metadoxine extended-release (MG01CI) / Arcturus Therap - LARVOL DELTA

Updates in treatment strategies in ADHD (WFSBP 2026) - "Lisdexamfetamine, a prodrug cleaved gradually by red blood cell enzymes, provides smoother pharmacokinetics and lower abuse potential due to slower peak concentrations...OROS-methylphenidate mimics twice-daily dosing through osmotic release, while transdermal methylphenidate bypasses first-pass metabolism and reduces appetite suppression. Serdexmethylphenidate and ion-exchange amphetamine preparations further improve duration and plasma stability...These mechanisms may improve emotional dysregulation and provide faster onset than atomoxetine...Investigational therapies include centanafadine, a triple DAT-NET-SERT inhibitor targeting emotional dysregulation; TAAR-1 agonists, which modulate dopamine and glutamate signaling; and metadoxine extended release, which restores GABA-glutamate balance and may preferentially benefit inattentive ADHD...DAT1 and SERT polymorphisms may predict stimulant or serotonergic treatment response, while COMT Val158Met variants influence..."

ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Mood Disorders • Psychiatry • Tic Disorders • Tourette Syndrome • COMT

The MEASURE Study - A Phase 3 Study of MDX 1400 mg Daily Compared With Placebo in Adults With ADHD (clinicaltrials.gov) - P3; N=283; Terminated; Sponsor: Alcobra Ltd.; N=750 ➔ 283; Suspended ➔ Terminated; Trial primary completion date: Oct 2016 ➔ Jan 2017

Enrollment change • Trial primary completion date • Trial termination • Attention Deficit Hyperactivity Disorder • Biosimilar • CNS Disorders

The MEASURE Study - A Phase 3 Study of MDX 1400 mg Daily Compared With Placebo in Adults With ADHD (clinicaltrials.gov) - P3; N=750; Recruiting; Sponsor: Alcobra Ltd.; Trial primary completion date: Apr 2016 ➔ Oct 2016

Trial primary completion date • Biosimilar

The Placebo Response in Adult ADHD as Objectively Assessed by the TOVA Continuous Performance Test. (PubMed, J Atten Disord) - " A retrospective data analysis from a double-blind placebo-controlled study of metadoxine-ER in adults with ADHD. An additional database was used for comparison to TOVA response after methylphenidate challenge (TOVA-MPH-R)... TOVA-PR has an index-specific profile compared with CAARS-PR and TOVA-MPH-R. The partial correlation of TOVA-PR with CAARS-PR suggests that a composite score of TOVA specific indices and CAARS could have a synergic impact to improve the reliability of the response assessment in adult ADHD."

Clinical • Journal