FYCOMPA is the First and Only FDA-Approved Non-Competitive AMPA Glutamate Receptor Antagonist
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-center, 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 4 percent and greater than placebo) in patients treated with FYCOMPA 8 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. These reactions are described in the Boxed WARNING bolded below and the Important Safety Information.
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 U.S. Drug Enforcement Administration as a federally controlled substance (CIII).
Important Safety Information
WARNING: SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS
Serious Psychiatric and Behavioral Reactions Hostility- and aggression-related adverse reactions occurred in 12% and 20% of clinical trial patients randomized to receive FYCOMPA at doses of 8 mg and 12 mg/day, respectively, compared to 6% of patients in the placebo group. These effects were dose-related and generally appeared within the first 6 weeks of treatment, although new events continued to be observed through more than 37 weeks. These effects in FYCOMPA-treated patients led to dose reduction, interruption, and discontinuation more frequently than placebo-treated patients. The combination of alcohol and FYCOMPA significantly worsened mood and increased anger. Patients taking FYCOMPA should avoid the use of alcohol. Patients, their caregivers, and families should be informed that FYCOMPA may increase the risk of psychiatric events. Patients should be monitored during treatment and for at least one month after the last dose of FYCOMPA, and especially when taking higher doses and during the initial few weeks of drug therapy (titration period) or at other times of dose increases.
Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including FYCOMPA, increase the risk of suicidal thoughts or behavior in patients. Anyone considering prescribing FYCOMPA or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Patients, their caregivers, and families should be informed of the risk and advised to monitor and immediately report the emergence or worsening of depression, suicidal thoughts or behavior, thoughts about self-harm, and/or any unusual changes in mood or behavior. Should suicidal thoughts or behavior emerge during treatment, consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.
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Eisai Announces U.S. Availability of FYCOMPA(TM) (perampanel) CIII an Adjunctive Treatment for Partial-Onset Seizures ...