TEL AVIV, Israel and
PARSIPPANY, N.J., May 17, 2021 /PRNewswire/ -- Teva
Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries
Ltd. (NYSE: TEVA) (TASE: TEVA), today announced the launch of
It's Not OK – It's TD, a new national television advertising
campaign, which aims to inspire patients with tardive dyskinesia
(TD) symptoms to speak up and share the impact of TD with their
healthcare provider, start working together to manage their
symptoms rather than coping, and ask about how treatment with
AUSTEDO® (deutetrabenazine) tablets may help.
Encouraging patients to say, 'It's not OK,' the ad drives awareness
of AUSTEDO, a prescription medicine that may help manage TD while
patients continue their mental health medication(s) like
antipsychotics or antidepressants.
Tardive dyskinesia is associated with certain prescription
medicines used to treat mental health or gastrointestinal
conditions.1,2 One in four people who take certain
mental health treatments may develop the uncontrollable movements
of TD, including mild-to-severe twitching, shaking or jerking of
hands, feet, face or torso, and more. Whether symptoms are mild,
moderate, or severe, the impact of TD can be significant, causing
physical changes that may lead to functional and emotional
changes.1,2,3
"As we navigate through a global pandemic, we know there is an
increase in individuals reporting symptoms of anxiety or depressive
disorder," said Brendan O'Grady,
Executive Vice President and Head of North America Commercial at
Teva. "Now more than ever, it is important to elevate our efforts
to support individuals with TD and mental health conditions. We
developed the 'It's Not OK – It's TD' campaign based on valuable
insights from patients with TD, allowing us to put a much needed
and authentic spotlight on the disorder and how it can truly impact
well-being, while driving education about AUSTEDO as a treatment
that may help manage their TD symptoms."
People living with mental health conditions often feel
stigmatized and delay seeking treatment.4 For some
patients, finding the right combination of mental health
medications can take several years, and some living with TD would
rather cope with their movements than alter their existing
treatment regimen and risk relapse.5,6,7
"TD is already under-diagnosed and under-treated, and with
increasing telemedicine visits, it is more challenging to visually
identify TD movements, leaving patients to continue coping with the
physical and emotional impact of their symptoms," said Rakesh Jain, MD, MPH, Clinical Professor,
Department of Psychiatry, Texas Tech Health Sciences Center School
of Medicine, Midland. "For patients with mental health conditions,
it's critical that we initiate open discussions about their
experience with TD and in managing it, we don't take away from
their progress and related treatment plan. I'm pleased AUSTEDO can
help patients manage their TD symptoms without affecting their
mental health treatment regimens."
In one clinical study, AUSTEDO significantly reduced the
involuntary movements of TD after 12 weeks of treatment vs.
placebo, with improvement beginning to be seen as early as 2 weeks.
Additionally, in an open label extension study—the longest TD study
to date—symptom control was sustained through 145 weeks, and no new
adverse events were observed compared to those in pivotal trials.
The most common side effects of AUSTEDO include inflammation of the
nose and throat (nasopharyngitis) and problems sleeping
(insomnia).8,9,10
Several informational resources are available on AUSTEDO.com to
help individuals throughout the entire process—from learning more
about TD to starting and staying on course with treatment:
- TD doctor discussion guide and symptom questionnaire for
in-person or telemedicine visits
- AUSTEDO patient brochure
- Daily treatment and activity log to better guide patient
discussions with their healthcare provider
- AUSTEDO treatment tracking guide to help establish a dosing
routine and taking medication as prescribed by the provider
Additionally, Teva's Shared Solutions® program is
committed to partnering with patients throughout their treatment
with AUSTEDO. This includes financial assistance programs where a
dedicated team of benefits specialists can help eligible patients
gain access to AUSTEDO as soon as possible through:
- AUSTEDO® Copay Program, where eligible commercially
insured patients may receive the treatment for as little as
$0 copay per month
- Assistance with navigating through Medicare Part D
- Additional financial assistance programs that may exist
depending on insurance coverage and meeting eligibility
requirements
The program's nurse phone support also allows patients to
connect with trained nurses to discuss their treatment.
To view the new commercial, please visit YouTube and
visit Austedo.com/tardive-dyskinesia for more information on
TD and the campaign.
About Tardive Dyskinesia (TD)
Tardive dyskinesia (TD)
is associated with certain prescription medications used to treat
mental health or gastrointestinal
conditions.1,2 One in four
people who are taking certain mental health medications may develop
uncontrollable movements of TD. Long-term use of some medications
to treat schizophrenia, bipolar disorder, depression, and some
other conditions can lead to
TD.2,3
TD can appear as mild-to-severe twitching, shaking or jerking in
the hands, feet, face, or torso, involuntary blinking, tongue
movements, and other unintentional movements. The severity of
TD symptoms can vary from person to person, but even mild symptoms
can be bothersome. The unintentional, uncontrollable movements of
TD can impact a person both physically and functionally, making
activities like walking, writing, eating, speaking, or swallowing
difficult.1,2,3
About
AUSTEDO® (deutetrabenazine)
AUSTEDO® is
a vesicular monoamine transporter 2 (VMAT2) inhibitor approved by
the U.S. Food and Drug Administration for the treatment of tardive
dyskinesia in adults and for the treatment of chorea associated
with Huntington's disease. Safety and effectiveness in pediatric
patients have not been established.
