- This new treatment provides adults living with schizophrenia
a long-acting formulation that offers flexible 1- and 2-month
dosing intervals1
- In a Phase 3 clinical trial, UZEDY demonstrated up to 80%
reduction in risk of schizophrenia relapse versus placebo1
- UZEDY is a subcutaneous injection from a pre-filled syringe
with a 21-gauge needle
Regulatory News:
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical
Industries Ltd. (NYSE and TASE: TEVA), and MedinCell (Euronext:
MEDCL) announced today that the U.S. Food and Drug Administration
(FDA) has approved UZEDY (risperidone) extended-release injectable
suspension for the treatment of schizophrenia in adults. UZEDY is
the first subcutaneous, long-acting formulation of risperidone that
utilizes SteadyTeq™, a copolymer technology proprietary to
MedinCell that controls the steady release of risperidone.
Therapeutic blood concentrations are reached within 6-24 hours of a
single dose.1
“UZEDY embodies Teva’s commitment to bringing innovative
advances to patients and to providing people living with
schizophrenia an important new treatment option that was designed
to address certain treatment challenges and may decrease the risk
of relapse,” said Richard Francis, President and CEO of Teva. “The
approval of UZEDY is a culmination of a multidisciplinary effort
across Teva and MedinCell to bring this important treatment to
market. This milestone is a testament to advancing our robust
biopharmaceutical pipeline of innovative medicines that aim to
support more people living with mental health disorders and
neurological diseases in the coming years.”
Approximately 80% of patients with schizophrenia experience
multiple relapses over the first five years of treatment,2 most
commonly due to suboptimal adherence to treatment with oral
antipsychotics. Each relapse carries a biological risk of loss of
function, treatment refractoriness, and changes in brain
morphology.3,4
Schizophrenia is a chronic, progressive and severely
debilitating mental health disorder that affects how one thinks,
feels and acts.5 This approval is based on data from two Phase 3
trials evaluating UZEDY in patients with schizophrenia:
TV46000-CNS-30072 (the RISE Study – The Risperidone Subcutaneous
Extended-Release Study) and TV46000-CNS-30078 (the SHINE Study – A
Study to Test TV-46000 for Maintenance Treatment of
Schizophrenia).
"The approval of the first product formulated with our
technology is a pivotal moment for MedinCell and for the many
patients who will benefit,” said Christophe Douat, CEO of
MedinCell. “We are committed to supporting patients through
innovative therapy options. It continues to be a wonderful journey
with Teva, an ideal partner to harness the full potential of UZEDY.
Our technology reaching commercial stage marks the start of an
exciting new era for MedinCell and we are extremely proud to share
this very special moment with all our employees and
shareholders."
The use of novel SteadyTeq technology in UZEDY controls the
release of risperidone over time. The initiation of treatment
requires no loading dose or oral supplementation. Therapeutic blood
concentrations are reached within 6-24 hours of a single dose.1
“Treatments for schizophrenia are largely prescribed as daily
oral medications, which can present challenges with adherence due
to missed doses. Lack of adherence to treatment with oral
antipsychotics is the most common cause of relapse in
schizophrenia,6 so there’s a role for therapies that are dosed in
one- or two-month dosing intervals to help prevent relapse,” said
Christoph Correll, MD, professor of psychiatry at the Zucker School
of Medicine, Hempstead, NY. “As a clinician, I am excited to now
have a new treatment option that reduces the risk of relapse1 for
this complex disease and helps address some of the barriers around
receiving schizophrenia treatment.”
The Wholesale Acquisition Cost (WAC or “list price”) for UZEDY
ranges from $1,232 to $3,080 per month depending on dosage
strength. Actual costs for individual patients are anticipated to
be lower than WAC because WAC does not account for additional
rebates and discounts that may apply. Teva is committed to helping
patients who have been prescribed UZEDY access their medication and
provide patient support specialists to help with access and
reimbursement, prescription pull-through and patient assistance.
