Findings evaluate efficacy and safety of
AUSTEDO in postmenopausal women with tardive dyskinesia (TD) for up
to 3 years
Two studies evaluate the psychological, social
and physical impact of TD on U.S. patients and caregivers
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical
Industries Ltd. (NYSE and TASE: TEVA), today announced new efficacy
and safety data from a 3-year open-label extension (OLE) study on
AUSTEDO® (deutetrabenazine) tablets in postmenopausal women with
tardive dyskinesia (TD). These data will be presented at the 2022
American Psychiatric Association (APA) Annual Meeting, held May
21-25 in New Orleans and online June 7-10. In addition, new data
assessing the psychological, social and physical impact of TD on
patients and caregivers will also be featured in two posters at
APA.
“TD is a persistent and often debilitating disorder that can be
disruptive to patients in their daily lives. These studies offer
important insights about TD, notably that long-term treatment with
AUSTEDO demonstrated improvements in symptoms in postmenopausal
women, an at-risk population for TD,” said Denisa Hurtukova, MD,
VP, Head of North America Medical Affairs. “Furthermore, findings
from two additional studies being presented at APA show TD symptoms
can significantly impact patients’ emotional and social health and
daily functioning. Healthcare providers should routinely screen
patients to better understand their disease burden.”
Long-Term Efficacy and Safety of AUSTEDO in Postmenopausal
Women with TD In a post-hoc analysis of the long-term OLE study
of AUSTEDO, 137 women with TD who were postmenopausal were
evaluated to determine the efficacy and safety of AUSTEDO in this
patient population. The analysis found AUSTEDO provided
improvements in TD-related movements in postmenopausal women.
Key Findings
- Mean change in total motor Abnormal Involuntary Movement Scale
(AIMS) score, a clinician-rated assessment tool, was –4.5 ± 0.42
and –7.2 ± 0.52 at Week 15 (n=123) and Week 145 (n=77),
respectively .
- A majority of patients showed improvement across two patient
outcome measures, Patient Global Impression of Change (PGIC), and
Clinical Global Impression of Change (CGIC):
- For PGIC, 61% and 68% of patients showed improvement at Week 15
and Week 145, respectively.
- For CGIC, 63% and 82% of patients achieved “much improved” or
“very improved” ratings at Week 15 and Week 145, respectively.
- AUSTEDO safety findings were consistent with findings from the
overall OLE study population (n=337), with no new safety concerns
from long-term treatment.
- Poster [P5-034]: Long-Term Efficacy and Safety of
Deutetrabenazine in Postmenopausal Women with Tardive
Dyskinesia
Psychological, Social and Physical Impact of TD The
physical, psychological and social impact of TD was examined in two
studies that assessed the burden and stigma of TD, regardless of
the underlying condition, from the perspectives of both patients
and caregivers in the U.S.
Data were collected from a literature review and two online
surveys conducted among 269 patients with TD and 162 caregivers.
Impact was measured across different domains over the previous
seven days in all categories. Findings demonstrate that TD has a
significant psychological and social impact on patients and the
patient experience can provide insight into stigma associated with
TD.
Key Findings-Psychological & Social Impact
- Over half of patients (51.3%-58.7%) reported often/always
feeling psychological impacts of TD, such as low self-esteem, fear
of being rejected, being anxious/worried, being embarrassed, and
being irritable/frustrated/angry.
- Caregivers rated low self-esteem, fear of being rejected, and
being unable to focus as having a higher impact on patients.
- For social domains, 48.7%-55.8% of patients reported TD
often/always impacted their ability to socialize with friends and
join social activities, take public transportation, and appear on
video, among other domains.
- Caregivers rated joining social activities, running errands and
taking public transportation as having a higher social impact on
patients.
- Over half (51.6%–68.0%) of patients reported being bothered
quite a bit/very much by reactions from spouses, children,
classmates or colleagues.
- Poster [P7-083]: Impact of Tardive Dyskinesia on
Psychological and Social Aspects of Patient Lives: A Survey of
Patients and Caregivers in the United States
Key Findings-Physical Impact
- Over 90% of patients reported TD impacted physical functioning,
with over two-thirds reporting moderate-to-severe impact on 15 of
24 impact measures, including: ability to fall asleep (86.3%),
ability to exercise and do household chores (77%, 76.6%), ability
to hold items such as glass or fork (76.3%), worry about choking
(76.2%), and feeling self-conscious about speech difficulties
(74.8%).
- Caregivers rated ability to fall asleep, do household chores
and work due to speech difficulties, as having a greater impact;
and worry about choking and trouble eating because of choking as
having a lower impact.
- These findings demonstrate that TD has a substantial burden on
patients’ physical functioning regardless of the underlying
condition, and reinforce the need for healthcare providers to
routinely assess the impact of TD symptoms on eating, speaking,
sleeping, and other activities of daily living.