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 regarding AUSTEDO, 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. Important factors that could cause or
contribute to such differences include risks relating to:
- the commercial success of AUSTEDO;
- our ability to successfully compete in the marketplace,
including: that we are substantially dependent on our generic
products; consolidation of our customer base and commercial
alliances among our customers; delays in launches of new generic
products; the increase in the number of competitors targeting
generic opportunities and seeking U.S. market exclusivity for
generic versions of significant products; 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, which may limit our ability to
incur additional indebtedness, engage in additional transactions or
make new investments, may result in a further downgrade of our
credit ratings; and our inability to raise debt or borrow funds in
amounts or on terms that are favorable to us;
- 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; effectiveness of our optimization
efforts; our ability to attract, hire and retain highly skilled
personnel; manufacturing or quality control problems; interruptions
in our supply chain; disruptions of information technology systems;
breaches of our data security; variations in intellectual property
laws; challenges associated with conducting business globally,
including political or economic instability, major hostilities or
terrorism; 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; the effects of reforms in
healthcare regulation and reductions in pharmaceutical pricing,
reimbursement and coverage; significant sales to a limited number
of customers; our ability to successfully bid for suitable
acquisition targets or licensing opportunities, or to consummate
and integrate acquisitions; and our prospects and opportunities for
growth if we sell assets;
- compliance, regulatory and litigation matters, including:
failure to comply with complex legal and regulatory environments;
increased legal and regulatory action in connection with public
concern over the abuse of opioid medications and our ability to
reach a final resolution of the remaining opioid-related
litigation; scrutiny from competition and pricing authorities
around the world, including our ability to successfully defend
against the U.S. Department of Justice criminal charges of Sherman
Act violations; potential liability for patent infringement;
product liability claims; failure to comply with complex Medicare
and Medicaid reporting and payment obligations; compliance with
anti-corruption sanctions and trade control laws; and environmental
risks;
- other financial and economic risks, including: our exposure to
currency fluctuations and restrictions as well as credit risks;
potential impairments of our intangible assets; potential
significant increases in tax liabilities (including as a result of
potential tax reform in the United
States); and the effect on our overall effective tax rate of
the termination or expiration of governmental programs or tax
benefits, or of a change in our business;
and other factors discussed in this press release and in our
Quarterly Report on Form 10-Q for the first quarter of 2021 and in
our Annual Report on Form 10-K for the year ended December 31, 2020, including in the sections
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.
1 Warikoo N, Schwartz T, Citrome L. Tardive
dyskinesia. In: Schwartz TL, Megna J, Topel ME,
eds. Antipsychotic Drugs: Pharmacology, Side Effects and
Abuse Prevention. Hauppauge,
NY: Nova Science Publishers, Inc; 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 National Alliance on Mental Illness (NAMI). Tardive
Dyskinesia. Accessed April 2021.
https://www.nami.org/About-Mental-Illness/Treatments/Mental-Health-Medications/Tardive-Dyskinesia.
4 American Psychiatric Association. Stigma,
Prejudice and Discrimination Against People with Mental Illness.
APA website. Accessed April 2021.
https://www.psychiatry.org/patients-families/stigma-and-discrimination.
5 International Bipolar Foundation. Finding the
Right Medication. Accessed April
2021.
https://ibpf.org/articles/finding-the-right-medication/#:~:text=Be%20patient%20as%20it%20can,you%20find%20the%20right%20balance.
6 Caroff SN. Overcoming barriers to effective
management of tardive dyskinesia. Neuropsychiatr Dis
Treat. 2019;15:785-794.
7 Fernandez HH, Stamler D, Davis MD, et al.
Long-term safety and efficacy of deutetrabenazine for the treatment
of tardive dyskinesia. J Neurol Neurosurg
Psychiatry. 2019;90(12):1317-1323.
8 AUSTEDO® (deutetrabenazine) tablets
current Prescribing Information. Parsippany, NJ. Teva Neuroscience,
Inc.
9 Data on file. Parsippany, NJ. Teva Neuroscience, Inc.
10 Anderson KE, Stamler D, Davis MD, et al.
Deutetrabenazine for treatment of involuntary movements in patients
with tardive dyskinesia (AIM-TD): a double-blind, randomised,
placebo-controlled, phase 3 trial. Lancet Psychiatry.
2017;4(8):595-604.
IR
Contacts
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States
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Mannix
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(215)
591-8912
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SOURCE Teva Pharmaceutical Industries Ltd