Data support overnight conversion from tetrabenazine to AUSTEDO™ for
the treatment of chorea associated with Huntington disease
JERUSALEM--(BUSINESS WIRE)--Jul. 11, 2017--
Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) and the
Huntington Study Group today announced results from the Phase III
open-label, single-arm switch cohort of the ARC-HD (Alternatives
for Reducing Chorea in HD) study were published in JAMA
Neurology. Results from the study showed patients with chorea
associated with Huntington disease (HD) were able to safely switch
overnight from three times daily tetrabenazine to twice daily AUSTEDO™
(deutetrabenazine) tablets. The ARC-HD study was conducted by Teva in
partnership with the Huntington Study Group.
A rare and fatal neurodegenerative disorder, HD affects approximately
35,000 people in the United States. Chorea – involuntary, random and
sudden, twisting and/or writhing movements – is one of the most striking
physical manifestations of this disease and occurs in approximately 90%
of patients. HD may also manifest as cognitive deterioration and
behavioral and/or psychological problems.
“Chorea is a debilitating symptom of Huntington disease that can impact
the safety, function and quality of life of many patients,” said Michael
Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific
Officer at Teva. “We are pleased to share the ARC-HD study results to
allow those physicians treating HD patients to increase their knowledge
of AUSTEDO™.”
“Human-based research is critical to evolving our understanding of HD
and to providing more options and meaningful treatments,” said Samuel
Frank, M.D., principal investigator of the ARC-HD study and Director of
the Huntington’s Disease Society of America Center of Excellence at Beth
Israel Deaconess Medical Center. “It could not be done without the
dedication of patients and their families who participate in clinical
trials, for which we are extremely grateful.”
The ARC-HD study enrolled 37 patients who had been on a stable
tetrabenazine regimen (≥8 weeks). Patients were converted from
tetrabenazine to an initial AUSTEDO™ daily dose of approximately half
the prior tetrabenazine daily dosage. One week after overnight
conversion to AUSTEDO™, investigators could begin weekly dose
adjustments, if needed, to achieve optimal chorea control. Changes from
baseline in United Huntington’s Disease Rating Scale (UHDRS), Total
Maximal Chorea Score (TMC) and Total Motor Score (TMS) were evaluated as
efficacy endpoints.
For more information regarding this JAMA Neurology publication,
visit http://jamanetwork.com/journals/jamaneurology/fullarticle/2643174.
About AUSTEDO™
Austedo™ is an oral, small molecule inhibitor of vesicular monoamine 2
transporter, or VMAT2, that is designed to regulate the levels of
neurotransmitters in the brain. Austedo™ is approved in the United
States for the treatment of chorea associated with Huntington’s disease.
Important Safety Information
WARNING: DEPRESSION AND SUICIDALITY. AUSTEDOTM can
increase the risk of depression and suicidal thoughts and behavior
(suicidality) in patients with Huntington’s disease. Anyone considering
the use of AUSTEDOTM must balance the risks of
depression and suicidality with the clinical need for treatment of
chorea. AUSTEDOTM is contraindicated in
patients who are suicidal, and in patients with untreated or
inadequately treated depression.
AUSTEDOTM is also contraindicated in: patients with hepatic
impairment; patients taking monoamine oxidase inhibitors (MAOIs), or
within 14 days of discontinuing MAOI therapy; patients taking reserpine
or within 20 days of discontinuing reserpine; and patients taking
tetrabenazine (XENAZINE®). VMAT2 inhibitors, including AUSTEDOTM,
may cause a worsening in mood, cognition, rigidity, and functional
capacity. Neuroleptic Malignant Syndrome has been observed in patients
receiving tetrabenazine (a closely related VMAT2 inhibitor). AUSTEDOTM may
increase the risk of akathisia, agitation, and restlessness and may
cause parkinsonism in patients with Huntington’s disease. Sedation is a
common dose-limiting adverse reaction of AUSTEDOTM.
Tetrabenazine causes an increase in the corrected QT (QTc) interval. A
clinically relevant QT prolongation may occur in some patients treated
with AUSTEDOTM who are CYP2D6 poor metabolizers or are
co-administered a strong CYP2D6 inhibitor. Tetrabenazine elevates serum
prolactin concentrations in humans.
Since deutetrabenazine or its metabolites bind to melanin-containing
tissues, it could accumulate in these tissues over time. The most common
adverse reactions (>8% of AUSTEDOTM-treated patients and
greater than placebo) in a controlled clinical study were: somnolence,
diarrhea, dry mouth, and fatigue. Please click here for full Prescribing
Information, including Boxed Warning: austedo.com/pi.
A copy may be requested from the US Medical Information Contact Center
for Teva Specialty Medicines at 888-4-TEVA-RX (888-483-8279) and USMedInfo@tevapharm.com or
Teva’s Public Relations or Investor Relations contacts.
About Huntington Disease
Huntington disease (HD) is a fatal neurodegenerative disease
characterized by uncoordinated and uncontrollable movements, cognitive
deterioration and behavioral and/or psychological problems. Onset of HD
symptoms typically occurs in middle age, but the disease also manifests
in children and the elderly. HD is the most common genetic cause of
abnormal involuntary writhing movements called chorea.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading
global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions used by approximately 200 million
patients in 100 markets every day. Headquartered in Israel, Teva is the
world’s largest generic medicines producer, leveraging its portfolio of
more than 1,800 molecules to produce a wide range of generic products in
nearly every therapeutic area. In specialty medicines, Teva has the
world-leading innovative treatment for multiple sclerosis as well as
late-stage development programs for other disorders of the central
nervous system, including movement disorders, migraine, pain and
neurodegenerative conditions, as well as a broad portfolio of
respiratory products. Teva is leveraging its generics and specialty
capabilities in order to seek new ways of addressing unmet patient needs
by combining drug development with devices, services and technologies.
Teva's net revenues in 2016 were $21.9 billion. For more information,
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
regarding deutetrabenazine, 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
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relating to:
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specialty products, especially Copaxone®, our
leading medicine, which faces competition from existing and potential
additional generic versions and orally-administered alternatives; our
ability to achieve expected results from investments in our product
pipeline; competition from companies with greater resources and
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develop and commercialize additional pharmaceutical products;
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Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
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