Savings on out-of-pocket costs may vary depending on the patient’s
insurance provider and eligibility for participation in the co-pay
assistance program.
UZEDY will be available in the U.S. in the coming weeks.
UZEDY Clinical Trial Results The RISE study7 was a
multicenter, randomized, double-blind, placebo-controlled study to
evaluate the efficacy of risperidone extended-release injectable
suspension for subcutaneous use as a treatment in patients (ages
13-65 years) with schizophrenia. 544 patients were randomized to
receive a subcutaneous injection of TV-46000 once monthly (q1M),
once every two months (q2M), or placebo in a 1:1:1 ratio. The
primary endpoint was time to impending relapse.
The second of Teva’s Phase 3 studies – SHINE8 – was designed to
evaluate the use of TV-46000 subcutaneously administered q1M or q2M
for up to 56 weeks in 336 patients (ages 13-65 years) with
schizophrenia. The primary endpoint was the frequency of all
adverse events, including serious adverse events. This study was
completed in December 2021; results align with the findings of the
RISE study.9
In a companion survey of study participants, 89% of patients and
92% of healthcare providers (HCPs) rated administration of UZEDY as
easy when asked how easy or difficult it was to receive or
administer the medication in its current form.10 Further, 70% of
patients agreed UZEDY provided a better injection experience than
their previous long-acting injectables (LAIs); 30% of patients
agreed they had a better injection experience with their prior LAI
medication.10 Moreover, given the choice between continuing to take
the clinical trial medication or returning to their previous
medication, 90% of patients opted to use UZEDY.10
Companion survey data were collected from 63 patients, 24
physicians, and 25 nurses in a prospective, cross-sectional
companion survey assessing the perceptions regarding ease of use
and satisfaction with UZEDY. The survey was conducted after a
minimum of two experiences prescribing, administering, or receiving
UZEDY.
About Schizophrenia Schizophrenia is a chronic,
progressive and severely debilitating mental disorder that affects
how one thinks, feels and acts. Patients experience an array of
symptoms, which may include delusions, hallucinations, disorganized
speech or behavior and impaired cognitive ability. Approximately 1%
of the world’s population will develop schizophrenia in their
lifetime, and 3.5 million people in the U.S. are currently
diagnosed with the condition. Although schizophrenia can occur at
any age, the average age of onset tends to be in the late teens to
the early 20s for men, and the late 20s to early 30s for women. The
long-term course of schizophrenia is marked by episodes of partial
or full remission broken by relapses that often occur in the
context of psychiatric emergency and require hospitalization.
Approximately 80% of patients experience multiple relapses over the
first five years of treatment, and each relapse carries a
biological risk of loss of function, treatment refractoriness, and
changes in brain morphology. Patients are often unaware of their
illness and its consequences, contributing to treatment
nonadherence, high discontinuation rates, and ultimately,
significant direct and indirect healthcare costs from subsequent
relapses and hospitalizations.
About UZEDY UZEDY (risperidone) extended-release
injectable suspension, for subcutaneous use rather than
intramuscular use, is indicated for the treatment of schizophrenia
in adults. In clinical trials, UZEDY reduced the risk of relapse by
up to 80%. UZEDY administers risperidone through copolymer
technology under license from MedinCell that allows for absorption
and sustained release in the first subcutaneous injection. UZEDY is
the only long-acting, subcutaneous formulation of risperidone
available in both one- and two-month dosing intervals.1 For full
prescribing information, visit
https://www.uzedy.com/globalassets/uzedy/prescribing-information.pdf.
INDICATION AND USAGE
UZEDY (risperidone) extended-release injectable suspension for
subcutaneous use is indicated for the treatment of schizophrenia in
adults.
IMPORTANT SAFETY INFORMATION
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. UZEDY is not
approved for use in patients with dementia-related psychosis and
has not been studied in this patient population.
