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FDA Approves Perampanel for Tonic-Clonic Seizures

Epilepsy drug previously approved for partial-onset seizures

Indications: Perampanel (Fycompa), a non-competitive AMPA glutamate receptor antagonist, is indicated as adjunctive therapy for the treatment of partial onset-seizures with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older and primary generalized tonic-clonic seizures in patients with epilepsy 12 years and older.

Dosing: Starting dose is 2 mg once daily at bedtime, increasing by 2 mg once a day a weekly intervals. The recommended maintenance dose is 8 to 12 mg daily for partial-onset seizures and 8 mg daily for tonic-clonic seizures.

Pharmacokinetics: Perampanel is rapidly absorbed following oral administration, with median peak plasma concentrations ranging from 0.5 to 2.5 hours. It is metabolized through CYP pathways and eliminated primarily through feces and urine, with a half-life of 105 hours on average.

Side Effects/Risks: Serious or life-threatening psychiatric and behavioral adverse reactions including aggression, hospitality, irritability, anger, and homicidal ideation and threats have been reported. Patients should be monitored for any changes in mood, and the drug should be reduced or discontinued in the presence of symptoms.

Source: Highlights of prescribing information: Fycompa. FDA website. http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202834s005lbl.pdf. Revised June 2015. Accessed July 9, 2015.