Introducing a New Drug and a New Device
November is National Epilepsy Awareness Month, and it has been a banner month for people with epilepsy. The US Food and Drug Administration (FDA) approved 2 new therapeutic options: a new drug, eslicarbazepine acetate; and a new device, the NeuroPace RNS® (NeuroPace; Mountain View, California) system.
Eslicarbazepine acetate was approved by the European Medicines Agency in 2009 and is known as Zebinix® in Europe. In the United States, it will be marketed as Aptiom® by Sunovion Pharmaceuticals, Inc. Aptiom is indicated for adjunctive treatment of partial seizures in adults.
An implantable device, the NeuroPace RNS system received FDA approval for adults with intractable partial-onset seizures. The NeuroPace RNS system detects abnormal electrical activity and responds with electrical stimulation to prevent seizures.
This article focuses on eslicarbazepine acetate, with more on the NeuroPace RNS system next month.