The US Food and Drug Administration (FDA) has approved Sunovion Pharmaceuticals' (Sunovion) antiepileptic drug (AED) Aptiom (eslicarbazepine acetate) for the treatment of partial-onset seizures in patients with epilepsy.
According to the FDA, seizures can cause a wide range of symptoms, including repetitive limb movements, unusual behavior and generalized convulsions with loss of consciousness as well as have serious consequences, including injury and death.
Epilepsy Foundation chair of Professional Advisory Board and Mayo Clinic chair of Neurology Joseph Sirven said patients with partial-onset epilepsy often require adjunctive treatment to achieve better seizure control.
"APTIOM is an important new treatment option with a well-established safety profile for healthcare providers and people living with epilepsy," Sirven said.
The approval is based on three Phase III randomized, double-blind, placebo-controlled, safety and efficacy trials carried out in over 1,400 participants which showed Aptiom has significantly reduced the frequency of epileptic seizures compared with a placebo.
FDA's Division of Neurology Products acting director Eric Bastings said some patients with epilepsy do not achieve satisfactory seizure control from existing treatments.
"It is important we continue to make new treatment options available to patients," Bastings said.
Sunovion is a US-subsidiary of Japanese drugmaker Dainippon Sumitomo Pharma and it expects to introduce Aptiom in the US pharmacies in the second quarter of 2014.
According to the company, most common side effects in patients taking the drug include dizziness, somnolence, nausea, headache, diplopia, vomiting, fatigue, vertigo, ataxia, blurred vision and tremor.
The Centers for Disease Control and Prevention said, epilepsy is one of the most common neurological disorders and affects about 2.2 million people in the US, while partial-onset seizures are the most prevalent seizure type, which account for 60% of new epilepsy diagnoses.
