Case Study in Placebo Modeling and Its Effect on Drug Development

Authors: Passarell JA
Conference: ASCPT
Keywords: ADHD (attention-deficit/hyperactivity disorder), neurodevelopmental disorder
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Background

  • ADHD (attention-deficit/hyperactivity disorder) is a neurodevelopmental
    disorder characterized by symptoms of inattention, hyperactivity, and
    impulsivity associated with clinically significant impairment in functioning
  • Dasotraline
    [(1R,4S)-4-(3,4-Dichlorophenyl)-1,2,3,4-tetrahydronaphthalen-1-amine]

    • novel compound in clinical development for treatment of ADHD
    • is potent inhibitor of human dopamine transporters (DAT) and norepinephrine
      transporters (NET), and weaker inhibitor of human serotonin transporters (SERT)
    • pharmacokinetic (PK) profile of slow absorption/elimination is unique among current
      stimulant and non-stimulant medications indicated for ADHD, and allows for once
      daily dosing

American Chemical Society for Clinical Pharmacology & Therapeutics 2018 Annual Meeting, March 21-24, 2018, Orlando, Florida

By Julie A Passarell