Eisai Inc. will be making availability of FYCOMPA (perampanel) CIII to eligible patients by prescription in the US from January 6, 2014. FYCOMPA is an adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy age 12 years and older. FYCOMPA is the first non-competitive AMPA glutamate receptor antagonist to be approved by the FDA.
“FYCOMPA offers patients and their physicians a new adjunctive treatment option,” said Lonnel Coats, president and chief executive officer, Eisai Inc. “This is important because far too many patients with partial onset seizures continue to have seizures even while on medication.”
FYCOMPA was approved by the FDA in October 2012, primarily based on three phase III studies (304, 305 and 306). These multi-centre, randomized, double-blind, placebo-controlled, parallel group studies evaluated the efficacy and safety of FYCOMPA compared to placebo given as adjunctive therapy in patients age 12 and older with partial-onset seizures. The studies demonstrated that FYCOMPA significantly reduced seizure frequency in patients with partial-onset seizures with or without secondarily generalized seizures.
In the three clinical studies, the most common adverse events (greater than or equal to four per cent and greater than placebo) in patients treated with FYCOMPA eight or 12 mg were dizziness, sleepiness, tiredness, irritability, falls, nausea, problems with muscle coordination, problems walking normally, vertigo and weight gain. Serious or life-threatening psychiatric (mental) and behavioral problems were also seen more frequently in patients treated with FYCOMPA.
“We found that these phase III studies showed a significant reduction in the number of partial-onset seizures in patients that had FYCOMPA added to their treatment regimen,” said Lynn Kramer, MD, FAAN, president, Neuroscience & General Medicine, Eisai Product Creation Systems. “The availability of FYCOMPA gives physicians an important new adjunctive treatment option for the care of those patients whose seizures are not controlled by their current medication.”
FYCOMPA has been designated by the US Drug Enforcement Administration as a federally controlled substance (CIII). FYCOMPA will be supplied as 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg film-coated tablets.
Epilepsy is a therapeutic area of focus for Eisai. The company continues to make further contributions to help address the diversified needs of epilepsy patients and their families as part of its corporate human health care (hhc) mission.
Eisai Inc. aims at human health care and key areas of commercial focus includes oncology and specialty care (Alzheimer’s disease, epilepsy and metabolic disorders).