FDA rejects application for new epilepsy drug

TITUSVILLE, N.J. A drug maker’s regulatory approval application for a new epilepsy drug has been rejected.

Johnson & Johnson announced last week that the Food and Drug Administration had delivered it a complete response letter regarding the drug Comfyde (carisbamate). A complete response letter means that the agency requires additional clinical data before it will approve a new drug or a new use for an existing drug.

J&J filed its application in October, seeking approval for the drug as a treatment for partial onset seizures in patients aged 16 and older.