). Data from four phase III placebo-controlled trials 100–600 mg/day ER (6–8 weeks treatment) were used change baseline (CFB) Conners 3rd Edition Parent Short Form—Executive Function (C3PS-EF) content scale T-score. Subjects defined as EFD responders if...

Attention-deficit/hyperactivity disorder (ADHD) is associated with impairments related to peer relations (PR) and social activities (SA). The objective of this post hoc analysis was assess the degree which viloxazine extended-release (viloxazine ER; capsules; Qelbree® ) improves clinical assessments PR SA in children adolescents ADHD.Data were used from four Phase III placebo-controlled trials 100 600 mg/day ER (N = 1354; 6-17 years age). measured Peer Relations content scale Conners 3rd...