FDA Approves Fycompa For Treatment Expansion

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.

Read the full release here.

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