FDA Approves New Drug for Treatment of Seizures Associated With Dravet Syndrome

Officials with the FDA approved have approved stiripentol (Diacomit) for the treatment of seizures associated with Dravet syndrome, a rare form of epilepsy.¹ Stiripentol is indicated for use in patients 2 years of age and older who are taking clobazam.¹ There are no clinical data to support the use of stiripentol as monotherapy in Dravet syndrome, according to the FDA.

Dravet syndrome is a rare genetic condition that usually appears during the first year of life with prolonged fever-related seizures. Other types of seizures typically appear later, including myoclonic seizures. 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.¹

The most common adverse effects reported with stiripentol are sleepiness and drowsiness, decreased appetite, agitation, impaired coordination and balance, weight loss, low muscle tone, nausea, tremor, difficulty speaking words and difficulty forming words during speech, and insomnia.¹

Diacomit must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks.¹ The most serious risks include thoughts about suicide, attempts to commit suicide, feelings of agitation, new or worsening depression, aggression, and panic attacks.¹

In addition to stiripentol, the FDA approved in June a novel cannabinoid (CBD) treatment (Epidiolex) for Dravet syndrome, as well as Lennox-Gastaut syndrome.² That approval was the FDA's first for a drug utilized to treat Dravet syndrome, and the first in a new category of antiepileptic drugs. Epidiolex is a prescription formulation of highly-purified, plant-derived CBD, a cannabinoid lacking the high associated with marijuana.²

References

• FDA approves new treatment for seizures associated with Dravet syndrome - Drug Information Update. FDA Division of Drug Information. August 21, 2018.
• Barrett J. FDA Approves Groundbreaking Drug for Treating Rare, Severe Forms of Epilepsy. Pharmacy Times. https://www.pharmacytimes.com/news/fda-approves-groundbreaking-drug-for-treating-rare-severe-forms-of-epilepsy. Published June 25, 2018. Accessed August 21, 2018.