Lennox-Gastaut syndrome (LGS) is a rare, severe form of epilepsy that is often resistant to anti-seizure medications. This means that patients still experience epileptic episodes despite treatment. Because of this issue, the community is constantly searching for new treatment options. Now, they have one. The FDA recently approved FINTEPLA – also known under the generic name fenfluramine –  for LGS-associated seizures in patients two years of age and older.

About FDA Approval

This is not the first FDA approval that FINTEPLA has received. Back in June of 2020, this oral solution was approved for seizures associated with another epilepsy disorder, Dravet syndrome. So it makes sense that there have been continued efforts to develop and evaluate FINTEPLA for similar conditions. In addition to FDA approval, FINTEPLA also received pediatric exclusivity.

A phase 3 study – which was global, randomized, and placebo-controlled – supported this approval. 263 LGS patients were a daily dose of 0.7 mg/kg of FINTEPLA. The following results were produced:

• Monthly drop seizures were reduced by a median of 23.7% from baseline
  • This can be compared to a median reduction of 8.7% in the placebo group
• Of the patients receiving FINTEPLA, almost 1/4 saw a reduction in drop seizure frequency of greater than 50%
  • 18% saw a reduction between 50% and 75%
  • 6% saw a reduction greater than 75%
• Common adverse events (AEs) included:
  • Diarrhea
  • Vomiting
  • Fatigue
  • Somnolence
  • Decreased appetite

FINTEPLA’s ability to reduce the frequency of drop seizures – which are notoriously hard to treat and can cause injuries – is what makes it so exciting. Beyond this, it can also be added to a patient’s current anti-seizure medication regiment without any disruption.

This drug is available through the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) Program, which is a restricted distribution program. Want to learn more about this drug? Check out the source article.

About LGS

Lennox-Gastaut syndrome is a rare and severe form of epilepsy that accounts for five percent of childhood epilepsy cases. Symptoms tend to appear between the ages of two and six, with repetitive, frequent seizures being the major effect. Patients may experience absence, atonic, or tonic seizures, in addition to behavioral issues, learning and developmental delays, and injuries from falls.

Medical professionals are not always sure of the cause of LGS, but it is identifiable in some cases. Possible causes include premature birth, lack of oxygen at birth, low birth weight, severe brain infections, severe brain injury during birth or pregnancy, and issues with brain development during pregnancy. In terms of treatment, doctors will utilize anti-seizure medications, surgery to place a nerve stimulator, special diets, and corpus callosotomy surgery in severe cases.