2021 Neurology Drug Approvals: Small Molecule Deep Dive

The FDA approved five novel small molecule drugs in neurology in 2021. Addressing a range of conditions from ADHD to relapsing MS, the 2021 neurology drug approvals are:

  • atogepant (Qulipta): calcitonin gene-related peptide (CGRP) receptor antagonist
  • ponsimod (Ponvory): selective sphingosine-1-phosphate (S1P) receptor 1 (S1PR1) modulator
  • samidorphan (Lybalvi): novel mu opioid receptor (MOR) antagonist (olanzipine combo)
  • serdexmethylphenidate + dexmethylphenidate (Azstarys): dexmethylphenidate plus novel prodrug
  • viloxazine (Qelbree): repurposed norepinephrine reuptake inhibitor (NRI)
samidorphan + olanzapine (Lubalvi)
atogepant (Qulipta)
viloxazine (Qelbree)
ponesimod (Ponvory)
serdexmethylphenidate + dexmethylphenidate (Azstarys)

List of Small Molecule Neurology Drug Approvals in 2021

  • olanzapine + samidorphan (Lybalvi): Adding the novel opioid mu receptor antagonist samidorphan to the established antipsychotic olanzapine creates a drug combination that demonstrated similar efficacy in treating schizophrenia as olanzapine alone, but without the weight gain that is a major source of regimen non-compliance.
  • viloxazine (Qelbree): Approved for patients ages 6-17 with ADHD, viloxazine is an oral selective norepinephrine reuptake inhibitor (NRI) formulated as extended release capsules. With a distinct mechanism of action that encompasses multiple neurotransmitter pathways, viloxazine is the first new ADHD medication approved by the FDA for children since 2009.
  • atogepant (Qulipta): Atogepant is the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved for the preventative treatment of episodic migraine in adults. Its safety profile and efficacy at doses low enough for chronic, daily dosing make it a major accomplishment in drug discovery.
  • serdexmethylphenidate + dexmethylphenidate (Azstarys): This oral combination of the CNS stimulant dexmethylphenidate and serdexmethylphenidate, a novel prodrug of dexmethylphenidate, is approved for the first-line treatment of ADHD in patients six years and older. Its controlled-release formulation offers a more stable biological concentration of active drug throughout the day, which can prevent morning and evening spikes in ADHD symptoms.
  • ponisimod (Ponvory): Ponsimod is an oral, selective sphingosine-1-phosphate (S1P) receptor 1 (S1PR1) modulator approved for the treatment of relapsing forms of MS in adults. Its approval was based in part on improved efficacy over teriflunomide in a randomized, global superiority study.

Premium Slide Deck – Neurology 2021

In the Premium slide deck, we explore each of these novel small molecule drug approvals in neurology in greater detail, including their mechanisms of action, what separates them from previous generations of molecules, the clinical data, the originators, and more.

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Qulipta (atogepant)

Qulipta (atogepant), marketed by AbbVie is an oral (10, 20, or 60 mg) calcitonin gene-related peptide (CGRP) receptor antagonist approved in adults for the preventative treatment of episodic migraine. In two Phase III randomized trials, patients who received atogepant experienced, on average, one to two fewer migraine days monthly than patients who received placebo. In one of the studies, patients on atogepant also had fewer monthly medication use days compared with those on placebo.

Differentiation from Prior Molecules

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