CONTRAINDICATIONS: UZEDY is contraindicated in patients
with a known hypersensitivity to risperidone, its metabolite,
paliperidone, or to any of its components. Hypersensitivity
reactions, including anaphylactic reactions and angioedema, have
been reported in patients treated with risperidone or
paliperidone.
WARNINGS AND PRECAUTIONS
Cerebrovascular Adverse Reactions: In trials of elderly
patients with dementia-related psychosis, there was a significantly
higher incidence of cerebrovascular adverse events (e.g., stroke,
transient ischemic attack), including fatalities, in patients
treated with oral risperidone compared to placebo. UZEDY is not
approved for use in patients with dementia-related psychosis.
Neuroleptic Malignant Syndrome (NMS): NMS, a potentially
fatal symptom complex, has been reported in association with
antipsychotic drugs. Clinical manifestations of NMS are
hyperpyrexia, muscle rigidity, altered mental status including
delirium, and autonomic instability (irregular pulse or blood
pressure, tachycardia, diaphoresis, and cardiac dysrhythmia).
Additional signs may include elevated creatine phosphokinase,
myoglobinuria (rhabdomyolysis), and acute renal failure. If NMS is
suspected, immediately discontinue UZEDY and provide symptomatic
treatment and monitoring.
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 are believed 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. TD may remit, partially or completely,
if antipsychotic treatment is discontinued. Antipsychotic
treatment, itself, however, may suppress (or partially suppress)
the signs and symptoms of the syndrome, possibly masking 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
UZEDY, drug discontinuation should be considered. However, some
patients may require treatment with UZEDY despite the presence of
the syndrome. In patients who do require chronic treatment, use the
lowest dose and the shortest duration of treatment producing a
satisfactory clinical response. Periodically reassess the need for
continued treatment.
Metabolic Changes: Atypical antipsychotic drugs have been
associated with metabolic changes that may increase
cardiovascular/cerebrovascular risk. These metabolic changes
include hyperglycemia, dyslipidemia, and body weight gain. While
all of the drugs in the class have been shown to produce some
metabolic changes, each drug has its own specific risk profile.
Hyperglycemia and diabetes mellitus
(DM), in some cases extreme and associated with ketoacidosis or
hyperosmolar coma or death, have been reported in patients treated
with atypical antipsychotics, including risperidone. Patients with
an established diagnosis of DM who are started on atypical
antipsychotics, including UZEDY, should be monitored regularly for
worsening of glucose control. Patients with risk factors for DM
(e.g., obesity, family history of diabetes) who are starting
treatment with atypical antipsychotics, including UZEDY, should
undergo fasting blood glucose (FBG) testing at the beginning of
treatment and periodically during treatment. Any patient treated
with atypical antipsychotics, including UZEDY, should be monitored
for symptoms of hyperglycemia including polydipsia, polyuria,
polyphagia, and weakness. Patients who develop symptoms of
hyperglycemia during treatment with atypical antipsychotics,
including UZEDY, should undergo FBG testing. In some cases,
hyperglycemia has resolved when the atypical antipsychotic,
including risperidone, was discontinued; however, some patients
required continuation of antidiabetic treatment despite
discontinuation of risperidone.
Dyslipidemia has been observed in
patients treated with atypical antipsychotics.
Weight gain has been observed with
atypical antipsychotic use. Monitoring weight is recommended.
Hyperprolactinemia: As with other drugs that antagonize
dopamine D2 receptors, risperidone elevates prolactin levels and
the elevation persists during chronic administration. Risperidone
is associated with higher levels of prolactin elevation than other
antipsychotic agents.
Orthostatic Hypotension and Syncope: UZEDY may induce
orthostatic hypotension associated with dizziness, tachycardia, and
in some patients, syncope. UZEDY should be used with particular
caution in patients with known cardiovascular disease,
cerebrovascular disease, and conditions which would predispose
patients to hypotension and in the elderly and patients with renal
or hepatic impairment. Monitoring of orthostatic vital signs should
be considered in all such patients, and a dose reduction should be
considered if hypotension occurs. Clinically significant
hypotension has been observed with concomitant use of oral
risperidone and antihypertensive medication.
