FDA Approves Antiseizure Drug for Treatment of Severe Form of Epilepsy
The US Food and Drug Administration (FDA) has approved Diacomit (stiripentol) for the treatment of seizures associated with Dravet syndrome, a rare form of epilepsy.
The medication is indicated for use in patients aged 2 years or older who are taking clobazam, a benzodiazepine used to treat seizures in epilepsy. No clinical data support the use of stiripentol as monotherapy in Dravet syndrome, according to the FDA.
Dravet syndrome is a rare genetic condition that usually appears in the first year of life. It is characterized by prolonged febrile seizures that later are typically followed by other seizure types such as myoclonic seizures, as well as the potential for status epilepticus. Children with Dravet syndrome typically experience poor development of language and motor skills, hyperactivity, and difficulty relating to others, the FDA said.
The most common adverse effects reported with stiripentol are somnolence, decreased appetite, agitation, ataxia, weight loss, hypotonia, nausea, tremor, dysarthria, and insomnia. Among the most serious risks are suicidality, suicide attempts, agitation, new or worsening depression, aggression, and panic attacks, the FDA said.
US Food and Drug Administration. Drugs@FDA: FDA Approved Drug Products. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206709. Accessed August 22, 2018.