FDA issues complete response letter regarding the NDA for carisbamate
The U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the New Drug Application (NDA) for carisbamate, an anti-epileptic drug in development, announced Ortho-McNeil-Janssen Pharmaceuticals, Inc.
The NDA, filed in October 2008 by Johnson & Johnson Pharmaceutical Research and Development, L.L.C. (J&JPRD) on behalf of Ortho-McNeil-Janssen Pharmaceuticals, Inc. seeks approval to market carisbamate (COMFYDE(TM)) for the adjunctive treatment of partial onset seizures in patients 16 years of age and older.
The company is currently evaluating the FDA's complete response letter, and will respond to the agency's questions as quickly as possible.
About Partial Onset Seizures and Epilepsy
According to the Epilepsy Foundation, epilepsy is one of the most common disorders of the nervous system. It is defined by recurrent unprovoked seizures. It is categorized as "generalized" or "partial" depending on the location of the abnormal electrical activity in the brain that characterizes the disorder. Partial-onset seizures are common and are often difficult to treat. Partial-onset seizures are most often characterized by simple or complex repetitive movements, but virtually any sensory or emotional symptom can also occur as part of a partial seizure, including complex visual or auditory hallucinations. There are two categories of partial onset seizures: simple partial seizures (in which consciousness is retained), and complex partial seizures (in which consciousness is impaired or lost). Partial seizures can generalize and lead to tonic clonic seizures, during which the patient loses consciousness and is at risk for falling or injury.
Carisbamate has demonstrated anti-epileptic drug activity when given in addition to other AEDs in clinical trials. Although the precise mechanism of action remains to be elucidated, carisbamate modulates brain neuron activity and thereby reduces epileptic activity and seizures. Carisbamate has been studied in three placebo-controlled, double-blind clinical studies with most common adverse events of dizziness, headache, somnolence, nausea and fatigue.