- Nearly 98% of patients experience quality of life impact as
a result of tardive dyskinesia (TD) including social,
psychological, physical and recreational aspects of daily
living
- Data highlight for the first time that TD has a
multidimensional impact on patients including those with mild TD
severity
- IMPACT-TD Registry is the largest-ever study of its kind
evaluating the holistic effects of TD over three years along with
real-world treatment patterns and outcomes with once-daily AUSTEDO®
XR (deutetrabenazine) extended-release tablets and twice-daily
AUSTEDO® (deutetrabenazine) tablets
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical
Industries Ltd. (NYSE and TASE: TEVA), today announced new patient-
and physician-reported interim results from the Phase 4 IMPACT-TD
Registry study, reinforcing that TD has a wide-reaching,
multidimensional impact on patients’ quality of life. These interim
findings from the IMPACT-TD study were presented at the 2024 Psych
Congress Elevate Annual Meeting, taking place from May 30 – June 2
in Las Vegas, Nevada.
“TD can be a devastating setback for those who have achieved
mental stability with their psychiatric medication,” said Eric
Hughes, MD, PhD, Executive Vice President of Global R&D and
Chief Medical Officer at Teva. “These interim findings from
IMPACT-TD Registry, the largest study of its kind, reveal the
profound effect that TD can have on a patient’s life, beyond the
clinic. Understanding the full impact of TD and how approved
treatment options for TD, like once-daily AUSTEDO XR and
twice-daily AUSTEDO, can help treat the condition is critical to
improving outcomes for patients and is a driving force in our
unwavering commitment to developing meaningful solutions for
them.”
The two-part IMPACT-TD study is a 3-year longitudinal
observational study evaluating how TD progresses over time and
impacts a patient’s quality of life (Part A), as well as outcomes
related to treatment with once-daily AUSTEDO XR and twice-daily
AUSTEDO (Part B).
Clinician-reported TD severity and impact is assessed using the
IMPACT-TD scale, the AIMS (Abnormal Involuntary Movement Scale) and
the CGIS-TD (Clinical Global Impression of Severity of TD) scale.
The interim analysis includes 286 patients with varying levels of
TD severity and highlights, for the first time, that clinicians
reported that TD has a multidimensional impact, even on patients
with mild TD severity. Clinician-reported IMPACT-TD findings
show:
- 98% of patients experience the impact of TD in some aspect of
their quality of life
- 83% of patients experience moderate to severe impact across
various quality of life domains, including social (59%),
psychological/psychiatric (70%), physical (53%) and
vocational/educational/recreational (57%)
- 54% and 61% of patients with “very mild” and “mild” TD severity
based on CGIS-TD, respectively, experience moderate to severe
impact on their quality of life
Patient-reported TD impact is assessed using the novel IMPACT-TD
PRO (IMPACT-TD Patient-Reported Outcome) scale. Patient-reported
findings, as assessed with the IMPACT-TD PRO, show:
- 59% and 57% of patients reported that TD caused embarrassment
in social situations and impacted their ability to enjoy the things
they do for fun, respectively
- 43% of patients reported that TD impacts their sleep
- 38-42% of patients reported experiencing the physical impact of
TD, including on their ability to hold things, do chores and
exercise
“These data provide a clearer understanding as to how the
abnormal movements of TD significantly impact the daily functioning
of patients that cannot be gleaned from looking solely at the
severity of the movements,” said Richard Jackson, MD, an Assistant
Clinical Adjunct Professor in the University of Michigan School of
Medicine’s Department of Psychiatry and the study’s lead
investigator. “TD can impact all domains of daily functioning
including social, psychological, physical, occupational and
recreational aspects of daily living even when the abnormal
movements appear to be mild. This emphasizes the need for all
clinicians to assess not only the severity of a patient’s TD
movements but the impact those movements can have on all aspects of
life. Continuing to understand the multifaceted impact of TD and
finding ways to alleviate these burdens is crucial to supporting
patients on their TD journey.”
Also presented at Psych Congress Elevate 2024 were data
supporting:
- The development and internal validation of the IMPACT-TD PRO
scale, suggesting that the questionnaire can effectively and
reliably characterize the multidimensional impact of TD in adult
patients.
