- UZEDY significantly reduced the risk of relapse by up to 80%
and prolonged the time to impending relapse by up to 5.0 times
while having a similar safety profile to other formulations of
risperidone1,2
- The U.S. Food and Drug Administration (FDA) approved UZEDY
on April 28, 2023 for the treatment of schizophrenia in adults as a
subcutaneous injection every one or two months using a pre-filled
syringe
- Symposia on IMPACT-TD scale for tardive dyskinesia (TD)
progression measurement and clinical education tool for
schizophrenia, S.C.O.P.E., are also to be presented
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical
Industries Ltd. (NYSE and TASE: TEVA), today announced that four
studies across its neuroscience portfolio will be presented during
the American Psychiatric Association’s (APA) 2023 Annual Meeting
taking place on May 20-24, 2023. Abstracts include data for UZEDY
(risperidone) extended-release injectable suspension for
subcutaneous use, which was recently approved by the FDA for the
treatment of schizophrenia in adults. Additional abstracts being
presented include data on characteristics that impact TD diagnosis
and machine-learning to identify unique patient segments for TD. TD
is a chronic movement disorder that affects one in four people who
take certain mental health treatments.3-5
Of the data being presented, Teva will share findings from two
trials that supported the FDA approval of UZEDY, the RISE Study
(The Risperidone Subcutaneous Extended-Release Study) and the SHINE
Study (A Study to Test TV-46000 for Maintenance Treatment of
Schizophrenia).6,7 The RISE data demonstrated that UZEDY
significantly prolonged time to impending relapse by 5.0
(once-monthly dosing) and 2.7 (once-every-two-months dosing) times
versus placebo in patients with schizophrenia.2 Additionally, the
SHINE data confirmed the safety profile of UZEDY is consistent with
other formulations of risperidone.2
“We’re pleased to present the foundational data that supported
the FDA’s approval of UZEDY, an important new treatment option for
adults with schizophrenia,” said Eric Hughes, MD, PhD, Executive
Vice President of Global R&D and Chief Medical Officer at Teva.
“We know schizophrenia patients experience a number of challenges
when it comes to this condition, and are optimistic that UZEDY can
help address the unmet needs of patients, their caregivers, and
physicians.”
Findings from the RISE and SHINE studies demonstrate that UZEDY
is efficacious with the known safety profile of risperidone. The
innovative long-acting formulation of UZEDY allows for both
absorption and sustained release after subcutaneous injection and
is available with a range of dosing options. UZEDY utilizes
SteadyTeq™, a copolymer technology proprietary to MedinCell, that
controls the rate and duration of risperidone release. With this
delivery system, therapeutic blood concentrations are reached
within 6-24 hours of a single dose.1
In addition to the data, Teva will also be holding a symposium
on the newly developed IMPACT-TD scale, featuring Richard Jackson,
MD, Assistant Clinical Adjunct Professor, University of Michigan
School of Medicine Department of Psychiatry, that may help better
measure disease progression of those living with TD by taking a
holistic approach to tracking social, vocational, psychological and
psychiatric challenges the condition poses over time. A symposium
on S.C.O.P.E. featuring John Kane, MD, Professor and Chairman,
Department of Psychiatry, The Donald and Barbara Zucker School of
Medicine at Hofstra/Northwell, will also be presented – an
educational tool for schizophrenia that helps teach physicians
about common myths and misconceptions, manage frequent clinical
dilemmas and identify the latest therapeutic options.
This year’s annual APA meeting is being offered both in person
and virtually. Abstracts can be accessed here.
