FDA Approved Drugs » 2012
Medical Areas: Neurology | Pediatrics/Neonatology | Family Medicine | Genetic Disease
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved October 2012
Treatment Area: partial-onset seizures with or without secondarily generalized seizures
Fycompa (perampanel) is a selective AMPA-type glutamate receptor antagonist. The AMPA receptor is widely present most excitatory neuronal synapses and plays a role in a large number of central nervous system diseases.
Fycompa is specifically indicated as adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy aged 12 years and older.
Fycompa is supplied as a tablet for oral administration. The recommended dose is a follows:In the absence of enzyme-inducing anti-epileptic drugs:The recommended starting dosage of Fycompa is 2 mg once daily taken orally at bedtime. Increase dosage by 2 mg per day increments no more frequently than every week to a dose of 4 mg to 8 mg once daily taken at bedtime. In elderly patients, dosage increases during titration are recommended no more frequently than every two weeks. The recommended maximum dose is 12 mg once daily.In the presence of enzyme-inducing anti-epileptic drugs:The recommended starting dosage of Fycompa in the presence of enzyme-inducing anti-epileptic drug, including phenytoin, carbamazepine, and oxcarbazepine, is 4 mg and patients should be monitored closely for
FDA ApprovalThe FDA approval of Fycompa was based on three randomized, double-blind, placebo-controlled, multicenter trials (Studies 1, 2, and 3) in 1,037 adults and adolescents aged 12 years and older. All trials had an initial 6-week baseline period, during which patients were required to have more than five seizures in order to be randomized. This was followed by a 19 week treatment period consisting of a 6 week titration phase and a 13 week maintenance phase. The median baseline seizure frequency ranged from 9.3 to 14.3 seizures per 28 days. The primary endpoint was the percent change in seizure frequency per 28 days during the treatment period as compared to the baseline period. A statistically significant decrease in seizure rate was observed at doses of 4 to 12 mg per day. Dose response was apparent at 4 to 8 mg with little additional reduction in frequency at 12 mg per day. For combined data, the percentages of patients with a 40 to <60% reduction in seizure frequency were 13.2%, 17.4%, 19.0%, and 15.8% for placebo, 4, 8, and 12 mg, respectively. The percentages of patients with a 50% or greater reduction in seizure frequency were 19.3%, 28.5%, 35.3%, 35.0% for placebo, 4, 8, and 12 mg, respectively.
Adverse events associated with the use of Fycompa may include, but are not limited to, the following:
Fycompa (perampanel) is a non-competitive antagonist of the ionotropic a-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) glutamate receptor on post-synaptic neurons. Glutamate is the primary excitatory neurotransmitter in the central nervous system and is implicated in a number of neurological disorders caused by neuronal over excitation.
Krauss GL, Perucca E, Ben-Menachem E, Kwan P, Shih JJ, Squillacote D, Yang H, Gee M, Zhu J, Laurenza A Perampanel, a selective, noncompetitive a-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor antagonist, as adjunctive therapy for refractory partial-onset seizures: Interim results from phase III, extension study 307. Epilepsia 2012 Aug 20. doi: 10.1111/j.1528-1167.2012.03648.x
French JA, Krauss GL, Steinhoff BJ, Squillacote D, Yang H, Kumar D, Laurenza A Evaluation of adjunctive perampanel in patients with refractory partial-onset seizures: Results of randomized global phase III study 305. Epilepsia 2012 Aug 20. doi: 10.1111/j.1528-1167.2012.03638.x
French JA, Krauss GL, Biton V, Squillacote D, Yang H, Laurenza A, Kumar D, Rogawski MA Adjunctive perampanel for refractory partial-onset seizures: randomized phase III study 304 Neurology 2012 Aug 7;79(6):589-96. doi: 10.1212/WNL.0b013e3182635735
Krauss GL, Serratosa JM, Villanueva V, Endziniene M, Hong Z, French J, Yang H, Squillacote D, Edwards HB, Zhu J, Laurenza A Randomized phase III study 306: adjunctive perampanel for refractory partial-onset seizures. Neurology 2012 May 1;78(18):1408-15
For additional information regarding Fycompa or partial seizures, please visit the Eisai web page.
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