Falls: Antipsychotics, including UZEDY, may cause
somnolence, postural hypotension, motor and sensory instability,
which may lead to falls and, consequently, fractures or other
fall-related injuries. Somnolence, postural hypotension, motor and
sensory instability have been reported with the use of risperidone.
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 have been
reported with antipsychotic agents, including risperidone. In
patients with a pre-existing history of a clinically significant
low white blood cell count (WBC) or absolute neutrophil count (ANC)
or a history of drug-induced leukopenia or neutropenia, perform a
complete blood count (CBC) frequently during the first few months
of therapy. In such patients, consider discontinuation of UZEDY 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 UZEDY in patients with ANC < 1000/mm3) and
follow their WBC until recovery.
Potential for Cognitive and Motor Impairment: UZEDY, like
other antipsychotics, may cause somnolence and has the potential to
impair judgement, thinking, and motor skills. Somnolence was a
commonly reported adverse reaction associated with oral risperidone
treatment. Caution patients about operating hazardous machinery,
including motor vehicles, until they are reasonably certain that
treatment with UZEDY does not affect them adversely.
Seizures During premarketing studies of oral risperidone
in adult patients with schizophrenia, seizures occurred in 0.3% of
patients (9 out of 2,607 patients), two in association with
hyponatremia. Use UZEDY cautiously in patients with a history of
seizures or other conditions that potentially lower the seizure
threshold.
Dysphagia: Esophageal dysmotility and aspiration have
been associated with antipsychotic drug use. Antipsychotic drugs,
including UZEDY, should be used cautiously in patients at risk for
aspiration.
Priapism has been reported during postmarketing
surveillance for other risperidone products. A case of priapism was
reported in premarket studies of UZEDY. Severe priapism may require
surgical intervention.
Body temperature regulation. Disruption of the body’s
ability to reduce core body temperature has been attributed to
antipsychotic agents. Both hyperthermia and hypothermia have been
reported in association with oral risperidone use. Strenuous
exercise, exposure to extreme heat, dehydration, and
anticholinergic medications may contribute to an elevation in core
body temperature; use UZEDY with caution in patients who experience
these conditions.
ADVERSE REACTIONS
The most common adverse reactions with risperidone (≥5% and
greater than placebo) were parkinsonism, akathisia, dystonia,
tremor, sedation, dizziness, anxiety, blurred vision, nausea,
vomiting, upper abdominal pain, stomach discomfort, dyspepsia,
diarrhea, salivary hypersecretion, constipation, dry mouth,
increased appetite, increased weight, fatigue, rash, nasal
congestion, upper respiratory tract infection, nasopharyngitis, and
pharyngolaryngeal pain.
The most common injection site reactions with UZEDY (≥5% and
greater than placebo) were pruritus and nodule.
DRUG INTERACTIONS
- Carbamazepine and other strong CYP3A4 inducers decrease plasma
concentrations of risperidone.
- Fluoxetine, paroxetine, and other strong CYP2D6 inhibitors
increase risperidone plasma concentration.
- Due to additive pharmacologic effects, the concomitant use of
centrally-acting drugs, including alcohol, may increase nervous
system disorders.
- UZEDY may enhance the hypotensive effects of other therapeutic
agents with this potential.
- UZEDY may antagonize the pharmacologic effects of dopamine
agonists.
- Concomitant use with methylphenidate, when there is change in
dosage of either medication, may increase the risk of
extrapyramidal symptoms (EPS)
USE IN SPECIFIC POPULATIONS
Pregnancy: May cause EPS 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 UZEDY, 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 risperidone through
breastmilk should be monitored for excess sedation, failure to
thrive, jitteriness, and EPS.
Fertility: UZEDY may cause a reversible reduction in
fertility in females.
Pediatric Use: Safety and effectiveness of UZEDY have not
been established in pediatric patients.
