The US subsidiary of Tokyo-based Eisai has announced that its epilepsy drug Fycompa (perampanel) will be available to eligible patients by prescription in the US, beginning 6 January.
Fycompa, an oral medication, is the first and only FDA-approved non-competitive AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) glutamate receptor antagonist.
It is offered as an adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalised seizures in patients with epilepsy age 12 years and older.
The drug is designated as a federally controlled substance (CIII) by the US Drug Enforcement Administration.
In October 2012, Fycompa received the FDA approval based on three Phase III studies (304, 305 and 306), which were multi-centre, randomised, double-blind, placebo-controlled, dose-escalation, parallel group studies, to evaluate the efficacy and safety of perampanel compared to placebo given as adjunctive therapy in patients age 12 and older with partial-onset seizures.
These studies reported that Fycompa significantly reduced seizure frequency in patients with partial-onset seizures with or without secondarily generalised seizures.
Eisai president and CEO Lonnel Coats said Fycompa offers patients and their physicians a new adjunctive treatment option.
"This is important because far too many patients with partial onset seizures continue to have seizures even while on medication," Coats said.
In three Phase III trials, the most frequently reported dose-related adverse reactions in patients receiving Fycompa 8mg or 12mg vs placebo included 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.
Eisai Product Creation Systems president for neuroscience and general medicine Dr Lynn Kramer said the company 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.
"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," Dr Kramer said.
Fycompa is currently approved in more than 30 countries; it will be supplied as 2mg, 4mg, 6mg, 8mg, 10mg and 12mg film-coated tablets.
Image: Head office of Eisai Co,Ltd. (Bunkyo-ku, Tokyo, Japan). Photo: KW at ja.wikipedia.