Phase 3
RISE study evaluated treatment with TV-46000, a subcutaneous
long-acting injectable risperidone formulation
New data
showed TV-46000 decreased risk of relapse and increased chance of
clinical stability versus placebo in patients with
schizophrenia
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical
Industries Ltd. (NYSE and TASE: TEVA), today announced results from
the pivotal Phase 3 Risperidone Subcutaneous
Extended-release (RISE) study comparing TV-46000/mdc-IRM
once monthly (q1m) and TV-46000/mdc-IRM once every two months (q2m)
with placebo (1:1:1) in patients with schizophrenia who underwent
stabilization on oral risperidone. Results showed treatment with
TV-46000 (overall, q1m or q2m) significantly prolonged time to
relapse, decreased proportions of patients with impending relapse
at week 24 and demonstrated significant increase in proportions
maintaining stability. The safety profile of TV-46000, as
demonstrated in this study, is consistent with other formulations
of risperidone. The most common adverse reactions (≥5% and greater
than placebo) were nasopharyngitis, increased weight, and
extrapyramidal disorder. These findings, among others, were
presented during the poster session at the 2021 Psych Congress
Annual Meeting taking place Oct. 29-Nov. 1, 2021 in San Antonio, TX
(in addition to virtual participation).
Schizophrenia is a chronic and severe mental disorder1
characterized by distortions in thinking, perception, emotions,
language, sense of self and behavior.2 Twenty million people
worldwide are affected by schizophrenia1, often living with
considerable disability.2 Currently, about 70% of people living
with schizophrenia are not receiving appropriate care3 despite the
treatability of the illness.2
“Relapse rates among people living with schizophrenia are quite
staggering, ranging between 50 and 92% globally.4,5 It is crucial
to provide patients and prescribers with treatment options that
have the potential to reduce relapse rates to help manage and
stabilize the disease over time,” said Eran Harary, MD, VP Global
Head of Specialty R&D at Teva. “Coming off the heels of the
recent FDA acceptance of our New Drug Application, we’re proud to
be sharing our Phase 3 data at this year’s Psych Congress. We are
committed to investigating the full potential of our subcutaneous
long-acting injectable (LAI) formulation of risperidone for the
treatment of this complex and burdensome illness.”
“When managing schizophrenia, it is crucial to have treatment
options that work to reduce the risk of relapse. As researchers,
physicians and providers, we must work together to address this,”
said John Kane, MD, Professor and Chairman, Department of
Psychiatry, The Donald and Barbara Zucker School of Medicine at
Hofstra/Northwell and RISE lead investigator. “These latest data
from the Phase 3 RISE study are quite encouraging for both patients
and providers.”
Efficacy and Safety of Subcutaneous Risperidone Injectable
(TV-46000) in Patients With Schizophrenia: A Phase 3, Randomized,
Double-Blind, Placebo-Controlled, Relapse Prevention Study (RISE
Study) The Phase 3 RISE study was designed to compare TV-46000
q1m and TV-46000 q2m with placebo (1:1:1 ratio; stage 2) in
patients with schizophrenia who underwent stabilization on oral
risperidone (stage 1). The primary endpoint was time to impending
relapse and secondary endpoints included proportions of patients
with impending relapse at week 24 and proportions of patients who
maintained stability at week 24. No new safety signals were
identified with TV-46000 versus accumulated safety data of oral
risperidone and other long-acting risperidone formulations.
Out of 1267 patients screened, 863 were enrolled and 544 were
randomized. Time to impending relapse significantly favored
TV-46000 (hazard ratio [95% CI]; overall: 0.283 [0.184, 0.435],
P<.0001; q1m: 0.200 [0.109, 0.367], P<.0001; q2m: 0.375
[0.227, 0.618], P<.0001) versus placebo. TV-46000 also prolonged
time to relapse by 3.5, 5.0 and 2.7 times, respectively, versus
placebo. Proportions of patients with impending relapse at week 24
were significantly lower for TV‑46000 (overall: 9%; q1m: 7%; q2m:
11%) versus placebo (28%; P<.0001, P<.0001, P=.0001,
respectively). Proportions of patients maintaining stability were
significantly higher (83%, 87%, 80% vs 61%; P<.0001, P<.0001,
P=.0001, respectively). The safety profile of TV-46000, as observed
in this study, is consistent with other formulations of
risperidone. The most common adverse reactions (≥5% and greater
than placebo) were nasopharyngitis, increased weight, and
extrapyramidal disorder.
About TV46000-CNS-30072 (The RISE Study – The Risperidone
Subcutaneous Extended-Release Study) The RISE 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. 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.
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 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 specialty 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 specialty 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 of
risperidone LAI; our ability to successfully compete in the
marketplace, including our ability to develop and commercialize
biopharmaceutical products, competition for our specialty products,
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; our business and operations in general, including
uncertainty regarding the COVID-19 pandemic and its impact on our
business, financial condition, operations, cash flows, and
liquidity and on the economy in general, our ability to
successfully execute and maintain the activities and efforts
related to the measures we have taken or may take in response to
the COVID-19 pandemic and associated costs therewith, costs and
delays resulting from the extensive pharmaceutical regulation to
which we are subject or delays in governmental processing time due
to travel and work restrictions caused by the COVID-19 pandemic;
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
Annual Report on Form 10-K for the year ended December 31, 2020,
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 GBD 2017 Disease and
Injury Incidence and Prevalence Collaborators. Global, regional,
and national incidence, prevalence, and years lived with disability
for 354 diseases and injuries for 195 countries and territories,
1990–2017: a systematic analysis for the Global Burden of Disease
Study 2017. [published correction appears in Lancet. 2019 Jun
22;393 (10910):e44]. Lancet. 2018;392 (10159): 1789-1858. 2 World
Health Organization. Schizophrenia.
www.who.int/news-room/fact-sheets/detail/schizophrenia. Accessed on
October 4, 2021. 3 Lora A, et al. Service availability and
utilization and treatment gap for schizophrenic disorders: a survey
in 50 low- and middle-income countries. Bulletin of the World
Health Organization. 90 (1), 47-54B. World Health Organization.
http://dx.doi.org/10.2471/BLT.11.089284 4Cernansky JG, Schuchart
EK. Relapse and rehospitalisation rates in patients with
schizophrenia: effects of second generation antipsychotics CNS
Drugs. 2002;16(7):473–484. 5Weret ZS, Mukherjee R. Prevalence of
relapse and associated factors in patient with schizophrenia at
Amanuel Mental Specialized Hospital, Addis Ababa, Ethiopia:
institution based cross sectional study. International Journal of
Interdisciplinary and Multidisciplinary Studies. 2014, Vol 2, No.1,
184-192.
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IR United States Kevin C. Mannix (215) 591-8912 Yael
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PR United States Yonatan Beker (973) 917-0851
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