sNDA Submission (Meeting with FDA)
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Catalyst Info & Data Links
TITLE: ZX008 in Lennox-Gastaut syndrome - sNDA Submission (Meeting with FDA)
ClinicalTrial.gov (NCT03355209): A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome
ClinicalTrial.gov (NCT03936777): A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome
WHAT IS THE CATALYST EVENT?
WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?
04-2020: Corporate Overview (slide 5, 12)
2018: A pilot, open‐label study of the effectiveness and tolerability of low‐dose ZX 008 (fenfluramine HC l) in Lennox‐Gastaut syndrome. Epilepsia, 59(10), 1881-1888.
2019: A phase I, randomized, open-label, single-dose, 3-period crossover study to evaluate the drug-drug interaction between ZX008 (fenfluramine HCl oral solution) and a regimen of stiripentol, clobazam, and valproate in healthy subjects. International journal of clinical pharmacology and therapeutics, 57(1), 11.
EPIDIOLEX® (cannabidiol) - GW Pharmaceuticals
~1 to 2 per million people (learn more)
MECHANISM OF ACTION / RATIONALE
Fenfluramine's antiepileptic activity is thought to arise from agonist activity of neuronally released serotonin (5‐HT) or via a direct agonist effect on 5‐HT receptors (5HT1D and 5HT2C). Additionally, fenfluramine has been shown to have effects on sigma 1 receptors, which have been implicated as having a role in epilepsy (Lagae et al., 2018).
Updated by HC
#ZGNX, #ZX008, #Lennox-Gastaut_syndrome, #sNDA
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Trial Design / Revenue (click to view full image)
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