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 multiple abstracts highlighting FYCOMPA® (perampanel) CIII
will be presented at the upcoming 35th International Epilepsy
Congress (“IEC”) taking place on September 2 – 6, 2023 in Dublin,
Ireland. These are presentations by Eisai Co., Ltd. ("Eisai"),
which holds the rights to FYCOMPA in countries and regions outside
the U.S. Some abstracts will also be considered for publication in
Epilepsia following the IEC.
The accepted abstracts and presentations detail
the results from clinical and real-world studies, further
documenting the uses of perampanel in both focal and generalized
epilepsy across a diverse range of patients.
“These findings, which are being presented at
IEC, further validate and add to the growing body of evidence
supporting the benefits of perampanel in the treatment of seizure
disorders,” said Gary Ingenito, MD, PhD, Chief Medical and
Regulatory Officer of Catalyst. “We are pleased this investigative
work will be presented at such a prestigious forum.”
Details of the Accepted Abstracts are as
follows:
Title: Perampanel for Treatment
of Focal and Generalised Epilepsy in Everyday Clinical Practice:
Evidence from PERMIT 2Authors: Eugen Trinka,
Robert Wechsler, Wendyl D’Souza, Tony Wu, Imad Najm, Leock Ngo, Rob
McMurray, Vicente VillanuevaOral Presentation
number: 370Oral Presentation Session
Name: Drug Therapy 1Session: Sunday,
September 3, 2023, at 3:30 PM-4:30 PM BST(Eugen Trinka will present
for 10 minutes: 3:35 PM-3:45 PM)Presenter: Eugen
TrinkaLocation: Room Liffey B
Title: Study 603: Analysis of
Effectiveness and Safety of Perampanel in a Multicentre,
Retrospective Study in Patients from Korea with Focal-Onset
Seizures who Converted to MonotherapyAuthors: Sung
Chul Lim, Won Gu Lee, Dong Wook Kim, Kwang Ki Kim, Young-Min Shon,
Jihyun Park, Yoona Lee, Dae-Won SeoPoster number:
P048Digital Poster* Session and Rapid-Fire Presentation
Name: Drug Therapy 2Rapid Fire Presentation
(2-minute session):Time and Date: Sunday,
September 3, 2023, at 2:00 PM-2:30 PM
BSTPresenter: Sung Chul
LimLocation: Digital Poster Station: Level 3 Foyer
- Station C
Title: ELEVATE Study 410:
Assessment of Cognition (EpiTrack®) Following Perampanel
(Monotherapy/First Adjunctive) in Patients with Epilepsy and a
History of Psychiatric/Behavioral EventsAuthors:
Vineet Punia, Omar Samad, Stella Ngo, Dinesh
Kumar, Manoj Malhotra Poster
number: P149In-person & Digital Poster Session
Name: Drug TherapyPresentation:
Monday, September 4, 2023, at 1:30 PM-3:00 PM
BSTPresenter: Vineet
PuniaLocation: Poster Hall
Title: A Mirroring Clinical
Practice Study of Perampanel in Adults and Adolescents (AMPA):
Assessment of Impact of Perampanel on Seizure Control, Sleep and
Quality of LifeAuthors: Giovanni Assenza, Martina
Chiacchiaretta, Anna Patten, Ricardo Sáinz-Fuertes, Anna
GentilePoster number: P240Digital
Poster* (Available on the Congress app, online platform,
and digital poster terminals at the congress venue; Q&A chat
box function also available)
Title: Perampanel for Treatment
of Adolescent Patients (Aged ≥12 to <18 years): Real-World
Evidence from PERMIT 2Authors: Francisco José
Gil-López, Patricia Penovich, Rohit Shankar, Takamichi Yamamoto,
Omar Samad, Eugen Trinka, Vicente VillanuevaPoster
number: P364Digital Poster* (Available on
the Congress app, online platform, and digital poster terminals at
the congress venue; Q&A chat box function also available)
Title: Real-World Experience of
Treating Patients Aged <12 Years with
PerampanelAuthors: Adrián Garcia-Ron, Michael
Chez, Stéphane Auvin, Tony Wu, Wendyl D´Souza, Leock Y Ngo, Omar
Samad, Vicente VillanuevaPoster number:
P366Digital Poster* (Available on the Congress
app, online platform, and digital poster terminals at the congress
venue; Q&A chat box function also available)
Title: Perampanel for Treatment
of Focal and Generalised Epilepsy in Elderly Patients (Aged ≥65
years) in Clinical Practice: Evidence from PERMIT 2
Authors: Motoki Inaji, James Wheless, Rob
McMurray, Ricardo Sainz Fuertes, Alexandra Astner-Rohracher, Dong
Wook Kim, Eugen Trinka, Claudio Liguori, Vicente
VillanuevaPoster number: P367Digital
Poster* Session and Rapid-Fire Presentation Name:
Drug Therapy 2Rapid Fire Presentation (2-minute
session):Time and Date: Saturday,
September 2, 2023, at 2:00 PM-2:30 PM BSTLocation:
Digital Poster Station: Level 3 Foyer - Station C
Title: Perampanel for Treatment
of Asian Patients with Focal and Generalised Epilepsy in Clinical
Practice: Evidence from PERMIT 2Authors: Tony Wu,
James Wheless, Dong Wook Kim, Taoufik Alsaadi, Kousuke Kanemoto,
Yotin Chinvarun, Amitabh Dash, Vicente VillanuevaPoster
number: P371Digital Poster* (Available on
the Congress app, online platform, and digital poster terminals at
the congress venue; Q&A chat box function also available)
Title: Treatment of Adult
Epilepsy Patients with Perampanel: Evidence from Real-World
StudiesAuthors: Adam Strzelczyk, Eric Segal, Tim
