FDA approves Aptiom to treat seizures in adults

November 12, 2013

FDA approved antiepileptic drug eslicarbazepine acetate (Aptiom, Sunovion Pharmaceuticals) for use as adjunctive treatment of partial onset seizures, the most common type of seizure seen in people with epilepsy.

FDA approved antiepileptic drug eslicarbazepine acetate (Aptiom, Sunovion Pharmaceuticals) for use as adjunctive treatment of partial onset seizures, the most common type of seizure seen in people with epilepsy.

“The . . . approval of Aptiom as add-on therapy for seizures associated with epilepsy increases the number of treatment options that are available to patients and providers,” said Formulary advisor Abimbola Farinde, PharmD, MS, who serves on the faculty at Columbia Southern University, Orange Beach, Ala. “It can aid in the effective management of this brain disorder and potentially improve the quality of life of many Americans who suffer from this condition.”

Epilepsy is a brain disorder caused by abnormal or excessive activity in the brain’s nerve cells. Approximately 200,000 new cases of seizures and epilepsy occur in the United States each year. Seizures can cause a wide range of symptoms, including repetitive limb movements, unusual behavior and generalized convulsions with loss of consciousness. Seizures can have serious consequences, including injury and death. 

The approval of Aptiom is based on 3 large phase 3 randomized, double-blind, placebo-controlled, safety and efficacy trials, which included more than 1,400 people living with partial-onset seizures inadequately controlled by 1 to 3 concomitant AEDs (including carbamazepine, lamotrigine, valproic acid, and levetiracetam). In these global studies, treatment with Aptiom demonstrated statistically significant reductions in standardized seizure frequency versus placebo, and significantly more Aptiom treated patients experienced seizure frequency reduction of 50% or more from baseline (41% compared to 22% for placebo-treated patients). 

Dizziness, drowsiness, nausea, headache, double-vision, vomiting, fatigue and loss of coordination, were the most common side effects associated with Aptiom. These and other side effects and recommendations for monitoring are described in the drug label.

Like other antiepileptic drugs, Aptiom may cause suicidal thoughts or actions in a very small number of people. Patients should contact their healthcare professionals right away if they have thoughts about suicide or dying, new or worsened anxiety or depression, or other unusual changes in behavior or mood.

Aptiom is being approved with a Medication Guide that provides patients with important information about the medication that can help patients avoid serious adverse events. The guide will be distributed each time a patient fills their prescription.

“The FDA approval of Aptiom is an important step forward in providing new options to manage partial-onset seizures for people living with epilepsy and the physicians who treat them. Nearly one-third of people living with epilepsy are unable to control their seizures; therefore, there continues to be a need for new therapies,” said Fred Grossman, DO, senior vice rresident, clinical development and medical affairs, Sunovion Pharmaceuticals Inc. “In clinical trials, patients with partial-onset seizures who were uncontrolled on their current antiepileptic medication had significant reductions in seizure frequency when Aptiom was added. We believe Aptiom offers convenient, once-daily dosing and simple titration for people living with partial-onset seizures. Since Aptiom was not classified as a scheduled product, Sunovion expects Aptiom to be available in US pharmacies in the second quarter [April-June] of 2014.”