ABSTRACT

Felbamate (FBM), 2-phenyl-1,3-propanediol dicarbamate (molecular weight 283.24), was synthesized as part of a program that produced meprobamate, a sedative used for the treatment of anxiety. Acute neurotoxicity for FBM could not be demonstrated in either mice or rats at oral doses up to 1.5 g/kg. In general, FBM appears to have a wider spectrum of antiepileptic activity and a broader therapeutic index than phenytoin (PHT). FBM has an unusual drug interaction profile in humans: It increases PHT concentrations but decreases carbamazepine (CBZ) levels. A significant drug interaction between FBM and PHT was first observed during the initial pharmacokinetic study in patients. Initial evidence of clinical efficacy of FBM was found in a pharmacokinetic study using doses of up to 1600 mg/day. Definite neurotoxicity of FBM has not been observed in patients independent of PHT or CBZ. The major symptoms reported with FBM have been nausea, weight loss, and insomnia.