Fycompa was first approved by the FDA in October 2012 as an ancillary treatment for partial-onset seizures for patients over 12 years of age; with or without generalized seizures. It’s distribution began in Jauary 2014. On June 22, 2015 Eisai released a statement that the FDA expanded the approved use of Fycompa to include primary generalized tonic-clonic seizures.
The FDA based their expansion decision on the results of a placebo-controlled clinical study. The study showed a significant reduction in primary generalized tonic-clonic seizures in the Fycompa group. The most common side affects reported from the participants included; dizziness, fatigue, headache, somnolence and irritability.
Approximately 30% of Epilepsy patients have refractory/intractable seizures; meaning they are not responsive to medications. With generalized tonic-clonic seizures increasing the chances of SUDEP (sudden unexpected death in epilepsy) the success of this medication since it’s release shows promise.