FDA approves oral suspension of Eisai’s Fycompa

SILVER SPRING, Md. — The Food and Drug Administration has approved Eisai’s Fycompa (perampanel) oral suspension, the company announced Monday. The oral suspension has been approved to treat partial-onset seizures with or without secondary generalized seizures, as well as for primary generalized tonic-clinic (PGTC) seizures in patients with epilepsy older than 12. 

 

“We are excited about the approval of FYCOMPA Oral Suspension, as it gives another option to patients with epilepsy who may have difficulty swallowing tablets or prefer liquids,” said Dr. Lynn Kramer, Eisai’s chief clinical officer and chief medical officer of its neurology business group. “The development of this new formulation underscores Eisai's commitment to advancing epilepsy care by making contributions to help address the diversified needs of epilepsy patients and their families.”

 

The new oral formulation is interchangeable with the company’s Fycompa tablets, and Eisai expects to make it available in June. The drug comes with a boxed warning for serious psychiatric and behavioral reactions.