Catalyst Pharmaceuticals, Inc. (“Catalyst”) (Nasdaq: CPRX) today announced that four abstracts highlighting FYCOMPA® (perampanel) CIII have been published and will be presented at the upcoming AAN 2023 Annual Meeting taking place in Boston, MA and virtually on April 22-27, 2023.
CORAL GABLES, Fla., April 20, 2023 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (“Catalyst”) (Nasdaq: CPRX), a commercial-stage, patient-centric biopharmaceutical company focused on in-licensing, developing and commercializing novel high-quality medicines for patients living with rare diseases, today announced that four abstracts highlighting FYCOMPA® (perampanel) CIII have been published and will be presented at the upcoming AAN 2023 Annual Meeting taking place in Boston, MA and virtually on April 22-27, 2023. These are encore presentations by Eisai Co., Ltd. (“Eisai”), who holds the rights to FYCOMPA in countries and regions outside the U.S.
FYCOMPA is indicated in patients with epilepsy aged four years and older for partial-onset seizures (POS) with or without secondarily generalized seizures and adjunctive therapy for patients aged 12 years and older for primary generalized tonic-clonic (“PGTC”) seizures.
The accepted and published abstracts detail the results from four independent clinical studies, further documenting the uses of perampanel in both focal and generalized epilepsy across a diverse range of patients, including those with a history of psychiatric and behavioral events, underage patients, and patients with seizures linked to Lennox-Gastaut Syndrome (“LGS”).
“We are very pleased to report that abstracts from four studies evaluating perampanel have been accepted for presentation at the upcoming AAN 2023 Annual Meeting,” said Gary Ingenito, MD, PhD, Chief Medical and Regulatory Officer of Catalyst. “Findings from these studies provide further evidence of the benefits of perampanel in the treatment of seizure disorders.”
Abstract Details:
Abstract Title:ELEVATE Study 410: Assessment of Cognition (EpiTrack®) Following Perampanel (Monotherapy/First Adjunctive) in Patients with Epilepsy and a History of Psychiatric/Behavioral Events
Authors: Vineet Punia, Omar Samad, Stella Ngo, Dinesh Kumar, Manoj Malhotra
Session Name: P11: Epilepsy/Clinical Neurophysiology (EEG): ASMs Clinical Trial 1
Topic: Epilepsy/Clinical Neurophysiology (EEG)
Program Number: P11.011
Author Institutions: Charles Shor Epilepsy Center, Cleveland Clinic, Cleveland, OH, USA; Eisai Inc., Nutley, NJ, USA; Formerly: Eisai Inc., Nutley, NJ, USA.
Abstract Title:Perampanel for Treatment of Focal and Generalized Epilepsy in Everyday Clinical Practice: Evidence from PERMIT and PROVE
Authors: Eugen Trinka, Robert Wechsler, Wendyl D’Souza, Tony Wu, Imad Najm, Leock Ngo, Rob McMurray, Vicente Villanueva
Session Name: P11: Epilepsy/Clinical Neurophysiology (EEG): ASMs Clinical Trial 1
Topic: Epilepsy/Clinical Neurophysiology (EEG)
Program Number: P11.008
Author Institutions: Department of Neurology, Christian-Doppler University Hospital, Paracelsus Medical University, Salzburg, Austria; Idaho Comprehensive Epilepsy Center, Boise, ID, USA; Department of Medicine, St Vincent’s Hospital Melbourne, The University of Melbourne, Victoria, Australia; Chang Gung Memorial Hospital Linkou Medical Center and Chang Gung University College of Medicine, Taoyuan, Taiwan; Cleveland Clinic Epilepsy Center, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA; Eisai Inc., Nutley, NJ, USA; Eisai Europe Ltd, Hatfield Hertfordshire, UK; Hospital Universitario y Politécnico La Fe, Valencia, Spain
Abstract Title: Long-Term Efficacy of Perampanel Monotherapy in Patients with Newly Diagnosed/Currently Untreated Recurrent Focal-Onset Seizures: FREEDOM Study 342 Extension Phase Analysis by Seizure Type
Authors: Sung Chul Lim, Anna Patten, Marcia Morita-Sherman, Stella Ngo, Takamichi Yamamoto
Session Name: P11: Epilepsy/Clinical Neurophysiology (EEG): ASMs Clinical Trial 1
Topic: Epilepsy/Clinical Neurophysiology (EEG)
Program Number: P11.005
Author Institution: The Catholic University of Korea, St. Vincent’s Hospital, Gyeonggi-do, Korea, Republic of Korea; Eisai Europe Ltd., Hatfield, Hertfordshire, UK; Eisai Inc., Nutley, NJ, USA; Seirei Hamamatsu General Hospital, Hamamatsu, Japan
Abstract Title: Early and Sustained Treatment Effect of Adjunctive Perampanel in Patients with Seizures Associated with Lennox-Gastaut Syndrome (LGS): A Post Hoc Analysis
Authors: Anna Patten, Marcia Morita-Sherman, Stella Ngo
Session Name: P11: Epilepsy/Clinical Neurophysiology (EEG): ASMs Clinical Trial 1
Topic: Epilepsy/Clinical Neurophysiology (EEG)
Program Number: P11.004
Author Institution: Eisai Europe Ltd., Hatfield, Hertfordshire, UK; Eisai Inc., Nutley, NJ, USA
About FYCOMPA®
FYCOMPA is a prescription medicine used in people with epilepsy aged 4 and older alone or with other medicines to treat partial-onset seizures with or without secondarily generalized seizures, and with other medicines to treat primary generalized tonic-clonic seizures for people with epilepsy aged 12 and older.
