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The Food and Drug Administration added another arrow to the quiver of epilepsy specialists on Oct. 22 by approving perampanel for the treatment of partial onset seizures in patients with epilepsy aged 12 years or older.
Perampanel, which will be marketed by Eisai Inc. under the brand name Fycompa, was the first antiepileptic drug (AED) to be submitted to the agency on the basis of an excitation mechanism rather than membrane inhibition or stabilization, according to Dr. Jacqueline French of New York University, who was an investigator in clinical studies of the drug. The AED is a highly selective, noncompetitive, alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) receptor antagonist.
"Some people with epilepsy do not achieve satisfactory seizure control from treatments they are currently using," said Dr. Russell Katz, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. "It is important to have a variety of treatment options available for patients with epilepsy."
Three phase III trials of the drug have reported 28-day reductions in seizure frequency relative to placebo in patients who were taking one to three other AEDs.
The drug’s label will include a boxed warning about the risk of serious (and in some cases life-threatening) neuropsychiatric events that were recorded during clinical trials, including irritability, aggression, anger, anxiety, paranoia, euphoric mood, agitation, and mental status changes. The agency noted that health care professionals should "closely monitor patients during the titration period when higher doses are used."
The drug is already approved in the European Union.
The Food and Drug Administration added another arrow to the quiver of epilepsy specialists on Oct. 22 by approving perampanel for the treatment of partial onset seizures in patients with epilepsy aged 12 years or older.
Perampanel, which will be marketed by Eisai Inc. under the brand name Fycompa, was the first antiepileptic drug (AED) to be submitted to the agency on the basis of an excitation mechanism rather than membrane inhibition or stabilization, according to Dr. Jacqueline French of New York University, who was an investigator in clinical studies of the drug. The AED is a highly selective, noncompetitive, alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) receptor antagonist.
"Some people with epilepsy do not achieve satisfactory seizure control from treatments they are currently using," said Dr. Russell Katz, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. "It is important to have a variety of treatment options available for patients with epilepsy."
Three phase III trials of the drug have reported 28-day reductions in seizure frequency relative to placebo in patients who were taking one to three other AEDs.
The drug’s label will include a boxed warning about the risk of serious (and in some cases life-threatening) neuropsychiatric events that were recorded during clinical trials, including irritability, aggression, anger, anxiety, paranoia, euphoric mood, agitation, and mental status changes. The agency noted that health care professionals should "closely monitor patients during the titration period when higher doses are used."
The drug is already approved in the European Union.
The Food and Drug Administration added another arrow to the quiver of epilepsy specialists on Oct. 22 by approving perampanel for the treatment of partial onset seizures in patients with epilepsy aged 12 years or older.
Perampanel, which will be marketed by Eisai Inc. under the brand name Fycompa, was the first antiepileptic drug (AED) to be submitted to the agency on the basis of an excitation mechanism rather than membrane inhibition or stabilization, according to Dr. Jacqueline French of New York University, who was an investigator in clinical studies of the drug. The AED is a highly selective, noncompetitive, alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) receptor antagonist.
"Some people with epilepsy do not achieve satisfactory seizure control from treatments they are currently using," said Dr. Russell Katz, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. "It is important to have a variety of treatment options available for patients with epilepsy."
Three phase III trials of the drug have reported 28-day reductions in seizure frequency relative to placebo in patients who were taking one to three other AEDs.
The drug’s label will include a boxed warning about the risk of serious (and in some cases life-threatening) neuropsychiatric events that were recorded during clinical trials, including irritability, aggression, anger, anxiety, paranoia, euphoric mood, agitation, and mental status changes. The agency noted that health care professionals should "closely monitor patients during the titration period when higher doses are used."
The drug is already approved in the European Union.
