Eisai announced that the FDA has accepted for review the company's New Drug Application (NDA) for FYCOMPA® (perampanel) CIII Oral Suspension 0.5 mg/mL for adjunctive therapy in the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures and primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy 12 years of age and older.
Acceptance for the review of the new formulation for FYCOMPA indicates that the FDA has found the company's submission to be sufficiently complete to review. The NDA was submitted to the FDA on June 30, 2015.
"The acceptance for review of this NDA for FYCOMPA Oral Suspension is an important step toward expanding treatment options for patients with epilepsy who have difficulty, or prefer not to, swallow the current tablet formulation," said Lynn Kramer, M.D., FAAN, Chief Clinical Officer, President, Neuroscience & General Medicine Product Creation Unit, Eisai Product Creation Systems, Eisai Inc. "Eisai remains committed to advancing epilepsy care for patients as part of its corporate human health care (hhc) mission to help address unmet medical needs of epilepsy patients and their families."