Wehner, Leock Y Ngo, Ricardo Sainz Fuertes, Mar Carreño, Tony Wu,
Bernhard J. Steinhoff, Vicente VillanuevaPoster
number: P373Digital Poster* Session and Rapid-Fire
Presentation Name: Drug Therapy 4Rapid Fire
Presentation (2-minute session):Time and
Date: Monday, September 4, 2023, at 2:00 PM-2:30 PM
BSTLocation: Digital Poster Station: Level 3 Foyer
- Station C
Title: Study 512 Design:
Perampanel as First Adjunctive Therapy in Patients Aged ≥12 Years
with Focal-Onset Seizures or Generalised Tonic-Clonic Seizures
Associated With Genetic Generalised Epilepsy
Authors: Sergey Burd, Giovanni Assenza, Sofia
Quintas, Francisco José Gil López, Jan Wagner, Anna Patten, Ricardo
Sáinz-Fuertes, Stanislas Lagarde, Tobias Sejbaek, Pavel Vlasov,
Vadim Kharkovskiy, Anna LebedevaPoster number:
P505Digital Poster* (Available on the Congress
app, online platform, and digital poster terminals at the congress
venue; Q&A chat box function also available)
Title: PERPRISE (PERampanel in
patients with PRImary or SEcondarily generalised seizures): First
Interim Analysis of the Observational Study Assessing Perampanel as
the Only Adjunctive TherapyAuthors: Bernhard J
Steinhoff, Tobias Goldmann, Yaroslav WinterPoster
number: P534Digital Poster* (Available on
the Congress app, online platform, and digital poster terminals at
the congress venue; Q&A chat box function also available)
Title: Outcomes by Seizure Type
from A Mirroring Clinical Practice Study of Perampanel in Adults
and Adolescents (AMPA)Authors: Sara Casciato,
Martina Chiacchiaretta, Paola Mansi, Ricardo Sáinz-Fuertes, Anna
Patten, Anna GentilePoster number:
P529Digital Poster* (Available on the Congress
app, online platform, and digital poster terminals at the congress
venue; Q&A chat box function also available)
Title: ELEVATE Study 410:
Analysis of Time to First Seizure with Perampanel as Monotherapy or
First Adjunctive Therapy in Patients with Focal-Onset Seizures or
Generalised Tonic-Clonic SeizuresAuthors: Pavel
Klein, Omar Samad, Leock Y Ngo, Dinesh Kumar, Manoj
MalhotraPoster number: P540Digital
Poster* (Available on the Congress app, online platform,
and digital poster terminals at the congress venue; Q&A chat
box function also available)
About Catalyst
PharmaceuticalsWith 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. Finally, on July 18, 2023,
Catalyst acquired an exclusive license for North
America for vamorolone, a promising best-in-class dissociative
anti-inflammatory steroid treatment for patients suffering from
Duchenne muscular dystrophy. Vamorolone has received FDA Orphan
Drug and Fast Track designations and has been granted a PDUFA
action date of October 26, 2023.
For more information about Catalyst
Pharmaceuticals, Inc., visit the Company’s website
at: www.catalystpharma.com. For the Full Prescribing and
Safety Information for FIRDAPSE®, please
visit www.firdapse.com. For the Full Prescribing Information
for FYCOMPA®, please visit www.fycompa.com.
Forward-Looking StatementsThis
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 FYCOMPAFYCOMPA® (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
- Serious or life-threatening
psychiatric and behavioral adverse reactions including aggression,
hostility, irritability, anger, and homicidal ideation and threats
have been reported in patients taking FYCOMPA
- These reactions occurred in
patients with and without prior psychiatric history, prior
aggressive behavior, or concomitant use of medications associated
with hostility and aggression
- Advise patients and caregivers to
contact a healthcare provider immediately if any of these reactions
or changes in mood, behavior, or personality that are not typical
for the patient are observed while taking FYCOMPA or after
discontinuing FYCOMPA
- Closely monitor patients
particularly during the titration period and at higher doses
- FYCOMPA should be reduced if these
symptoms occur and should be discontinued immediately if symptoms
are severe or are worsening
|
SERIOUS PSYCHIATRIC AND BEHAVIORAL
REACTIONSIn 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
IDEATIONAntiepileptic 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
DISTURBANCEFYCOMPA 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 FATIGUEFYCOMPA
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.
FALLSFalls 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 AEDsA 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
REACTIONSThe 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 INTERACTIONSFYCOMPA 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
LACTATIONPhysicians 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 IMPAIRMENTUse
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
DEPENDENCEFYCOMPA 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 the
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
Catalyst Pharmaceuticals (NASDAQ:CPRX)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
Catalyst Pharmaceuticals (NASDAQ:CPRX)
Gráfico Histórico do Ativo
De Mai 2023 até Mai 2024