October 27, 2008
Johnson & Johnson Files New Drug Application for Seizure Drug
Johnson & Johnson Pharmaceutical Research & Development, a subsidiary of Johnson & Johnson, has submitted a new drug application to the 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. Previously, Johnson & Johnson Pharmaceutical Research & Development (J&JPRD) and SK Holdings have previously entered into a license agreement to develop and commercialize carisbamate.
J&JPRD has 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. Carisbamate has received provisional approval by the FDA to be marketed under the brand name of Comfyde.