PRINCETON, N.J., July 28,
2024 /PRNewswire/ -- Luye Pharma Group (Luye Pharma),
an international pharmaceutical company dedicated to the R&D,
manufacturing and sales of innovative medications, today announced
that the U.S. Food and Drug Administration (FDA) has approved the
company's ERZOFRI® (paliperidone palmitate)
extended-release injectable suspension, for treating schizophrenia
in adults and for treating schizoaffective disorder in adults as
monotherapy and as an adjunct to mood stabilizers or
antidepressants.
Both schizophrenia and schizoaffective disorder are severe,
chronic psychiatric disorders characterized by recurring
relapses[1]. Antipsychotic medications play an important
role in treating and controlling symptoms of schizophrenia and
schizoaffective disorder, but patient adherence to antipsychotics
is generally poor. Using long-acting injectable (LAI)
antipsychotics is effective in improving patient adherence, as they
can reduce the dosing frequency and can also reduce the risk of
patients not adhering to their dosing regimen without the knowledge
of their healthcare providers[2].
ERZOFRI, administered once a month, is the first patented
paliperidone palmitate long-acting injection developed in
China to get approved in the U.S.
The product was granted a U.S. patent (Patent No.11,666,573) in
2023, which will expire in 2039. ERZOFRI is approved as a new drug
under the 505(b) (2) pathway in the U.S.
According to publicly available information, the sales of
paliperidone palmitate LAIs were $2.897
billion across the U.S. in 2023[3]. ERZOFRI will provide patients
with a new treatment option after its launch.
ABOUT ERZOFRI®
What is ERZOFRI (paliperidone palmitate) extended-release
injectable suspension?
ERZOFRI is an atypical antipsychotic indicated for:
- The treatment of schizophrenia in adults.
- The treatment of schizoaffective disorder in adults as
monotherapy and as an adjunct to mood stabilizers or
antidepressants.
IMPORTANT SAFETY INFORMATION FOR ERZOFRI
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS
Elderly patients with dementia-related psychosis treated with
antipsychotic drugs are at an increased risk of death. ERZOFRI is
not approved for use in patients with dementia-related
psychosis.
CONTRAINDICATIONS: ERZOFRI is contraindicated in patients with a
known hypersensitivity to either paliperidone or risperidone, or to
any of the excipients in the ERZOFRI formulation. Hypersensitivity
reactions, including anaphylactic reactions and angioedema, have
been reported in patients treated with risperidone and in patients
treated with paliperidone.
WARNINGS AND PRECAUTIONS
Cerebrovascular Adverse Reactions: In clinical trials in
elderly patients with dementia-related psychosis, increased risk of
cerebrovascular adverse reactions (cerebrovascular accidents and
transient ischemic attacks), including fatalities, have been
reported in patients taking atypical antipsychotic medications
compared to placebo. ERZOFRI is not approved for the treatment of
patients with dementia-related psychosis.
Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal
symptom complex, has been reported in association with
antipsychotic drugs. Manage with immediate discontinuation and
close monitoring.
QT Prolongation: Paliperidone causes a modest increase in the
corrected QT (QTc) interval. The use of paliperidone should be
avoided in combination with other drugs that are known to prolong
QTc. Paliperidone should also be avoided in patients with
congenital long QT syndrome and in patients with a history of
cardiac arrhythmias.
Tardive Dyskinesia (TD): TD, a syndrome consisting of
potentially irreversible, involuntary, dyskinetic movements, may
develop in patients treated with antipsychotic drugs. Although the
prevalence of the syndrome appears to be highest among the elderly,
especially elderly women, it is impossible to predict which
patients will develop the syndrome. Whether antipsychotic drug
products differ in their potential to cause TD is unknown.
The risk of developing TD and the likelihood that it will become
irreversible appear to increase with the duration of treatment and
the cumulative dose. The syndrome can develop after relatively
brief treatment periods, even at low doses. It may also occur after
discontinuation of treatment. TD may remit, partially or
completely, if antipsychotic treatment is discontinued.
Antipsychotic treatment itself may suppress (or partially suppress)
the signs and symptoms of the syndrome and may thus mask the
underlying process. The effect that symptomatic suppression has
upon the long-term course of the syndrome is unknown.
If signs and symptoms of TD appear in a patient treated with
ERZOFRI, drug discontinuation should be considered. However, some
patients may require treatment with ERZOFRI despite the presence of
the syndrome.
Metabolic Changes: Atypical antipsychotic drugs have been
associated with metabolic changes, including hyperglycemia,
dyslipidemia, and body weight gain.
