Dasotraline in ADHD: novel or me too drug?

ABSTRACT

Introduction: A ‘holy grail’ of treatment options for attention-deficit hyperactivity disorder (ADHD) has been an agent with low abuse potential and peak-trough clinical effects, providing sustained therapeutic benefits throughout the day. One such agent, dasotraline, a dopamine and norepinephrine reuptake inhibitor agent, was recently reviewed by the FDA.

Areas covered: The authors completed a timely drug review using a PubMed literature search using words ‘Dasotraline, ADHD’ ‘stimulant, abuse’ ‘atomoxetine, ADHD.’ FDA fact sheets of available medications were reviewed for comparison of safety and tolerability data. The authors reviewed preclinical, efficacy, and safety trials of dasotraline in ADHD: two phase 1, one phase 2, and several phase 3 trials have established efficacy in reducing ADHD symptoms.

Expert opinion: Due to its stable plasma concentrations with once-daily dosing, dasotraline could have sustained treatment benefits for ADHD, with low abuse potential and a stable therapeutic response over a 24-h period.

KEYWORDS:

• Dasotraline
• ADHD
• pharmacokinetics
• proof-of-concept trial

Declaration of interest

E Arnold has received research funding from, Forest, Lilly, Noven, Shire, Supernus, Roche, and YoungLiving, as well as NIH and Autism Speaks. E Arnold has also consulted with Pfizer, Tris Pharma, and Waypoint, and has been on advisory boards for Arbor, Ironshore, Otsuka, Pfizer, Roche, Seaside Therapeutics, Shire. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or conflict with the subject matter or materials discussed in this manuscript apart from those disclosed.

Reviewer disclosures

A peer reviewer on this manuscript is a co-founder of Avekshan LLC, Tallahassee, FL a pharmaceutical company that is developing novel treatments for ADHD. One of the products being developed by Avekshan is an abuse deterrent formulation of methylphenidate. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Additional information

Funding

This paper was not funded.