TEL AVIV, Israel and PARSIPPANY, N.J., Might 17, 2021 /PRNewswire/ — Teva Prescription drugs, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) (TASE: TEVA), at the moment introduced the launch of It is Not OK – It is TD, a brand new nationwide tv promoting marketing campaign, which goals to encourage sufferers with tardive dyskinesia (TD) signs to talk up and share the affect of TD with their healthcare supplier, begin working collectively to handle their signs quite than coping, and ask about how remedy with AUSTEDO® (deutetrabenazine) tablets might assist. Encouraging sufferers to say, ‘It isn’t OK,’ the advert drives consciousness of AUSTEDO, a prescription drugs which will assist handle TD whereas sufferers proceed their psychological well being treatment(s) like antipsychotics or antidepressants.
Tardive dyskinesia is related to sure prescription medicines used to deal with psychological well being or gastrointestinal situations.1,2 One in 4 individuals who take sure psychological well being remedies might develop the uncontrollable actions of TD, together with mild-to-severe twitching, shaking or jerking of palms, toes, face or torso, and extra. Whether or not signs are delicate, average, or extreme, the affect of TD will be vital, inflicting bodily adjustments which will result in useful and emotional adjustments.1,2,3
“As we navigate by means of a world pandemic, we all know there is a rise in people reporting signs of hysteria or depressive dysfunction,” stated Brendan O’Grady, Govt Vice President and Head of North America Business at Teva. “Now greater than ever, you will need to elevate our efforts to help people with TD and psychological well being situations. We developed the ‘It is Not OK – It is TD’ marketing campaign primarily based on priceless insights from sufferers with TD, permitting us to place a a lot wanted and genuine highlight on the dysfunction and the way it can actually affect well-being, whereas driving schooling about AUSTEDO as a remedy which will assist handle their TD signs.”
Individuals residing with psychological well being situations typically really feel stigmatized and delay searching for remedy.4 For some sufferers, discovering the appropriate mixture of psychological well being medicines can take a number of years, and a few residing with TD would quite address their actions than alter their current remedy routine and danger relapse.5,6,7
“TD is already under-diagnosed and under-treated, and with rising telemedicine visits, it is more difficult to visually determine TD actions, leaving sufferers to proceed dealing with the bodily and emotional affect of their signs,” stated Rakesh Jain, MD, MPH, Scientific Professor, Division of Psychiatry, Texas Tech Well being Sciences Middle Faculty of Medication, Midland. “For sufferers with psychological well being situations, it’s important that we provoke open discussions about their expertise with TD and in managing it, we do not take away from their progress and associated remedy plan. I am happy AUSTEDO may help sufferers handle their TD signs with out affecting their psychological well being remedy regimens.”
In a single medical research, AUSTEDO considerably diminished the involuntary actions of TD after 12 weeks of remedy vs. placebo, with enchancment starting to be seen as early as 2 weeks. Moreover, in an open label extension research—the longest TD research thus far—symptom management was sustained by means of 145 weeks, and no new antagonistic occasions have been noticed in comparison with these in pivotal trials. The commonest unintended effects of AUSTEDO embody irritation of the nostril and throat (nasopharyngitis) and issues sleeping (insomnia).8,9,10
A number of informational sources can be found on AUSTEDO.com to assist people all through all the course of—from studying extra about TD to beginning and staying on the right track with remedy:
Moreover, Teva’s Shared Solutions® program is dedicated to partnering with sufferers all through their remedy with AUSTEDO. This consists of monetary help packages the place a devoted workforce of advantages specialists may help eligible sufferers achieve entry to AUSTEDO as quickly as potential by means of:
- AUSTEDO® Copay Program, the place eligible commercially insured sufferers might obtain the remedy for as little as $0 copay monthly
- Help with navigating by means of Medicare Half D
- Further monetary help packages which will exist relying on insurance coverage protection and assembly eligibility necessities
This system’s nurse telephone help additionally permits sufferers to attach with skilled nurses to debate their remedy.
About Tardive Dyskinesia (TD)
Tardive dyskinesia (TD) is related to sure prescription medicines used to deal with psychological well being or gastrointestinal situations.1,2 One in 4 people who find themselves taking sure psychological well being medicines might develop uncontrollable actions of TD. Lengthy-term use of some medicines to deal with schizophrenia, bipolar dysfunction, despair, and another situations can result in TD.2,3
TD can seem as mild-to-severe twitching, shaking or jerking within the palms, toes, face, or torso, involuntary blinking, tongue actions, and different unintentional actions. The severity of TD signs can range from individual to individual, however even delicate signs will be bothersome. The unintentional, uncontrollable actions of TD can affect an individual each bodily and functionally, making actions like strolling, writing, consuming, talking, or swallowing tough.1,2,3
About AUSTEDO® (deutetrabenazine)
AUSTEDO® is a vesicular monoamine transporter 2 (VMAT2) inhibitor accepted by the U.S. Meals and Drug Administration for the remedy of tardive dyskinesia in adults and for the remedy of chorea related to Huntington’s illness. Security and effectiveness in pediatric sufferers haven’t been established.
