* In a new cohort of 27 adults from the IMPACT-TD Registry, up to 77% of
participants reported improvements in aspects of their lives impacted by
tardive dyskinesia (TD) while taking AUSTEDO or AUSTEDO XR
* Most (85%) participants taking AUSTEDO or AUSTEDO XR in conjunction with
their mental health medications reported that their mental health condition
remained stable or improved
* Teva is committed to truly understanding and empowering individuals living
with TD to help improve their TD and regain their independence
PARSIPPANY, N.J., and TEL AVIV, Israel, Nov. 07, 2025 (GLOBE NEWSWIRE) -- Teva
Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE
and TASE: TEVA), today announced the presentation of new data from the ongoing,
real-world IMPACT-TD Registry. The findings demonstrate that treatment with
AUSTEDO (deutetrabenazine) tablets or AUSTEDO XR (deutetrabenazine) extended-
release tablets for tardive dyskinesia (TD) led to reductions in the severity of
involuntary movements and improvements in patient-reported quality of life. The
data were presented at the 2025 Neuroscience Education Institute Fall Congress,
taking place November 6 - 9, 2025 in Colorado Springs, Colorado.
"The silent struggle of tardive dyskinesia, with its relentless, involuntary
movements, can deprive patients of their quality of life and independence-real-
world findings are so critical to inform how we innovate and improve the
everyday lives of individuals living with this disease," said Stacy Finkbeiner,
Senior Medical Director, Movement Disorders & Psychiatry at Teva. "These data
articulate patient experience and further validate clinical research showing how
AUSTEDO or AUSTEDO XR can help people living with tardive dyskinesia improve
their symptoms while maintaining their mental health, something we care deeply
about in our mission at Teva to improve the lives of patients."
The interim analysis of the IMPACT-TD Registry, a Phase 4 study, evaluated 27
adults with TD treated with AUSTEDO or AUSTEDO XR after a three-month period
using IMPACT-TD PRO, a 30-question scale measuring patient-reported impact
across 5 key areas. The study included patients with common comorbid psychiatric
disorders, such as bipolar disorder (41%), anxiety disorder (37%), depression
(26%), and schizophrenia (19%), reflecting a diverse, real-world patient
population.
Key results revealed:
* Patient-reported meaningful improvement after three months on AUSTEDO or
AUSTEDO XR across several areas, including speech/communication (77%),
eating (75%), psychosocial impact (65%), activities of daily living (59%),
and sleep/pain (50%).
* At three months, the total motor score on the Abnormal Involuntary Movement
Scale (AIMS) showed a mean decrease of -2.9, indicating a notable reduction
in the severity of uncontrolled movements consistent with what was
previously seen in pivotal trials.
* Most (85%) participants taking AUSTEDO or AUSTEDO XR in conjunction with
their mental health medications reported that their underlying mental health
condition remained stable or improved based on the Patient Global Impression
of Severity (PGIS) scale.
While Part A of the IMPACT-TD Registry demonstrated the broad impact TD has on
individuals beyond physical movements, these initial findings from Part B
reflect patient-reported improvements in everyday tasks like speaking, eating,
and other activities of daily living as a result of movement reduction with
AUSTEDO or AUSTEDO XR.
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
(https://www.austedo.com/globalassets/austedo/prescribing-information.pdf),
including Boxed Warning.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading
innovative biopharmaceutical company, enabled by a world-class generics
business. For over 120 years, Teva's commitment to bettering health has never
wavered. From innovating in the fields of neuroscience and immunology to
providing complex generic medicines, biosimilars and pharmacy brands worldwide,
Teva is dedicated to addressing patients' needs, now and in the future. At Teva,
We Are All In For Better Health. To learn more about how, visit
www.tevapharm.com (https://www.tevapharm.com/).
Teva 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 other factors discussed
in our Quarterly Report on Form 10-Q for the third quarter of 2025 and 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.
References:
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.
Teva Media Inquiries TevaCommunicationsNorthAmerica@tevapharm.com
(mailto:TevaCommunicationsNorthAmerica@tevap
harm.com)
Teva Investor Relations Inquiries TevaIR@Tevapharm.com
(mailto:TevaIR@Tevapharm.com)
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