Johnson & Johnson Pharmaceutical Research & Development, LLC (J&JPRD) announced that it has submitted a New Drug Application to the US 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.
Johnson & Johnson Pharmaceutical Research & Development, LLC (J&JPRD) is a subsidiary of Johnson & Johnson, the world's most broadly-based producer of health care products.