Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Submits New Drug Application to FDA for Carisbamate; Seeks Approval for Use in Epilepsy as Adjunctive Treatment in Partial Onset Seizures
Raritan, NJ . - Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced today that it has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for carisbamate, a new investigational compound for the adjunctive treatment of partial onset seizures in patients 16 years of age and older.
The filing is supported by data from three placebo-controlled clinical trials in patients with epilepsy. Results from the first study were presented at the Ninth EILAT Conference on Antiepileptic Drugs in June and results from two additional studies will be presented at the annual meeting of the American Epilepsy Society later this year.
In 1999, J&JPRD and SK Holdings Co., Ltd. (SK) entered into a license agreement to develop and commercialize carisbamate. J&JPRD received global marketing rights for the compound. If approved by the FDA, carisbamate will be marketed by Ortho-McNeil Neurologics, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. Carisbamate has received provisional approval by the FDA to be marketed under the brand name of COMFYDE(TM).
About Partial Onset Seizures and Epilepsy
Epilepsy is one of the most common disorders of the nervous system, defined by recurrent unprovoked seizures. It is categorized as “primary generalized” or “partial onset” depending on the specific location of the abnormal electrical activity in the brain that typically characterizes the disorder. Partial-onset seizures are the most common type, and are generally more difficult to treat. Virtually any movement, sensory, or emotional symptom can 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.
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