FYCOMPA, an oral medication, is a selective 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, and as a 0.5 mg/mL oral suspension formulation. FYCOMPA has been designated by the U.S. Drug Enforcement Administration as a federally-controlled substance (CIII). To date, FYCOMPA has been prescribed to over 500,000 patients globally.
For Full Prescribing Information, including Boxed WARNING for FYCOMPA®, please visit www.fycompa.com.
About Catalyst Pharmaceuticals
With exceptional patient focus, Catalyst is committed to developing and commercializing innovative first-in-class medicines that address rare neurological and epileptic diseases. Catalyst’s flagship U.S. commercial product is FIRDAPSE® (amifampridine) Tablets 10 mg, approved for the treatment of Lambert-Eaton myasthenic syndrome (“LEMS”) for adults and for children ages six to seventeen. In January 2023, Catalyst acquired the U.S. commercial rights to FYCOMPA® (perampanel) CIII, a prescription medicine approved in people with epilepsy aged four and older alone or with other medicines to treat partial-onset seizures with or without secondarily generalized seizures and with other medicines to treat primary generalized tonic-clonic seizures for people with epilepsy aged 12 and older. Further, Canada’s national healthcare regulatory agency, Health Canada, has approved the use of FIRDAPSE for the treatment of adult patients in Canada with LEMS.
For more information about Catalyst Pharmaceuticals, Inc., visit the Company’s website at: www.catalystpharma.com.
Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst’s actual results in future periods to differ materially from forecasted results. A number of factors, including those factors described in Catalyst’s Annual Report on Form 10-K for the fiscal year 2022 and its other filings with the U.S. Securities and Exchange Commission (“SEC”), could adversely affect Catalyst. Copies of Catalyst’s filings with the SEC are available from the SEC, may be found on Catalyst’s website, or may be obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date.
Important Safety Information: INDICATION FOR FYCOMPA
FYCOMPA® (perampanel) is indicated in patients with epilepsy aged 4 years and older for partial-onset seizures (POS) with or without secondarily generalized seizures and adjunctive therapy for patients aged 12 years and older for primary generalized tonic-clonic (PGTC) seizures.
IMPORTANT SAFETY INFORMATION FOR FYCOMPA
WARNING: SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS
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SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS
In the partial-onset seizures clinical trials, hostility- and aggression-related adverse reactions occurred in 12% and 20% of patients randomized to receive FYCOMPA at doses of 8 mg and 12 mg per 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. Homicidal ideation and/or threat have also been reported postmarketing in patients treated with FYCOMPA. The combination of alcohol and FYCOMPA significantly worsened mood and increased anger. 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 (PGTC) 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 and 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 seizure trials randomized to receive FYCOMPA at doses of 8 mg and 12 mg per 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 seizure clinical trials randomized to receive FYCOMPA at doses of 8 mg and 12 mg per 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 PGTC 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 seizure trials randomized to receive FYCOMPA at doses of 8 mg and 12 mg per day, respectively, compared to 7% of placebo-treated patients. Fatigue-related events were reported in 12% and 15% of patients in the partial-onset seizure trials randomized to receive FYCOMPA at doses of 8 mg and 12 mg per day, respectively, compared to 5% of placebo-treated patients. These adverse reactions occurred mostly during the titration phase. These adverse reactions were also observed in the PGTC 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. Patients should be carefully observed for signs of central nervous system (CNS) depression when FYCOMPA is used with other drugs with sedative properties because of potential additive effects.
FALLS
Falls were reported in 5% and 10% of patients in the partial-onset seizure clinical trials randomized to receive FYCOMPA at doses of 8 mg and 12 mg per day, respectively, compared to 3% of placebo-treated patients.
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS)
DRESS, also known as multiorgan hypersensitivity, has been reported in patients taking AEDs, including FYCOMPA. DRESS may be fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling, in association with other organ system involvement. If signs or symptoms are present, immediately evaluate the patient and discontinue FYCOMPA if an alternative etiology for signs or symptoms cannot be established.
WITHDRAWAL OF AEDs
A gradual withdrawal is generally recommended with AEDs 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 in patients aged 12 years and older receiving FYCOMPA (≥5% and ≥1% higher than placebo) include dizziness, somnolence, fatigue, irritability, falls, nausea, weight gain, vertigo, ataxia, headache, vomiting, contusion, abdominal pain, and anxiety. Adverse reactions in patients aged 4 to <12 years were generally similar to patients aged 12 years and older.
DRUG INTERACTIONS
FYCOMPA may decrease the efficacy of contraceptives containing levonorgestrel. Plasma levels of perampanel were decreased when administered with known moderate and strong CYP3A4 inducers, including, carbamazepine, phenytoin, or oxcarbazepine. Multiple dosing of FYCOMPA 12 mg per 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 AND LACTATION
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 pregnant or nursing women as there are no adequate data on the developmental risk associated with use in pregnant women, and no data on the presence of perampanel in human milk, the effects on the breastfed child, or the effects of the drug on milk production.
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 substance and has the potential to be abused and lead to drug dependence and withdrawal symptoms including anxiety, nervousness, irritability, fatigue, asthenia, mood swings, and insomnia.
Please see full Prescribing Information, including Boxed WARNING.
Source: Catalyst Pharmaceuticals, Inc.
Investor Contact Mary Coleman Catalyst Pharmaceuticals, Inc. (305) 420-3200 mcoleman@catalystpharma.com Media Contact David Schull Russo Partners (858) 717-2310 david.schull@russopartnersllc.com
