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Catalyst Info & Data Links
TITLE: SPN-812 (viloxazine hydrochloride) in ADHD - NDA Resubmission
ClinicalTrial.gov (NCT03247530): Evaluation of SPN-812 ER Low Dose in Children With ADHD
ClinicalTrial.gov (NCT03247517): Evaluation of SPN-812 ER Low Dose in Adolescents With ADHD
ClinicalTrial.gov (NCT03247556): Evaluation of SPN-812 ER High Dose in Adolescents With ADHD
ClinicalTrial.gov (NCT03247543): Evaluation of SPN-812 ER High Dose in Children With ADHD
WHAT IS THE NEXT CATALYST EVENT?
WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?
11-09-2020 Regulatory Updates for SPN-812 and SPN-830
2020: A phase II double-blind, placebo-controlled, efficacy and safety study of SPN-812 (extended-release viloxazine) in children with ADHD. Journal of attention disorders, 24(2), 348-358.
MECHANISM OF ACTION / RATIONALE
SPN-812 is a serotonin norepinephrine modulating agent (SNMA) that Supernus is developing as a novel non-stimulant for the treatment of ADHD. Based on data generated to date, the Company believes SPN-812 could be a well-differentiated ADHD treatment compared to other treatments for ADHD due to its novel mechanism of action and unique pharmacological and pharmacokinetic profile. The active ingredient in SPN-812, viloxazine hydrochloride, has an extensive safety record in Europe, where it was previously marketed for many years as an antidepressant.
Updated by HC
SUPN, SPN-812, Attention deficit hyperactivity disorder, ADHD, PDUFA, mental health
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