Renal or Hepatic Impairment: Carefully titrate on oral
risperidone up to at least 2 mg daily before initiating treatment
with UZEDY.
Patients with Parkinson’s disease or dementia with Lewy
bodies can experience increased sensitivity to UZEDY.
Manifestations and features are consistent with NMS.
Please see the full Prescribing Information for
UZEDY, including Boxed WARNING.
About Teva Teva Pharmaceutical Industries Ltd. (NYSE and
TASE: TEVA) has been developing and producing medicines to improve
people’s lives for more than a century. We are a global leader in
generic, biosimilar and innovative medicines with a portfolio
consisting of over 3,500 products in nearly every therapeutic area.
Around 200 million people around the world take a Teva medicine
every day, and are served by one of the largest and most complex
supply chains in the pharmaceutical industry. Along with our
established presence in generics, we have significant innovative
research and operations supporting our growing portfolio of
innovative medicines and biopharmaceutical products. Learn more at
www.tevapharm.com.
About MedinCell MedinCell is an innovative pharmaceutical
company with a portfolio of long-acting injectable products, from
development to market, in various therapeutic areas. MedinCell
proprietary technology BEPO® (licensed to Teva under the name
SteadyTeq) makes it possible to control the delivery of a drug at a
therapeutic dose for several days, weeks or months starting from
the subcutaneous or local injection of a simple deposit of a few
millimeters, fully bioresorbable. MedinCell collaborate with tier
one pharmaceuticals companies and foundations to improve Global
Health through new therapeutic options. Based in Montpellier,
MedinCell currently employs more than 140 people representing over
25 different nationalities. www.medincell.com
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, which are based on management’s current beliefs and
expectations and are subject to substantial risks and
uncertainties, both known and unknown, that could cause our future
results, performance or achievements to differ significantly from
that expressed or implied by such forward-looking statements. You
can identify these forward-looking statements by the use of words
such as “should,” “expect,” “anticipate,” “estimate,” “target,”
“may,” “project,” “guidance,” “intend,” “plan,” “believe” and other
words and terms of similar meaning and expression in connection
with any discussion of future operating or financial performance.
Important factors that could cause or contribute to such
differences include risks relating to:
- our ability to develop and commercialize UZEDY (risperidone)
extended-release injectable suspension for the treatment
schizophrenia;
- our ability to successfully compete in the marketplace,
including: that we are substantially dependent on our generic
products; concentration of our customer base and commercial
alliances among our customers; delays in launches of new generic
products; the increase in the number of competitors targeting
generic opportunities and seeking U.S. market exclusivity for
generic versions of significant products; our ability to develop
and commercialize biopharmaceutical products; competition for our
innovative medicines, including AUSTEDO®, AJOVY® and COPAXONE®; our
ability to achieve expected results from investments in our product
pipeline; our ability to develop and commercialize additional
pharmaceutical products; and the effectiveness of our patents and
other measures to protect our intellectual property rights;
- our substantial indebtedness, which may limit our ability to
incur additional indebtedness, engage in additional transactions or
make new investments, may result in a further downgrade of our
credit ratings; and our inability to raise debt or borrow funds in
amounts or on terms that are favorable to us;
- our business and operations in general, including: the impact
of global economic conditions and other macroeconomic developments
and the governmental and societal responses thereto; the widespread
outbreak of an illness or any other communicable disease, or any
other public health crisis; effectiveness of our optimization
efforts; our ability to attract, hire, integrate and retain highly
skilled personnel; manufacturing or quality control problems;
interruptions in our supply chain; disruptions of information
technology systems; breaches of our data security; variations in
intellectual property laws; challenges associated with conducting
