J&JPRD Submitts Carisbamate NDA

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) has submitted a NDA to the FDA for carisbamate, an 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 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. entered into a license agreement to develop and commercialize carisbamate under which J&JPRD received global marketing rights. If approved, carisbamate will be marketed by Ortho-McNeil Neurologics under the brand name Comfyde.