Antiepileptic approved in an injectable formulation
UCBAntiepileptic approved in an injectable formulation
This antiepileptic is hypothesized to exert its effect by selectively preventing hypersynchronization of epileptiform burst firing and propagation of seizure activity. Levetiracetam injection was approved on July 31, 2006, as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. The formulation is an alternative for patients when oral administration is temporarily not feasible.
Efficacy. The efficacy of levetiracetam as adjunctive therapy for adults with epilepsy was assessed in 3 multicenter, randomized, double-blind, placebo-controlled clinical studies in patients who had refractory partial onset seizures with or without secondary generalization. Patients in all 3 studies (N=904) were randomized to placebo or 1,000, 2,000, or 3,000 mg/d of levetiracetam in the tablet formulation. Enrollees in Studies 1 and 2 had refractory partial onset seizures for at least 2 years and had taken 2 or more classical antiepileptic drugs (AEDs). Enrollees in Study 3 had refractory partial onset seizures for at least 1 year and had taken 1 classical AED. In Study 1, levetiracetam 1,000 mg/d demonstrated a 26.1% reduction in partial seizure frequency over placebo, while the 3,000 mg/d dosing regimen demonstrated a 30.1% reduction (P<.001). In Study 2, levetiracetam 1,000 mg/d demonstrated a 17.1% reduction in partial seizure frequency over placebo, while the 2,000 mg/d dosing regimen demonstrated a 21.4% reduction (P#.001). In Study 3, levetiracetam 3,000 mg/d demonstrated a 23.0% reduction in partial seizure frequency over placebo (P<.001).
Dosing. The recommended initial dose of levetiracetam injection is 1,000 mg/d, given as 2 doses of 500 mg. Additional dosing increments may be given (1,000 mg/d additional every 2 weeks) to a maximum recommended dose of 3,000 mg/d.