Hyperglycemia and Diabetes
Mellitus: Hyperglycemia and diabetes mellitus, in some cases
extreme and associated with ketoacidosis or hyperosmolar coma or
death, have been reported in patients treated with all atypical
antipsychotics. Patients with an established diagnosis of diabetes
mellitus who are started on atypical antipsychotics should be
monitored regularly for worsening glucose control. Patients with
risk factors for diabetes mellitus who are starting treatment with
atypical antipsychotics, including ERZOFRI, should undergo fasting
blood glucose testing at the beginning of treatment and
periodically during treatment. Any patient treated with atypical
antipsychotics should be monitored for symptoms of hyperglycemia
including polydipsia, polyuria, polyphagia, and weakness. Patients
who develop symptoms of hyperglycemia during treatment with
atypical antipsychotics should undergo fasting blood glucose
testing. In some cases, hyperglycemia resolved when the atypical
antipsychotic was discontinued; however, some patients required
continuation of anti-diabetic treatment despite discontinuation of
the suspect drug.
Dyslipidemia: Undesirable alterations in
lipids have been observed in patients treated with atypical
antipsychotics.
Weight Gain: Weight gain has been observed
with atypical antipsychotic use. Monitoring weight is
recommended.
Orthostatic Hypotension and Syncope: Paliperidone can
induce orthostatic hypotension and syncope in some patients. Use
ERZOFRI with caution in patients with known cardiovascular disease
(e.g., heart failure, history of myocardial infarction or ischemia,
conduction abnormalities), cerebrovascular disease, or conditions
that predispose the patient to hypotension. Monitoring of
orthostatic vital signs should be considered in patients who are
vulnerable to hypotension.
Falls: Somnolence, postural hypotension, motor and sensory
instability have been reported with the use of antipsychotics,
including paliperidone palmitate, which may lead to falls and,
consequently, fractures or other fall-related injuries. For
patients, particularly the elderly, with diseases, conditions, or
medications that could exacerbate these effects, assess the risk of
falls when initiating antipsychotic treatment and recurrently for
patients on long-term antipsychotic therapy.
Leukopenia, Neutropenia, and Agranulocytosis: Events of
leukopenia, neutropenia, and agranulocytosis have been reported
temporally related to antipsychotic agents. Patients with a history
of a clinically significant low white blood cell count
(WBC)/absolute neutrophil count (ANC) or past drug-induced
leukopenia/neutropenia should have their complete blood count (CBC)
monitored frequently during the first few months of therapy.
Discontinuation of ERZOFRI should be considered at the first sign
of a clinically significant decline in WBC in the absence of other
causative factors.
Monitor patients with clinically significant neutropenia for
fever or other symptoms or signs of infection and treat promptly if
such symptoms or signs occur. Discontinue ERZOFRI in patients with
absolute neutrophil count <1000/mm3 and follow their
WBC until recovery.
Hyperprolactinemia: Like other drugs that antagonize
dopamine D2 receptors, paliperidone elevates prolactin levels and
the elevation persists during chronic administration. Paliperidone
has a prolactin-elevating effect similar to that seen with
risperidone, a drug that is associated with higher levels of
prolactin than other antipsychotic drugs. Long-standing
hyperprolactinemia, when associated with hypogonadism, can lead to
decreased bone density in males and females.
Potential for Cognitive and Motor
Impairment: Antipsychotics, including ERZOFRI, have the
potential to impair judgement, thinking, and motor skills. Patients
should be cautioned about performing activities requiring mental
alertness, such as operating hazardous machinery or operating a
motor vehicle, until they are reasonably certain that paliperidone
therapy does not adversely affect them.
Seizures: ERZOFRI should be used cautiously in patients
with a history of seizures or with conditions that potentially
lower the seizure threshold.
Dysphagia: Esophageal dysmotility and aspiration have been
associated with antipsychotic drug use. Antipsychotic drugs,
including ERZOFRI, should be used cautiously in patients at risk
for aspiration.
Priapism: Priapism has been reported with oral paliperidone
during postmarketing surveillance. Severe priapism may require
surgical intervention.
Disruption of Body Temperature Regulation: Disruption of
the body's ability to reduce core body temperature has been
attributed to antipsychotic agents. Appropriate care is advised
when prescribing ERZOFRI to patients who will be experiencing
conditions which may contribute to an elevation in core body
temperature, such as exercising strenuously, exposure to extreme
heat, receiving anticholinergic medications, or dehydration.
