Now approved in Europe for patients 2 years of age and older experiencing seizures associated with Dravet syndrome

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A new standard in seizure control

Fintepla (fenfluramine) is indicated for the treatment of seizures associated with Dravet syndrome as an add-on therapy to other antiepileptic medicines for patients 2 years of age and older.1

Is Fintepla the next step for your
patients with Dravet syndrome?

Launch of Fintepla in Europe

On the 11th February 2021, a live interactive session was streamed to healthcare professionals in Europe, announcing the launch of Fintepla. The meeting included expert presentations from Prof. Lieven Lagae, Prof. Rima Nabbout and Prof. Julia Jacobs and the content is available on-demand now.

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Dr. Nicola Specchio

Bambino Gesù Children’s Hospital, Rome, Italy

“My personal view is that we should start treating patients quite early in the disease course and we should consider Fintepla as one of the first add-on therapy for those patients.”

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Prof. Sameer Zuberi

Royal Hospital for Children, Glasgow, Scotland

“Any new option for improving seizure frequency and improving their child's quality of life and their family's quality of life, will be regarded with great enthusiasm and positivity by families and family organisations."

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See Fintepla’s unique mechanism of action

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Fintepla demonstrated significant convulsive seizure frequency reduction in patients aged 2-18 years with Dravet syndrome2

When added to an existing antiepileptic drug (AED) regimen (without concomitant stiripentol) Fintepla 0.7mg/kg/day showed a 62.3% greater reduction in mean monthly convulsive seizure frequency than with placebo (primary endpoint) (P<0.0001)

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In a 14-week multicentre, randomised, double-blind, parallel group, placebo-controlled study with add-on Fintepla 0.7mg/kg/day (Study 1):2

0%

of patients experienced a ≥50% reduction in mean monthly convulsive seizure frequency (key secondary endpoint)

0%

of patients experienced a ≥75% reduction in mean monthly convulsive seizure frequency (secondary endpoint)

0%

of patients achieved near seizure freedom* (post-hoc analysis)

*Defined as 0 or 1 convulsive seizure during the 14-week treatment period

In a phase 3, randomised, double-blind, placebo-controlled study (Study 2), Fintepla 0.4mg/kg/day showed a greater reduction in mean monthly convulsive seizure frequency than those receiving placebo, when added to an antiepileptic drug (AED) regimen containing stiripentol (primary endpoint)3


Fintepla 0.4mg/kg/day reduced convulsive seizure frequency by ≥50% in 54% of patients when added to an AED regimen containing stiripentol (key secondary endpoint)3

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Previously Study 1504

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In an open-label extension study Fintepla demonstrated consistent and sustained control in convulsive seizures up to 36 months in patients with Dravet syndrome4


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Patients experienced a median reduction in monthly convulsive seizure frequency of 64.5% over the entire treatment period (median treatment duration of 631 days)4 


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Fintepla is a new, adjunctive treatment for seizures associated with Dravet syndrome for patients 2 years of age and older. The unique mode of action of Fintepla targets the serotonergic system and sigma-1 receptors 5,6

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The exact mechanism by which Fintepla exerts its therapeutic effects in the treatment of seizures in Dravet syndrome is unknown. 1

effect of fenfluramine on the serotonergic system

The effect of Fintepla on the serotonergic system

View references

  1. Fintepla Summary of Product Characteristics. 
  2. Lagae L, Sullivan J, Knupp K, et al; FAiRE DS Study Group. Fenfluramine hydrochloride for the treatment of seizures in Dravet syndrome: a randomised, double-blind, placebo-controlled trial. Lancet.2019;394(10216):2243-2254.
  3. Nabbout R, Mistry A, Zuberi S, et al. Fenfluramine for treatment-resistant seizures in patients with Dravet syndrome receiving stiripentol-inclusive regimens: a randomized clinical trial. JAMA Neurol. 2020;77(3):300-308.
  4. Scheffer E, Devinsky O, Perry S, et al. Efficacy and Tolerability of Adjunctive FINTEPLA (Fenfluramine HCl) in an Open-Label Extension Study of Dravet Syndrome Patients Treated for Up to 3 Years. Presented at: the Virtual American Epilepsy Society (AES) Annual Meeting; December 4-8, 2020.
  5. Rothman RB, Baumann MH. Therapeutic and adverse actions of serotonin transporter substrates. Pharmacology & Therapeutics. 2002;95(1):73-88.
  6. Martin P, de Witte PAM, Maurice T, et al. Fenfluramine acts as a positive modulator of sigma-1 receptors. Epilepsy & Behavior. 2020;105:1-9.

Adverse events should be reported.

Please refer to section 4.8 of the SmPC for national reporting requirements in your country.

Adverse events should also be reported to Zogenix International Limited on +44 (0)800 060 8767 or email medinfo.eu@zogenix.com