Gastaut Syndrome – FDA Approved New Med for Lennox
The US Food and Drug Administration (FDA) has approved fenfluramine (Fintepla) oral solution, a Schedule IV controlled substance, for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children aged 2 years and older, the company has announced.
Fenfluramine is already approved in the US to treat seizures associated with Dravet syndrome. LGS is a relatively rare type of epilepsy that typically develops in early childhood and is often drug resistant.
Beyond seizures, LGS may contribute to intellectual disability and impairments in motor control, behavior, and cognition and is associated with an increased risk of sudden unexpected death in epilepsy.
The common adverse reactions in children treated with fenfluramine (incidence at least 10% and greater than placebo) were diarrhea, decreased appetite, fatigue, somnolence, and vomiting.
LGS is one of the most challenging epileptic encephalopathies to treat, and the vast majority of patients are not well controlled, despite a regimen of multiple antiepileptic drugs.
As a complementary therapy, fenfluramine offers a different mechanism of action and demonstrated ability to significantly reduce the number of seizures associated with a drop, a critical measure for managing this severe form of epilepsy.
The potential for fenfluramine to make a difference in the daily, horrific seizures we are dealing with in LGS cannot be understated. We are so grateful for the researchers who have worked so hard to help all of us suffering at the hands of LGS.
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