AUSTEDO® Indications and Utilization
AUSTEDO® is indicated for the remedy of chorea related to Huntington’s illness and for the remedy of tardive dyskinesia in adults.
Essential Security Data About AUSTEDO®
Melancholy and Suicidality in Sufferers with Huntington’s Illness: AUSTEDO® can improve the chance of despair and suicidal ideas and conduct (suicidality) in sufferers with Huntington’s illness. Stability the dangers of despair and suicidality with the medical want for remedy of chorea. Intently monitor sufferers for the emergence or worsening of despair, suicidality, or uncommon adjustments in conduct. Inform sufferers, their caregivers, and households of the chance of despair and suicidality and instruct them to report behaviors of concern promptly to the treating doctor. Train warning when treating sufferers with a historical past of despair or prior suicide makes an attempt or ideation. AUSTEDO® is contraindicated in sufferers who’re suicidal, and in sufferers with untreated or inadequately handled despair.
Contraindications: AUSTEDO® is contraindicated in sufferers with Huntington’s illness who’re suicidal, or have untreated or inadequately handled despair. AUSTEDO® can also be contraindicated in: sufferers with hepatic impairment; sufferers taking reserpine or inside 20 days of discontinuing reserpine; sufferers taking monoamine oxidase inhibitors (MAOIs), or inside 14 days of discontinuing MAOI remedy; and sufferers taking tetrabenazine (Xenazine®) or valbenazine (Ingrezza®).
Scientific Worsening and Hostile Occasions in Sufferers with Huntington’s Illness: AUSTEDO® might trigger a worsening in temper, cognition, rigidity, and useful capability. Prescribers ought to periodically re-evaluate the necessity for AUSTEDO® of their sufferers by assessing the impact on chorea and potential antagonistic results.
QTc Prolongation: AUSTEDO® might delay the QT interval, however the diploma of QT prolongation will not be clinically vital when AUSTEDO® is run throughout the really useful dosage vary. AUSTEDO must be averted in sufferers with congenital lengthy QT syndrome and in sufferers with a historical past of cardiac arrhythmias.
Neuroleptic Malignant Syndrome (NMS), a doubtlessly deadly symptom complicated reported in affiliation with medication that scale back dopaminergic transmission, has been noticed in sufferers receiving tetrabenazine. The chance could also be elevated by concomitant use of dopamine antagonists or antipsychotics. The administration of NMS ought to embody instant discontinuation of AUSTEDO®; intensive symptomatic remedy and medical monitoring; and remedy of any concomitant severe medical issues.
Akathisia, Agitation, and Restlessness: AUSTEDO® might improve the chance of akathisia, agitation, and restlessness. The chance of akathisia could also be elevated by concomitant use of dopamine antagonists or antipsychotics. If a affected person develops akathisia, the AUSTEDO® dose must be diminished; some sufferers might require discontinuation of remedy.
Parkinsonism: AUSTEDO® might trigger parkinsonism in sufferers with Huntington’s illness or tardive dyskinesia. Parkinsonism has additionally been noticed with different VMAT2 inhibitors. The chance of parkinsonism could also be elevated by concomitant use of dopamine antagonists or antipsychotics. If a affected person develops parkinsonism, the AUSTEDO® dose must be diminished; some sufferers might require discontinuation of remedy.
Sedation and Somnolence: Sedation is a typical dose-limiting antagonistic response of AUSTEDO®. Sufferers mustn’t carry out actions requiring psychological alertness, equivalent to working a motorcar or hazardous equipment, till they’re on a upkeep dose of AUSTEDO® and understand how the drug impacts them. Concomitant use of alcohol or different sedating medication might have additive results and worsen sedation and somnolence.
Hyperprolactinemia: Tetrabenazine elevates serum prolactin concentrations in people. If there’s a medical suspicion of symptomatic hyperprolactinemia, acceptable laboratory testing must be achieved and consideration must be given to discontinuation of AUSTEDO®.
Binding to Melanin-Containing Tissues: Deutetrabenazine or its metabolites bind to melanin-containing tissues and will accumulate in these tissues over time. Prescribers ought to pay attention to the potential of long-term ophthalmologic results.
Frequent Hostile Reactions: The commonest antagonistic reactions for AUSTEDO® (>8% and higher than placebo) in a managed medical research in sufferers with Huntington’s illness have been somnolence, diarrhea, dry mouth, and fatigue. The commonest antagonistic reactions for AUSTEDO® (4% and higher than placebo) in managed medical research in sufferers with tardive dyskinesia have been nasopharyngitis and insomnia.
Please see accompanying full Prescribing Information, together with Boxed Warning.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been creating and producing medicines to enhance individuals’s lives for greater than a century. We’re a world chief in generic and specialty medicines with a portfolio consisting of over 3,500 merchandise in almost each therapeutic space. Round 200 million individuals all over the world take a Teva drugs day-after-day, and are served by one of many largest and most complicated provide chains within the pharmaceutical business. Together with our established presence in generics, we have now vital modern analysis and operations supporting our rising portfolio of specialty and biopharmaceutical merchandise. Be taught extra at www.tevapharm.com.
