WOODCLIFF LAKE, N.J., Sept. 14, 2015 /PRNewswire/ -- Eisai Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's New Drug Application (NDA) for FYCOMPA® (perampanel) CIII Oral Suspension 0.5 mg/mL for adjunctive therapy in 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.
Acceptance for the review of the new formulation for FYCOMPA indicates that the FDA has found the company's submission to be sufficiently complete to review. The NDA was submitted to the FDA on June 30, 2015.
"The acceptance for review of this NDA for FYCOMPA Oral Suspension is an important step toward expanding treatment options for patients with epilepsy who have difficulty, or prefer not to, swallow the current tablet formulation," said Lynn Kramer, M.D., FAAN, Chief Clinical Officer, President, Neuroscience & General Medicine Product Creation Unit, Eisai Product Creation Systems, Eisai Inc. "Eisai remains committed to advancing epilepsy care for patients as part of its corporate human health care (hhc) mission to help address unmet medical needs of epilepsy patients and their families."
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 is unknown.
FYCOMPA is supplied as 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg film-coated tablets. FYCOMPA has been designated by the U.S. Drug Enforcement Administration as a federally-controlled substance (CIII).
FYCOMPA, approved in over 40 countries and currently available in 22 countries, was discovered and developed by Eisai. Over 35,000 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
WARNING: SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS
Serious Psychiatric and Behavioral Reactions
In the partial- onset clinical trials, 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. Homicidal ideation and/or threat have also been reported post marketing in patients treated with FYCOMPA. 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. Similar serious psychiatric and behavioral events were observed in the primary generalized tonic-clonic seizure clinical trial.
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.
Dizziness and Gait Disturbance
FYCOMPA caused dose-related increases in events related to dizziness and disturbance in gait or coordination. Dizziness and vertigo were reported in 35% and 47% of patients in the partial-onset seizures clinical trials randomized to receive FYCOMPA at doses of 8 mg and 12 mg/day, respectively, compared to 10% of placebo- treated patients. Gait disturbance related events were reported in 12% and 16% of patients in the partial-onset seizures clinical trials randomized to receive FYCOMPA at doses of 8 mg and 12 mg/day, respectively, compared to 2% of placebo-treated patients. These adverse reactions occurred mostly during the titration phase. These adverse reactions were also observed in the primary generalized tonic-clonic seizure clinical trial.
Somnolence and Fatigue
FYCOMPA caused dose-dependent increases in somnolence and fatigue-related events. Somnolence was reported in 16% and 18% of patients in the partial-onset seizures trials randomized to receive FYCOMPA at doses of 8 mg and 12 mg/day, respectively, compared to 7% of placebo patients. Fatigue-related events were reported in 12% and 15% of patients in the partial-onset seizures trials randomized to receive FYCOMPA at doses of 8 mg and 12 mg/day, respectively, compared to 5% of placebo patients. These adverse reactions occurred mostly during the titration phase. These adverse reactions were also observed in the primary generalized tonic-clonic seizure clinical trial. Patients should be advised against engaging in hazardous activities requiring mental alertness, such as operating motor vehicles or dangerous machinery, until the effect of FYCOMPA is known.
Falls were reported in 5% and 10% of patients in the partial-onset seizures clinical trials randomized to receive FYCOMPA at doses of 8 mg and 12 mg/day, respectively, compared to 3% of placebo-treated patients.
Withdrawal of AEDs
A gradual withdrawal is generally recommended with antiepileptic drugs to minimize the potential of increased seizure frequency, but if withdrawal is a response to adverse events, prompt withdrawal can be considered.
Most Common Adverse Reactions
The most common adverse reactions (≥5% and ≥1% higher than placebo) include dizziness, somnolence, fatigue, irritability, falls, nausea, weight gain, vertigo, ataxia, headache, vomiting, contusion, abdominal pain, and anxiety.
FYCOMPA may decrease the efficacy of contraceptives containing levonorgestrel. Plasma levels of FYCOMPA were decreased when administered with carbamazepine, phenytoin, or oxcarbazepine. Concomitant use with strong CYP3A inducers such as St. John's wort or rifampin should be avoided. Multiple dosing of FYCOMPA 12 mg/day enhanced the effects of alcohol on vigilance and alertness, and increased levels of anger, confusion, and depression. These effects may also be seen when FYCOMPA is used in combination with other CNS depressants.
Pregnancy Category C and Lactation
FYCOMPA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Physicians are advised to recommend that pregnant patients taking FYCOMPA enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. Caution should be exercised when FYCOMPA is administered to a nursing woman.
Hepatic and Renal Impairment
Use in patients with severe hepatic or severe renal impairment is not recommended. Dosage adjustments are recommended in patients with mild or moderate hepatic impairment. Use with caution in patients with moderate renal impairment.
Drug Abuse and Dependence
FYCOMPA is a Schedule III controlled drug substance and has the potential to be abused or lead to drug dependence.
For more information about FYCOMPA, please see Full Prescribing Information.
Epilepsy affects 2.9 million people in the United States. One of the most common types of seizures seen in people with epilepsy are partial-onset seizures, accounting for 60% of all seizures. Generalized seizures account for approximately 40% of all epilepsy, and PGTC seizures are a common and severe form of generalized seizures that frequently lead to morbidity and mortality. In about 30% of patients with epilepsy, seizures may not be adequately controlled with treatment. Generalized tonic-clonic seizures can cause significant injury to patients from falling down suddenly and are the most important risk factor associated with sudden unexpected death in epilepsy (SUDEP), making them one of the most severe forms of epileptic seizures. (FYCOMPA is not indicated for the prevention of SUDEP).
About Eisai Inc.
At Eisai Inc., human health care (hhc) is our goal. We give our first thoughts to patients and their families. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., our passionate commitment to patient care is the driving force. We are a fully integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities. Our key areas of commercial focus include oncology and specialty care (Alzheimer's disease, epilepsy and metabolic disorders). To learn more about Eisai Inc., please visit us at www.eisai.com/US.
Eisai Inc. has affiliates that are part of a global product creation organization that includes R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as a global demand chain organization that includes manufacturing facilities in Maryland and North Carolina. Eisai's global areas of R&D focus include neuroscience; oncology; metabolic disorders; vascular, inflammatory and immunological reaction; and antibody-based programs.
SOURCE Eisai Inc.
Type Press Release
Date Released September 14, 2015