The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application for perampanel (Fycompa; Eisai Inc) CIII as monotherapy to treat partial-onset seizures (POS) with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older, the company has announced.
“This approval is good news for the epilepsy community because it means that more physicians and patients will have access to a single agent option for [POS],” Jacqueline A. French, MD, professor of neurology in the Epilepsy Division at New York University Langone Medical Center, and director of the Epilepsy Study Consortium, a nonprofit organization devoted to speeding therapies through development and into the clinic, said in a press release.
Fycompa is the first antiepileptic drug approved by the FDA following the pathway outlined in the agency’s September 13, 2016, General Advice Letter to antiepileptic drug New Drug Application holders.
According to that letter, “it is acceptable to extrapolate the efficacy and safety of drugs approved as adjunctive therapy for the treatment of [POS] to their use as monotherapy for the treatment of POS.”
Quicker Access
To date, conducting clinical trials with single agents in epilepsy has been problematic, said Dr French. “Now, with this change in the regulatory pathway, we have a safe and efficient process for quicker access to single agent therapies for [POS].”
In addition to the new monotherapy use in POS, Fycompa is approved for adjunctive use for POS and primary generalized tonic-clonic seizures in patients with epilepsy aged 12 years and older.
The approval for Fycompa monotherapy use was extrapolated on the basis of comparable exposures to those obtained with adjunctive use in clinical trials for the treatment of POS.
In the three initial adjunctive pivotal clinical trials in patients with POS, results showed improvement in seizure control in patients taking Fycompa compared with those taking placebo.
Fycompa was initially approved for adjunctive use in POS in 2012 and has been approved in 55 countries worldwide. To date, more than 100,000 patients have been treated with this agent, according to background information provided by the company. An oral suspension formulation was also approved last year.
Inadequate Control
About a third of people with epilepsy have seizures that are not adequately controlled, commented Robert Wechsler, MD, PhD, medical director, Idaho Comprehensive Epilepsy Center in Boise, in the press release.
“Having a new monotherapy option for [POS] that is once-a-day gives physicians and patients an effective treatment option that has the potential to make a difference in patients’ lives.”
The company “is proud” to be the first to receive approval for monotherapy use in POS after announcement of a new regulatory pathway, commented Lynn Kramer, MD, chief clinical officer and chief medical officer, Neurology Business Group, Eisai.
“This effort is consistent with Eisai’s broader mission of addressing the unmet needs of patients and making sure our therapies are available to those who need them in a timely manner.”
Perampanel is a noncompetitive AMPA (α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) receptor antagonist. The precise mechanism by which it exerts its antiepileptic effects in humans is not fully understood.
Controlled Substance
Because it can be abused or lead to drug dependence, perampanel has been designated by the US Drug Enforcement Administration as a federally controlled substance.
According to information about the product on the Eisai website, perampanel may cause new or worse aggressive behavior, homicidal thoughts or threats, hostility, anger, anxiety, irritability, being suspicious or distrustful, and other unusual or extreme changes in behavior or mood. The combination of alcohol and perampanel may significantly worsen mood and increase anger.
Antiepileptic drugs, including perampanel, may cause suicidal thoughts or actions in about 1 in 500 people.
Along with dizziness, sleepiness, falls, tiredness, and problems walking normally, the most common adverse effects seen in patients receiving perampanel include headache, irritability, nausea, problems with muscle coordination, vertigo, and weight gain.
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