MedPath

Fenfluramine

Generic Name
Fenfluramine
Brand Names
Fintepla
Drug Type
Small Molecule
Chemical Formula
C12H16F3N
CAS Number
458-24-2
Unique Ingredient Identifier
2DS058H2CF

Overview

Dravet syndrome is a pediatric encephalopathy that typically manifests within the first year of life following exposure to elevated temperatures. It is characterized by recurrent pharmacoresistant seizures, which increase in frequency and severity with disease progression. Concomitantly with these seizures, patients typically display delayed development and neurocognitive impairment. Fenfluramine is a serotonergic phenethylamine originally used as an appetite suppressant until concerns regarding cardiotoxicity in obese patients lead to its withdrawal from the market in 1997. Through its ability to modulate neurotransmission, fenfluramine has reemerged as an effective therapy against pharmacoresistant seizures, such as those involved in Dravet syndrome. Fenfluramine was granted initial FDA approval in 1973 prior to its withdrawal; it was granted a new FDA approval on June 25, 2020, for treatment of patients with Dravet syndrome and Lennox-Gastaut syndrome through the restricted FINTEPLA REMS program. It is currently sold under the name FINTEPLA® by Zogenix INC.

Background

Dravet syndrome is a pediatric encephalopathy that typically manifests within the first year of life following exposure to elevated temperatures. It is characterized by recurrent pharmacoresistant seizures, which increase in frequency and severity with disease progression. Concomitantly with these seizures, patients typically display delayed development and neurocognitive impairment. Fenfluramine is a serotonergic phenethylamine originally used as an appetite suppressant until concerns regarding cardiotoxicity in obese patients lead to its withdrawal from the market in 1997. Through its ability to modulate neurotransmission, fenfluramine has reemerged as an effective therapy against pharmacoresistant seizures, such as those involved in Dravet syndrome. Fenfluramine was granted initial FDA approval in 1973 prior to its withdrawal; it was granted a new FDA approval on June 25, 2020, for treatment of patients with Dravet syndrome and Lennox-Gastaut syndrome through the restricted FINTEPLA REMS program. It is currently sold under the name FINTEPLA® by Zogenix INC.

Indication

Fenfluramine is indicated for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in patients aged two years and older.

Associated Conditions

  • Seizures

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2024/11/07
Phase 1
Active, not recruiting
2024/09/19
Phase 4
Recruiting
2023/11/07
Phase 3
Recruiting
2022/09/29
Phase 3
Not yet recruiting
2022/02/10
Phase 4
Recruiting
Hospital Ruber Internacional
2021/08/30
Phase 4
Completed
2020/06/18
N/A
AVAILABLE
2020/02/28
Phase 2
Recruiting
2019/03/04
Phase 2
Completed
2018/12/31
Phase 3
Completed
Elizabeth Anne Thiele

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
UCB, Inc.
43376-322
ORAL
2.2 mg in 1 mL
12/14/2023

EMA Drug Approvals

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
FINTEPLA fenfluramine 2.2 mg/mL Oral Solution Bottle
429413
Medicine
A
11/28/2024
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