After its approval in Europe in December, Fintepla (fenuramine) now is commercially available in Germany as an add-on treatment for seizures associated with Dravet syndrome in patients 2 and older, the therapy’s developer, Zogenix, recently announced.
“With the launch of FINTEPLA in Germany, physicians and caregivers here can now access an urgently needed, effective and generally well-tolerated new treatment option to help reach their goals of reducing the devastating seizures and improving outcomes and quality of life for patients and their families,” Jens Grunert, MD, medical director of Zogenix Germany, said in a press release.
Beginning this month, Fintepla will be available in Germany under a controlled access program requested by the European Medicines Agency to prevent off-label use for weight management and ensure physicians are aware of patient monitoring requirements. More details are available here. Physicians will have to register for an identification number before being able to prescribe the therapy.
Fintepla is an oral, low-dose solution of fenuramine hydrochloride — an amphetamine derivative that has appetite-suppressant properties — and works by blocking the re-uptake of serotonin, an important neurotransmitter (chemical messenger) that supports communication between nerve cells.
Both the U.S. Food and Drug Administration (FDA) and the European Commission (EC) approved Fintepla in 2020 to treat patients 2 and older.
The approval was based on positive safety and efficacy results from two randomized Phase 3 trials — ZX008-1501 (NCT02682927) and ZX008-1502 (NCT02826863) — as well as interim findings from an open-label extension study (NCT02823145) in 330 Dravet patients. The ZX008-1502 study is still recruiting eligible patients at clinical sites across Japan; more information about enrollment is available here.
The Phase 3 trials compared two dosages of Fintepla — 0.7 and 0.2 mg/kg/day — with a placebo in children ages 2 to 18. Treatment occurred over a 14-week period, including an initial two-week titration period to the final dosage.
The trials’ primary goal was to assess high dose Fintepla’s effectiveness to lower the frequency of participants’ convulsive seizures compared to placebo. Secondary goals included change in seizure frequency on the lower dose, as well as overall changes in seizure severity, and the safety and tolerability of Fintepla.
Results from both trials showed that, when given at its higher dose, Fintepla signicantly reduced the frequency of convulsive seizures in children and young adults whose seizures were not adequately controlled by existing medications, including Diacomit (stiripentol).
Importantly, these reductions were observed within three to four weeks of treatment, and remained stable over the 14- to 15-week treatment periods.
Results from the open-label extension study also showed that Fintepla provided a sustained and meaningful reduction in convulsive seizure frequency among young children with Dravet, with similar efficacy to that seen in older patient groups.
The most common side effects reported were low appetite, diarrhea, fever, fatigue, upper respiratory tract infection, lethargy, drowsiness, and bronchitis.
Because Fintepla’s active ingredient, fenfluramine, was removed from the market in 1997 after some patients experienced cardiac complications, its labeling includes a warning about these possible side effects.
No cardiovascular complications were reported during the trials, but these potential complications require patients to undergo periodic cardiac monitoring by echocardiogram before treatment, every six months during treatment, and three to six months after treatment.
In addition to Dravet, Fintepla is being evaluated for the treatment of seizures associated with other rare epilepsies, such as Lennox-Gastaut syndrome.
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