The FDA has expanded the use of Sunovion's anticonvulsant eslicarbazepine acetate (Aptiom) as monotherapy for partial-onset seizures.
The FDA has expanded the use of Sunovion’s anticonvulsant eslicarbazepine acetate (Aptiom) as monotherapy for partial-onset seizures.
Previously approved in 2013 as adjunctive therapy for partial-onset seizures, Aptiom is now the only once-daily, non-extended-release antiepileptic drug (AED) that can be used alone or in combination with other AEDs to treat partial-onset seizures.
This expanded indication was supported by 2 pivotal phase 3 clinical trials that demonstrated Aptiom’s effectiveness and safety within a daily dose range of 800 mg to 1600 mg.
“Prescribers now have greater flexibility to optimize clinical response and tolerability when using Aptiom to treat people with partial-onset seizures,” stated Antony Loebel, MD, executive vice president and chief medical officer of Sunovion.
John Stern, MD, director of the Epilepsy Clinical Program and professor in the UCLA Department of Neurology, noted that about one-third of the approximately 3 million epilepsy patients in the United States do not completely respond to current treatment approaches.
Aptiom is the newest addition to the dibenzazepine carboxamide class of AEDs.
Side effects associated with Aptiom include nervous system problems such as dizziness, sleepiness, and vision problems. The drug can also cause suicidal thoughts or actions, serious skin rash, low sodium levels in the blood, and liver problems, and it may decrease the effectiveness of birth control.