The full set of data sponsored by Teva includes:
Symposium: Saturday, May 20, 2:00 PM - 3:00 PM PT
- Guiding the S.C.O.P.E. of schizophrenia care forward through
interactive digital education for clinicians
Symposium: Monday, May 22, 12:15 PM - 12:45 PM PT
- IMPACT-TD scale: A novel tool to assess the true story of the
impact of TD in our patients
Poster Session 12: Tuesday, May 23, 1:30 PM - 3:00 PM
PT
- (De novo) Use of Machine-Learning to Identify Unique Patient
Segments Within the Tardive Dyskinesia Population (5040)
- (De novo) Assessment of Underdiagnosis of Tardive Dyskinesia
(TD) by Geographic Region, Social Determinants, and Other Patient
Characteristics (4939)
Poster Session 13: Tuesday, May 23, 3:45 PM - 5:15 PM
PT
- (De novo) TV-46000, a Long-Acting Subcutaneous Antipsychotic
(LASCA) in Schizophrenia: Phase 3 Study (RISE) and Long-Term Safety
and Tolerability Study (SHINE) (5523)
- (De novo) Myths, Misconceptions, and Clinical Dilemmas
Surrounding the Use of Long-acting Injectable Antipsychotic Agents
for Treatment of Schizophrenia (4779)
About Tardive Dyskinesia (TD) Tardive dyskinesia (TD) is
a highly debilitating, chronic movement disorder that affects one
in four people who take certain mental health treatments and is
characterized by uncontrollable, abnormal, and repetitive movements
of the face, torso, and/or other body parts, which may be
disruptive and negatively impact individuals.3-5
About Schizophrenia Schizophrenia is a chronic,
progressive and severely debilitating mental disorder that affects
how one thinks, feels and acts.8 Patients experience an array of
symptoms, which may include delusions, hallucinations, disorganized
speech or behavior and impaired cognitive ability.8-10
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.9,10 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.8 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.8 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.11-13 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.8-13
About UZEDY UZEDY (risperidone) extended-release
injectable suspension, for subcutaneous use, is indicated for the
treatment of schizophrenia in adults. In clinical trials, UZEDY
reduced the risk of relapse by up to 80%.1 UZEDY administers
risperidone through copolymer technology under license from
MedinCell that allows for absorption and sustained release after
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 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 and
biopharmaceutical products. Learn more at www.tevapharm.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 the development and commercial success of UZEDY
(risperidone) extended-release injectable suspension for the
treatment of schizophrenia; our ability to successfully compete in
the marketplace, including our ability to develop and commercialize
competition for our innovative medicines, 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; our business and operations in general, including,
the impact of global economic conditions and other macroeconomic
developments and the governmental and societal responses thereto,
and costs and delays resulting from the extensive pharmaceutical
regulation to which we are subject; compliance, regulatory and
litigation matters, including failure to comply with complex legal
and regulatory environments; other financial and economic risks;
and other factors discussed in our Quarterly Report on Form 10-Q
for the first quarter of 2023 and in our Annual Report on Form 10-K
for the year ended December 31, 2022, including in the section
captioned “Risk Factors.” 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
Kane J, Sharon N. TV-46000, a Long-Acting Subcutaneous
Antipsychotic (LASCA) in Schizophrenia: Phase 3 Study (RISE) and
Long-Term Safety and Tolerability Study (SHINE). American
Psychiatric Association’s 2023 Annual Meeting; 2023. May 20-24.
Hybrid congress. 3 Warikoo N, Schwartz T, Citrome L. Tardive
dyskinesia. In: Schwartz TL, Megna J, Topel ME, eds. Antipsychotic
Drugs. Hauppauge, NY: Nova Science Publishers. 2013:235-258. 4 Waln
O, Jankovic J. An Update on Tardive Dyskinesia: From Phenomenology
to Treatment. Tremor Other Hyperkinet Mov. 2013;3:1-11. 5 Tardive
dyskinesia. National Alliance on Mental Illness website.
https://www.nami.org/Learn-More/Treatment/Mental-Health-Medications/Tardive-Dyskinesia.
Accessed May 4, 2023. 6 “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). 7 “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). 8 Substance Abuse and Mental Health
Services Administration. Schizophrenia. April 24, 2023.
https://www.samhsa.gov/mental-health/schizophrenia. Accessed May
2023. 9 Velligan DI, Rao S. The epidemiology and global burden of
schizophrenia. J Clin Psychiatry. 2023;84(1):MS21078COM5.
https://doi.org/10.4088/JCP.MS21078COM5. 10 Wander C. (2020).
Schizophrenia: opportunities to improve outcomes and reduce
economic burden through managed care. The American journal of
managed care, 26(3 Suppl), S62–S68.
https://doi.org/10.37765/ajmc.2020.43013 11 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. 12 Emsley, R., Chiliza, B., Asmal, L.
et al. (2013) The nature of relapse in schizophrenia. BMC
Psychiatry 13, 50. 13 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.
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