- Final results from the TD cohort of the Phase 4 START study,
which investigated real-world treatment outcomes for patients
starting AUSTEDO with the 4-week Titration Kit. These full START
results show that the titration kit successfully helped patients
with TD find individualized therapeutic AUSTEDO doses with
effectiveness similar to that observed in the pivotal clinical
trials, with high adherence and patient satisfaction rates.
- Findings from a retrospective study comparing healthcare
resource utilization (HCRU) in patients with TD treated with
benztropine versus non-treated patients with TD suggest that
benztropine can result in potential harm and increased cost for the
patient if used off-label for the treatment of TD.
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.1,2,3
About AUSTEDO XR Extended-Release Tablets and AUSTEDO
Tablets AUSTEDO XR and AUSTEDO are the first vesicular
monoamine transporter 2 (VMAT2) inhibitors approved by the U.S.
Food and Drug Administration in adults for the treatment of tardive
dyskinesia and for the treatment of chorea associated with
Huntington’s disease. Safety and effectiveness in pediatric
patients have not been established. AUSTEDO XR is the once-daily
formulation of AUSTEDO.
INDICATIONS AND USAGE AUSTEDO XR (deutetrabenazine)
extended-release tablets and AUSTEDO (deutetrabenazine) tablets are
indicated in adults for the treatment of chorea associated with
Huntington’s disease and for the treatment of tardive
dyskinesia.
IMPORTANT SAFETY INFORMATION
Depression and Suicidality in Patients with Huntington’s
Disease: AUSTEDO XR and 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 XR and AUSTEDO are contraindicated in patients
who are suicidal, and in patients with untreated or inadequately
treated depression.
Contraindications: AUSTEDO XR and AUSTEDO are
contraindicated in patients with Huntington’s disease who are
suicidal, or have untreated or inadequately treated depression.
AUSTEDO XR and AUSTEDO are 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 or valbenazine.
Clinical Worsening and Adverse Events in Patients with
Huntington’s Disease: AUSTEDO XR and AUSTEDO may cause a
worsening in mood, cognition, rigidity, and functional
capacity. Prescribers should periodically re-evaluate the
need for AUSTEDO XR or AUSTEDO in their patients by assessing the
effect on chorea and possible adverse effects.
QTc Prolongation: AUSTEDO XR and AUSTEDO may prolong the
QT interval, but the degree of QT prolongation is not clinically
significant when AUSTEDO XR or AUSTEDO is administered within the
recommended dosage range. AUSTEDO XR and 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 XR and AUSTEDO;
intensive symptomatic treatment and medical monitoring; and
treatment of any concomitant serious medical problems.
Akathisia, Agitation, and Restlessness: AUSTEDO XR and
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 XR or AUSTEDO dose should be
reduced; some patients may require discontinuation of therapy.
Parkinsonism: AUSTEDO XR and 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 XR or 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 XR and 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 XR or 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 XR and 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. Adverse reactions with AUSTEDO
XR extended-release tablets are expected to be similar to AUSTEDO
tablets.
Please see accompanying full Prescribing Information, including
Boxed Warning.
About Teva Teva Pharmaceutical Industries Ltd. (NYSE and
TASE: TEVA) is a global pharmaceutical leader with a
category-defying portfolio, harnessing our generics expertise and
stepping up innovation to continue the momentum behind the
discovery, delivery, and expanded development of modern medicine.
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 58 markets to push the
boundaries of scientific innovation and deliver quality medicines
to help improve health outcomes of millions of patients every day.
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
AUSTEDO and AUSTEDO XR for the treatment of tardive dyskinesia and
for the treatment of chorea associated with Huntington’s disease;
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
generics medicines; and other factors discussed in our Quarterly
Report on Form 10-Q for the first quarter of 2024 and in our Annual
Report on Form 10-K for the year ended December 31, 2023, 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 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. 2 Waln O, Jankovic J. An Update on Tardive
Dyskinesia: From Phenomenology to Treatment. Tremor Other
Hyperkinet Mov. 2013;3:1-11. 3 Tardive dyskinesia. National
Alliance on Mental Illness website.
https://www.nami.org/Learn-More/Treatment/Mental-Health-Medications/Tardive-Dyskinesia.
Accessed May 4, 2023.
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PR Contacts Kelley Dougherty +1 (973) 832-2810
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Ran Meir +1 (267) 468-4475
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