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Evaluation of the Excretion of Viloxazine and Its Metabolite 5-Hydroxy-viloxazine Glucuronide Into Breast Milk Following Multiple Doses of SPN-812 (600mg, QD) in Healthy Lactating Women

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Trial Profile

Evaluation of the Excretion of Viloxazine and Its Metabolite 5-Hydroxy-viloxazine Glucuronide Into Breast Milk Following Multiple Doses of SPN-812 (600mg, QD) in Healthy Lactating Women

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 30 Jan 2025

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At a glance

  • Drugs Viloxazine (Primary)
  • Indications Attention-deficit hyperactivity disorder
  • Focus Pharmacokinetics
  • Sponsors Supernus Pharmaceuticals

    • Most Recent Events

    • 27 Jan 2025 Results presented in the Supernus Pharmaceuticals Media Release
    • 27 Jan 2025 According to Supernus Pharmaceuticals media release, company announced that the U.S. Food and Drug Administration (FDA) has approved an update for the label for Qelbree (viloxazine extended-release capsules) to include new pharmacodynamic data in Section 12.2. The updated label describes viloxazines partial agonist activity at the serotonin 5-HT2C receptor and inhibition of the norepinephrine transporter, reinforcing its multimodal pharmacodynamic profile.
    • 20 Feb 2024 New trial record

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