- UZEDY is currently approved in the US as a subcutaneous
long-acting injectable (LAI) for use every one or two months for
the treatment of schizophrenia in adults1
- LAI treatment options may help address unmet needs of people
living with bipolar I disorder (BP-I)
- BP-I filing acceptance for UZEDY represents Teva’s
commitment to pursuing new advances in neuroscience
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 supplemental New Drug Application
(sNDA) for UZEDY extended-release injectable suspension for the
maintenance treatment of BP-I in adults has been accepted for
filing by the U.S. Food and Drug Administration (FDA).
The sNDA is based on leveraging the existing clinical data for
UZEDY coupled with the Agency’s previous findings of safety and
efficacy of past risperidone formulations approved for the
treatment of BP-I.
“Since the FDA approval of UZEDY almost two years ago, it has
proven to be an important treatment option for people living with
schizophrenia,” said Eric Hughes, MD, PhD, Executive Vice President
of Global R&D and Chief Medical Officer at Teva. “Today’s
filing demonstrates the potential of UZEDY’s clinical profile as a
long-acting treatment for bipolar-I, a complex mental health
disorder that significantly affects a person’s mood, behavior, and
overall state of mind. Debilitating manic and depressive symptoms
and signs can also occur.”
Teva will lead the regulatory process and be responsible for
potential commercialization of UZEDY for BP-I, with Medincell
eligible for royalties on net sales.
“Long-acting injectables are key drivers of innovation in the
CNS field today,” said Dr. Richard Malamut, Chief Medical Officer
at Medincell. “In bipolar I disorder, as in schizophrenia,
nonadherence remains a major barrier to effective care, one that
UZEDY has the potential to help. We are proud to partner with Teva
to deliver treatment options aimed at meeting unmet medical
needs.”
UZEDY was approved in the U.S. for the treatment of
schizophrenia in adults in 2023.2
The efficacy and long-term safety and tolerability of UZEDY for
the treatment of schizophrenia have been evaluated in two Phase 3
pivotal studies: TV46000-CNS-30072 (the RISE Study – The
Risperidone Subcutaneous Extended-Release Study)3 and
TV46000-CNS-30078 (the SHINE Study – Safety in Humans of TV-46000
sc INjection Evaluation)2.
The safety and efficacy of UZEDY for BP-I are not established
and UZEDY is not approved by any regulatory authority for this
indication.
About Bipolar I Disorder
Bipolar Disorder I (BP-I) is a manic-depressive condition that
leads to large swings in mood and actions that greatly impact
quality of life and ability to complete day-to-day tasks. It is
challenging to diagnose and is often accompanied by other
psychiatric comorbidities. BP-I is associated with poor long-term
outcomes and a substantial increase in mortality compared to the
general population from both suicide and cardiovascular disease. An
estimated 1% or 3,400,000+ of U.S. adults will develop BP-I in
their lifetime.4
About the RISE Study
RISE, Teva’s Phase 3 study, 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.3 544 patients were randomized to receive a
subcutaneous injection of UZEDY once monthly (q1M), once every two
months (q2M), or placebo in a 1:1:1 ratio. The primary endpoint was
time to impending relapse.3
About the SHINE Study
The second of Teva’s Phase 3 studies; designed to evaluate the
long-term safety, tolerability and effectof UZEDY subcutaneously
administered q1M or q2M for up to 56 weeks in 331 patients (ages
13-65 years) with schizophrenia. The primary endpoint was the
frequency of all adverse events, including serious adverse
events.2
About UZEDY
UZEDY (risperidone) extended-release injectable suspension for
subcutaneous use is indicated for the treatment of schizophrenia in
adults. In clinical trials, UZEDY significantly reduced the risk of
schizophrenia relapse.1,2 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.
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.
See below for additional Important Safety Information.
IMPORTANT SAFETY INFORMATION CONTINUED
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) is a
different kind of global pharmaceutical leader, one that operates
across the full spectrum of innovation to reliably deliver
medicines to patients worldwide. For over 120 years, Teva’s
commitment to bettering health has never wavered. Today, the
company’s global network of capabilities enables its 37,000
employees across 57 markets to advance health by developing
medicines for the future while championing the production of
generics and biologics. If patients have a need, we’re already
working to address it. To learn more about how Teva is all in for
better health, visit 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: our ability to successfully
develop and commercialize UZEDY (risperidone) extended-release
injectable suspension for the maintenance treatment of BP-I in
adult patients; our ability to successfully compete in the
marketplace, including our ability to develop and commercialize
additional pharmaceutical products; our ability to successfully
execute our Pivot to Growth strategy, including to expand our
innovative and biosimilar medicines pipeline and profitably
commercialize the innovative medicines and biosimilar portfolio,
whether organically or through business development, and to sustain
and focus our portfolio of generic medicines; and other factors
discussed in our Annual Report on Form 10-K for the year ended
December 31, 2024, including in the section 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.
- UZEDY® (risperidone) extended-release injectable suspension,
for subcutaneous injection Current Prescribing Information.
Parsippany, NJ. Teva Neuroscience, Inc.
- Data on file. Parsippany, NJ: Teva Neuroscience, Inc.
- Clinicaltrials.gov. Study to Evaluate TV-46000 as Maintenance
Treatment in Adult and Adolescent Participants With Schizophrenia
(RISE). https://clinicaltrials.gov/study/NCT03503318. Accessed
November 2024.
- Merikangas KR, Akiskal HS, Angst J, et al. Lifetime and
12-Month Prevalence of Bipolar Spectrum Disorder in the National
Comorbidity Survey Replication. Arch Gen Psychiatry.
2007;64(5):543–552. doi:10.1001/archpsyc.64.5.543
About Medincell
Medincell is a clinical- and commercial-stage biopharmaceutical
licensing company developing long-acting injectable drugs in many
therapeutic areas. Our innovative treatments aim to guarantee
compliance with medical prescriptions, to improve the effectiveness
and accessibility of medicines, and to reduce their environmental
footprint. They combine active pharmaceutical ingredients with our
proprietary BEPO® technology which controls the delivery of a drug
at a therapeutic level for several days, weeks or months from the
subcutaneous or local injection of a simple deposit of a few
millimeters, entirely bioresorbable. The first treatment based on
BEPO® technology, intended for the treatment of schizophrenia, was
approved by the FDA in April 2023, and is now distributed in the
United States by Teva under the name UZEDY® (BEPO® technology is
licensed to Teva under the name SteadyTeq™). We collaborate with
leading pharmaceutical companies and foundations to improve global
health through new treatment options. Based in Montpellier,
Medincell currently employs more than 140 people representing more
than 25 different nationalities.
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Relations Inquires TevaIR@Tevapharm.com
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