FDA Approves New Treatment for Seizures Associated with Dravet Syndrome

The US Food and Drug Administration (FDA) approved Diacomit (stiripentol) for the treatment of seizures associated with Dravet syndrome, a rare form of epilepsy.

Diacomit is indicated for use in patients 2 years of age and older taking clobazam. There are no clinical data to support the use of DIACOMIT as monotherapy in Dravet syndrome.

Dravet syndrome is a rare genetic condition that usually appears during the first year of life with prolonged fever-related seizures (febrile seizures). Later, other types of seizures typically appear, including myoclonic seizures (involuntary, irregularly repetitive muscle jerks). Additionally, status epilepticus, a potentially life-threatening state of continuous seizure activity requiring emergency medical care, may occur. Children with Dravet syndrome typically experience poor development of language and motor skills, hyperactivity, and difficulty relating to others.

The most common side effects reported with Diacomit are somnolence (sleepiness and drowsiness), decreased appetite, agitation, ataxia (impaired coordination and balance), weight loss, hypotonia (low muscle tone), nausea, tremor, dysarthria (difficulty speaking words; difficulty forming words during speech), and insomnia.

Diacomit must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks. As is true for many other drugs that treat epilepsy, the most serious risks include thoughts about suicide, attempts to commit suicide, feelings of agitation, new or worsening depression, aggression, and panic attacks.

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