business globally, including political or economic instability,
major hostilities or terrorism; costs and delays resulting from the
extensive pharmaceutical regulation to which we are subject;
- the effects of reforms in healthcare regulation and reductions
in pharmaceutical pricing, reimbursement and coverage; significant
sales to a limited number of customers; our ability to successfully
bid for suitable acquisition targets or licensing opportunities, or
to consummate and integrate acquisitions; and our prospects and
opportunities for growth if we sell assets;
- compliance, regulatory and litigation matters, including:
failure to comply with complex legal and regulatory environments;
increased legal and regulatory action in connection with public
concern over the abuse of opioid medications and any delay in our
ability to obtain sufficient participation of plaintiffs for the
nationwide settlement of our opioid-related litigation in the
United States; scrutiny from competition and pricing authorities
around the world, including our ability to successfully defend
against the U.S. Department of Justice criminal charges of Sherman
Act violations; potential liability for intellectual property right
infringement; product liability claims; failure to comply with
complex Medicare and Medicaid reporting and payment obligations;
compliance with anti-corruption, sanctions and trade control laws;
environmental risks; and the impact of ESG issues;
- other financial and economic risks, including: our exposure to
currency fluctuations and restrictions as well as credit risks;
potential impairments of our long-lived assets; the impact of
geopolitical conflicts including the ongoing conflict between
Russia and Ukraine; potential significant increases in tax
liabilities; and the effect on our overall effective tax rate of
the termination or expiration of governmental programs or tax
benefits, or of a change in our business; and other factors
discussed in this press release and in our Annual Report on Form
10-K for the year ended December 31, 2022, including in the
sections captioned "Risk Factors” and “Forward Looking Statements.”
Forward-looking statements speak only as of the date on which they
are made, and we assume no obligation to update or revise any
forward-looking statements or other information contained herein,
whether as a result of new information, future events or otherwise.
You are cautioned not to put undue reliance on these
forward-looking statements.
___________________________ 1 UZEDY™ (risperidone)
extended-release injectable suspension, for subcutaneous injection
Current Prescribing Information. Parsippany, NJ. Teva Neuroscience,
Inc. 2 Emsley, R., & Kilian, S. (2018). Efficacy and safety
profile of paliperidone palmitate injections in the management of
patients with schizophrenia: an evidence-based review.
Neuropsychiatric disease and treatment, 14, 205–223. 3 Emsley, R.,
Chiliza, B., Asmal, L. et al. (2013) The nature of relapse in
schizophrenia. BMC Psychiatry 13, 50. 4 Andreasen, N. C., et al.
(2013). Relapse duration, treatment intensity, and brain tissue
loss in schizophrenia: a prospective longitudinal MRI study. The
American journal of psychiatry, 170(6), 609–615. 5 Patel, K. R.,
Cherian, J., Gohil, K., & Atkinson, D. (2014). Schizophrenia:
overview and treatment options. P & T: a peer-reviewed journal
for formulary management, 39(9), 638–645.. 6 Kane JM, Correll CU.
Optimizing treatment choices to improve adherence and outcomes in
schizophrenia. J Clin Psychiatry. 2019;80(5):IN18031AH1C.
doi:10.4088/JCP.IN18031AH1C. 7 “A Multicenter, Randomized,
Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy,
Safety, and Tolerability of Risperidone Extended-Release Injectable
Suspension (TV-46000) for Subcutaneous Use as Maintenance Treatment
in Adult and Adolescent Patients With Schizophrenia.”
ClinicalTrials.gov, U.S. National Institutes of Health, 2018
(NCT03503318). 8 “A Study to Evaluate the Safety, Tolerability, and
Effect of Risperidone Extended-Release Injectable Suspension
(TV-46000) for Subcutaneous Use as Maintenance Treatment in Adult
and Adolescent Patients With Schizophrenia.” ClinicalTrials.gov,
U.S. National Institutes of Health, 2019 (NCT03893825). 9 Data on
File. Parsippany, NJ: Teva Neuroscience, Inc. 10 Robinson, D.,
Suett, M., Wilhelm, A. et al. (2023). Patient and Healthcare
Professional Preferences for Characteristics of Long-Acting
Injectable Antipsychotic Agents for the Treatment of
Schizophrenia.doi.org/10.1007/s12325-023-02455-8.
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