SUPN

SPN-812 (viloxazine hydrochloride)

Attention deficit hyperactivity disorder (ADHD)

NDA Resubmission

Exp Date

TBD

Amp Volatility Score

N/A

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?

  • NDA Resubmission


WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?

  • TBD


PRIOR DATA

PRESS RELEASES


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

Prior Data (click to view full image)

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Trial Design / Revenue (click to view full image)

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Recent Posts

See What The Community Is Saying - Click To See Full Post

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SUPN - Complete Response Lette...

#SUPN received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA). The CRL is "regarding the New Drug Application (NDA) for SPN-812 for the treatment of ADHD in pediatri...

SUPN - Supernus Announces Thir...

Summary: Q3 2020 total revenues of $155.1 million, including net product sales of $152.1 million and royalty revenues of $3.0 million Q3 2020 operating earnings of $56.1 million On track to initiate...

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