- Poster [P7-082]: Impact of Tardive Dyskinesia on Physical
Aspects of Patient Lives: A Survey of Patients and Caregivers in
the United States
Posters are available online and can be accessed via the APA
meeting website at: www.psychiatry.org/annualmeeting.
AUSTEDO® Indications and Usage
AUSTEDO® is indicated for the treatment of chorea associated
with Huntington’s disease and for the treatment of tardive
dyskinesia in adults.
Important Safety Information About AUSTEDO®
Depression and Suicidality in Patients with Huntington’s
Disease: AUSTEDO® can increase the risk of depression and
suicidal thoughts and behavior (suicidality) in patients with
Huntington’s disease. Balance the risks of depression and
suicidality with the clinical need for treatment of chorea.
Closely monitor patients for the emergence or worsening of
depression, suicidality, or unusual changes in behavior. Inform
patients, their caregivers, and families of the risk of depression
and suicidality and instruct them to report behaviors of concern
promptly to the treating physician. Exercise caution when treating
patients with a history of depression or prior suicide attempts or
ideation. AUSTEDO® is contraindicated in patients who are suicidal,
and in patients with untreated or inadequately treated
depression.
Contraindications: AUSTEDO® is contraindicated in
patients with Huntington’s disease who are suicidal, or have
untreated or inadequately treated depression. AUSTEDO® is also
contraindicated in: patients with hepatic impairment; patients
taking reserpine or within 20 days of discontinuing reserpine;
patients taking monoamine oxidase inhibitors (MAOIs), or within 14
days of discontinuing MAOI therapy; and patients taking
tetrabenazine (Xenazine®) or valbenazine (Ingrezza®).
Clinical Worsening and Adverse Events in Patients with
Huntington’s Disease: AUSTEDO® may cause a worsening in
mood, cognition, rigidity, and functional capacity.
Prescribers should periodically re-evaluate the need for
AUSTEDO® in their patients by assessing the effect on chorea
and possible adverse effects.
QTc Prolongation: AUSTEDO may prolong the QT interval,
but the degree of QT prolongation is not clinically significant
when AUSTEDO is administered within the recommended dosage range.
AUSTEDO should be avoided in patients with congenital long QT
syndrome and in patients with a history of cardiac arrhythmias.
Neuroleptic Malignant Syndrome (NMS), a potentially fatal
symptom complex reported in association with drugs that reduce
dopaminergic transmission, has been observed in patients receiving
tetrabenazine. The risk may be increased by concomitant use of
dopamine antagonists or antipsychotics. The management of NMS
should include immediate discontinuation of AUSTEDO®;
intensive symptomatic treatment and medical monitoring; and
treatment of any concomitant serious medical problems.
Akathisia, Agitation, and Restlessness: AUSTEDO® may
increase the risk of akathisia, agitation, and restlessness. The
risk of akathisia may be increased by concomitant use of dopamine
antagonists or antipsychotics. If a patient develops akathisia, the
AUSTEDO® dose should be reduced; some patients may require
discontinuation of therapy.
Parkinsonism: AUSTEDO® may cause parkinsonism in patients
with Huntington’s disease or tardive dyskinesia. Parkinsonism has
also been observed with other VMAT2 inhibitors. The risk of
parkinsonism may be increased by concomitant use of dopamine
antagonists or antipsychotics. If a patient develops parkinsonism,
the AUSTEDO® dose should be reduced; some patients may require
discontinuation of therapy.
Sedation and Somnolence: Sedation is a common
dose-limiting adverse reaction of AUSTEDO®. Patients should not
perform activities requiring mental alertness, such as operating a
motor vehicle or hazardous machinery, until they are on a
maintenance dose of AUSTEDO® and know how the drug affects them.
Concomitant use of alcohol or other sedating drugs may have
additive effects and worsen sedation and somnolence.
Hyperprolactinemia: Tetrabenazine elevates serum
prolactin concentrations in humans. If there is a clinical
suspicion of symptomatic hyperprolactinemia, appropriate laboratory
testing should be done and consideration should be given to
discontinuation of AUSTEDO®.
Binding to Melanin-Containing Tissues: Deutetrabenazine
or its metabolites bind to melanin-containing tissues and could
accumulate in these tissues over time. Prescribers should be aware
of the possibility of long-term ophthalmologic effects.
Common Adverse Reactions: The most common adverse
reactions for AUSTEDO® (>8% and greater than placebo) in a
controlled clinical study in patients with Huntington’s disease
were somnolence, diarrhea, dry mouth, and fatigue. The most common
adverse reactions for AUSTEDO® (4% and greater than placebo) in
controlled clinical studies in patients with tardive dyskinesia
were nasopharyngitis and insomnia.
Please see accompanying full Prescribing Information,
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 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 and commercial success of AUSTEDO; 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 the governmental and societal responses
thereto; 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 Quarterly Report on Form 10-Q
for the first quarter of 2022 and in our Annual Report on Form 10-K
for the year ended December 31, 2021, 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.
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IR Contacts United States Ran Meir (267) 468-4072 Yael
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