WOODCLIFF LAKE, N.J., May 2, 2016 /PRNewswire/ -- Eisai Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved FYCOMPA® (perampanel) CIII Oral Suspension as adjunctive therapy for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures, and primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy 12 years of age and older. The oral suspension formulation is a bioequivalent, interchangeable alternative to the FYCOMPA tablet formulation, and is expected to be available to patients in June 2016. Please see Important Safety Information, including Boxed WARNING for Serious Psychiatric and Behavioral Reactions, below.
"We are excited about the approval of FYCOMPA Oral Suspension, as it gives another option to patients with epilepsy who may have difficulty swallowing tablets or prefer liquids," said Lynn Kramer, M.D., Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai. "The development of this new formulation underscores Eisai's commitment to advancing epilepsy care by making contributions to help address the diversified needs of epilepsy patients and their families."
The approval of FYCOMPA Oral Suspension was based on a bioequivalence (BE) study that demonstrated BE between a single dose of perampanel oral suspension and a single dose of perampanel tablet, when administered under fasted conditions in healthy subjects.
FYCOMPA (perampanel) is indicated as adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures and primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older.
FYCOMPA is an oral medication and the first and only FDA-approved non-competitive AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) receptor antagonist. The precise mechanism by which FYCOMPA exerts its antiepileptic effects in humans has not been fully elucidated.
FYCOMPA is supplied as 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg film-coated tablets, and now in an oral suspension formulation. FYCOMPA has been designated by the U.S. Drug Enforcement Administration as a federally-controlled substance (CIII).
FYCOMPA, approved in 43 countries, was discovered and developed by Eisai. Over 60,000 patients globally have been treated with FYCOMPA.
To assist patients with access to their medication, Eisai offers eligible patients a FYCOMPA Savings Card.* Patients can register now at Fycompa.com to activate their savings card, if their doctor has already given them one, or download a card and print it at home.
*Restrictions apply. Not available to patients enrolled in federal or state healthcare program, including Medicare, Medicaid, Medigap, VA, DoD or TRICARE.
Please refer to complete Eligibility Criteria.
Please visit Fycompa.com to learn more about the treatment.
Important Safety Information
FYCOMPA may cause: new or worse aggressive behavior, homicidal thoughts or threats, hostility, anger, anxiety, irritability, being suspicious or distrustful (believing things that are not true), and other unusual or extreme changes in behavior or mood. Before taking FYCOMPA, patients should tell their healthcare provider if they have or had mental problems, aggression or hostile behavior.
Patients, their caregivers, and families should monitor for these changes and call their healthcare provider right away if they have any new or worsening mental problems while taking FYCOMPA. The combination of alcohol and FYCOMPA significantly worsened mood and increased anger. Patients taking FYCOMPA should avoid the use of alcohol.
Antiepileptic drugs, including FYCOMPA, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Patients should call their healthcare providers right away if they have any of the following symptoms, especially if they are new, worse, or worrisome: thoughts about suicide or dying, thoughts of self-harm, attempt to commit suicide, new or worse depression, new or worse anxiety, feeling agitated or restless, panic attacks, trouble sleeping (insomnia), new or worse irritability, acting aggressive, being angry or violent, acting on dangerous impulses, an extreme increase in activity and talking (mania), and other unusual changes in behavior or mood.
Patients may have problems walking normally if they are unsteady because they feel dizzy. These symptoms may increase when their dose of FYCOMPA is increased. A patient's risk of feeling dizzy and having problems walking normally may be higher if they are elderly. FYCOMPA may make patients feel sleepy or tired. Patients should not drive, operate heavy machinery, or do other dangerous activities until they know how FYCOMPA affects them. A patient's risk of feeling sleepy and tired may be higher if they are elderly.
Taking FYCOMPA may increase a patient's chance of falling. These falls can cause serious injuries. A patient's risk of falling may be higher if they are elderly.
Patients must not stop FYCOMPA without first talking to their healthcare provider. Stopping FYCOMPA suddenly can cause serious problems and can cause patients to have seizures more often.
The most common side effects seen in patients receiving FYCOMPA were dizziness, sleepiness, headache, tiredness, irritability, falls, nausea, problems with muscle coordination, problems walking normally, vertigo, and weight gain. Tell your healthcare provider about any side effect that bothers you or does not go away.
Taking FYCOMPA with certain other medicines can cause side effects or reduce either drug's benefit. These other medicines include: birth control, carbamazepine, phenytoin, oxcarbazepine, rifampin, and St. John's wort.
Before taking FYCOMPA, patients should tell their healthcare provider if they drink alcohol. Patients should not drink alcohol or take other medicines that make them sleepy or dizzy while taking FYCOMPA until they talk to their healthcare provider. FYCOMPA taken with alcohol or medicines that cause sleepiness or dizziness may make their sleepiness or dizziness worse.
Before taking FYCOMPA, patients should tell their healthcare provider if they are pregnant or plan to become pregnant while taking FYCOMPA. It is not known if FYCOMPA will harm your unborn baby. If a patient becomes pregnant while taking FYCOMPA, they should talk to their healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry (1-888-233-2334).
Before taking FYCOMPA, patients should tell their healthcare provider if they are breastfeeding or plan to breastfeed. Patients should talk to their healthcare provider about the best way to feed their baby if they take FYCOMPA. Patients should not take FYCOMPA if they breastfeed.
Before taking FYCOMPA, patients should tell their healthcare provider if they have liver or kidney problems. They should not take FYCOMPA if they have severe kidney or liver problems.
FYCOMPA is a controlled substance (CIII) because it can be abused or lead to drug dependence. Before taking FYCOMPA, patients should tell their healthcare provider if they have abused prescription medicines, street drugs, or alcohol in the past. Patients should keep their FYCOMPA in a safe place to protect it from theft and should never give it to anyone else because it may harm them. Selling or giving away FYCOMPA is against the law.
Please see Full Prescribing Information.
Epilepsy is a medical condition that produces seizures affecting a variety of mental and physical functions. According to the Institute of Medicine, epilepsy is one of the most common neurological disorders, which affects 2.9 million people in the United States. Partial-onset seizures are the most common type of seizure seen in people with epilepsy, accounting for 60 percent of all seizures. Generalized seizures account for approximately 40 percent of all epilepsy, with PGTC seizures being one of the most common and severe forms of generalized seizures.
About Eisai Inc.
At Eisai Inc., human health care is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to discover and develop innovative therapies to help address unmet medical needs.
Eisai is a fully integrated pharmaceutical business that operates in two global business groups: oncology and neurology (dementia-related diseases and neurodegenerative diseases). Each group functions as an end-to-end global business with discovery, development, manufacturing and marketing capabilities. Our U.S. headquarters, commercial and clinical development organizations are located in New Jersey; our discovery labs are in Massachusetts and Pennsylvania; and our global demand chain organization resides in Maryland and North Carolina. To learn more about Eisai Inc., please visit us at www.eisai.com/US.
SOURCE Eisai Inc.
Type Press Release
Date Released May 02, 2016