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥ 5% and occurring
at least twice as often as placebo) were injection site reactions,
somnolence/sedation, dizziness, akathisia, and extrapyramidal
disorder.
DRUG INTERACTIONS
An additive effect may occur when co-administered ERZOFRI with
drugs that may cause orthostatic hypotension.
Avoid using a strong inducer of CYP3A4 and/or P-glycoprotein
(P-gp) during a dosing interval for ERZOFRI. If concomitant use is
necessary, consider using paliperidone extended-release
tablets.
USE IN SPECIFIC POPULATIONS
Pregnancy: May cause extrapyramidal and/or withdrawal
symptoms in neonates with third trimester exposure. There is a
pregnancy exposure registry that monitors pregnancy outcomes in
women exposed to atypical antipsychotics, including ERZOFRI, during
pregnancy. Healthcare providers are encouraged to register patients
by contacting the National Pregnancy Registry for Atypical
Antipsychotics at 1-866-961-2388 or online at
http://womensmentalhealth.org/clinicaland-research-programs/pregnancyregistry/.
Lactation: Infants exposed to ERZOFRI through breastmilk
should be monitored for excess sedation, failure to thrive,
jitteriness, and extrapyramidal symptoms (tremors and abnormal
muscle movements).
Fertility: Based on the pharmacologic action of
paliperidone (D2 receptor antagonism), treatment with ERZOFRI may
result in an increase in serum prolactin levels, which may lead to
a reversible reduction in fertility in females of reproductive
potential.
Pediatric Use: Safety and effectiveness of ERZOFRI in pediatric
patients have not been established.
Please see full Prescribing Information
at https://www.luye.cn/lvye_en/erzofri.pdf, including BOXED
WARNING, for ERZOFRI.
About the Clinical Trial
The U.S. FDA approval of ERZOFRI is based on the results of an
open-label, randomized, multiple-dose, parallel-group study that
enrolled 281 patients (ages 18-65) with schizophrenia or
schizoaffective disorder (NCT04922593), designed to evaluate the PK
profile of ERZOFRI and its relative bioavailability compared with
the listed drug INVEGA SUSTENNA®. ERZOFRI was
demonstrated to be bioequivalent to the listed drug at steady state
after multiple injections. Compared with the listed drug, the
initial dosing was optimized for ERZOFRI by omitting the injection
on Day 8 after the first injection, resulting in a comparable total
drug exposure.
The safety profile of ERZOFRI was consistent with the known
safety profile of the listed drug.
About Luye Pharma Group
Luye Pharma Group is an international pharmaceutical company
dedicated to the R&D, manufacturing and sale of innovative
medications. The company has established R&D centers in
China, the U.S. and Europe, with a robust pipeline of over 30 drug
candidates in China and more than
10 drug candidates in other international markets. Luye Pharma
maintains high-level international standards in novel drug delivery
technologies including microspheres, liposomes, and transdermal
drug delivery systems. The company has achieved multiple
innovations in new chemical entities and antibodies, and is also
actively making strategic developments in the fields of cell
therapies and gene therapies.
Luye Pharma is developing a global supply chain of 8
manufacturing sites built up around the world, with GMP quality
management and control systems established in line with
international standards. With more than 30 products covering the
central nervous system, oncology, cardiovascular, metabolism and
other therapeutic areas, business is conducted in over 80 countries
and regions around the world, including the largest pharmaceutical
markets -- China, the U.S.,
Europe and Japan, as well as in fast growing emerging
markets.
[1]. Anne Rivelli,
Veronica Fitzpatrick, Michael Nelson, et al. Real-world predictors
of relapse in patients with schizophrenia and schizoaffective
disorder in a large health system. Schizophrenia (Heidelb)
(2024). DOI: 10.1038/s41537-024-00448-2.
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[2]. Carmela
Benson, Charmi Patel, Inyoung Lee, et al. Treatment
patterns and hospitalizations following rejection, reversal, or
payment of the initial once-monthly paliperidone palmitate
long-acting injectable antipsychotic claim among patients with
schizophrenia or schizoaffective disorder. J Manag Care Spec
Pharm. 2024 Jun 3:1-13. doi:
10.18553/jmcp.2024.23252.
|
[3]. Johnson &
Johnson. 2023 Annual Report. Available at:
https://s203.q4cdn.com/636242992/files/doc_downloads/Annual_meeting/2024/Johnson-Johnson-2023-Annual-Report.pdf.
Accessed on July 15, 2024.
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SOURCE Luye Pharma Group