Cautionary Be aware Relating to Ahead-Wanting Statements
This press launch incorporates forward-looking statements throughout the which means of the Personal Securities Litigation Reform Act of 1995 concerning AUSTEDO, that are primarily based on administration’s present beliefs and expectations and are topic to substantial dangers and uncertainties, each recognized and unknown, that would trigger our future outcomes, efficiency or achievements to vary considerably from that expressed or implied by such forward-looking statements. Essential components that would trigger or contribute to such variations embody dangers referring to:
- the business success of AUSTEDO;
- our capacity to efficiently compete within the market, together with: that we’re considerably depending on our generic merchandise; consolidation of our buyer base and business alliances amongst our prospects; delays in launches of latest generic merchandise; the rise within the variety of opponents concentrating on generic alternatives and searching for U.S. market exclusivity for generic variations of great merchandise; our capacity to develop and commercialize biopharmaceutical merchandise; competitors for our specialty merchandise, together with AUSTEDO, AJOVY® and COPAXONE®; our capacity to realize anticipated outcomes from investments in our product pipeline; our capacity to develop and commercialize further pharmaceutical merchandise; and the effectiveness of our patents and different measures to guard our mental property rights;
- our substantial indebtedness, which can restrict our capacity to incur further indebtedness, have interaction in further transactions or make new investments, might end in an additional downgrade of our credit score scores; and our incapacity to boost debt or borrow funds in quantities or on phrases which might be favorable to us;
- our enterprise and operations basically, together with: uncertainty concerning the COVID-19 pandemic and its affect on our enterprise, monetary situation, operations, money flows, and liquidity and on the financial system basically; our capacity to efficiently execute and preserve the actions and efforts associated to the measures we have now taken or might absorb response to the COVID-19 pandemic and related prices therewith; effectiveness of our optimization efforts; our capacity to draw, rent and retain extremely expert personnel; manufacturing or high quality management issues; interruptions in our provide chain; disruptions of data expertise programs; breaches of our information safety; variations in mental property legal guidelines; challenges related to conducting enterprise globally, together with political or financial instability, main hostilities or terrorism; prices and delays ensuing from the intensive pharmaceutical regulation to which we’re topic or delays in governmental processing time as a consequence of journey and work restrictions brought on by the COVID-19 pandemic; the results of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and protection; vital gross sales to a restricted variety of prospects; our capacity to efficiently bid for appropriate acquisition targets or licensing alternatives, or to consummate and combine acquisitions; and our prospects and alternatives for progress if we promote property;
- compliance, regulatory and litigation issues, together with: failure to adjust to complicated authorized and regulatory environments; elevated authorized and regulatory motion in reference to public concern over the abuse of opioid medicines and our capacity to succeed in a ultimate decision of the remaining opioid-related litigation; scrutiny from competitors and pricing authorities all over the world, together with our capacity to efficiently defend towards the U.S. Division of Justice legal expenses of Sherman Act violations; potential legal responsibility for patent infringement; product legal responsibility claims; failure to adjust to complicated Medicare and Medicaid reporting and cost obligations; compliance with anti-corruption sanctions and commerce management legal guidelines; and environmental dangers;
- different monetary and financial dangers, together with: our publicity to foreign money fluctuations and restrictions in addition to credit score dangers; potential impairments of our intangible property; potential vital will increase in tax liabilities (together with because of potential tax reform in the USA); and the impact on our total efficient tax price of the termination or expiration of governmental packages or tax advantages, or of a change in our enterprise;
and different components mentioned on this press launch and in our Quarterly Report on Type 10-Q for the primary quarter of 2021 and in our Annual Report on Type 10-Ok for the 12 months ended December 31, 2020, together with within the sections captioned “Threat Elements” and “Ahead Wanting Statements.” Ahead-looking statements converse solely as of the date on which they’re made, and we assume no obligation to replace or revise any forward-looking statements or different data contained herein, whether or not because of new data, future occasions or in any other case. You’re cautioned to not 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 Medication: Pharmacology, Aspect Results and Abuse Prevention. Hauppauge, NY: Nova Science Publishers, Inc; 2013:235-258.
2 Waln O, Jankovic J. An replace on tardive dyskinesia: from phenomenology to remedy. Tremor Different Hyperkinet Mov. 2013;3:1-11.
3 Nationwide Alliance on Psychological Sickness (NAMI). Tardive Dyskinesia. Accessed April 2021. https://www.nami.org/About-Mental-Illness/Treatments/Mental-Health-Medications/Tardive-Dyskinesia.
4 American Psychiatric Affiliation. Stigma, Prejudice and Discrimination Towards Individuals with Psychological Sickness. APA web site. Accessed April 2021. https://www.psychiatry.org/patients-families/stigma-and-discrimination.
5 Worldwide Bipolar Basis. Discovering the Proper Medicine. 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 obstacles to efficient administration of tardive dyskinesia. Neuropsychiatr Dis Deal with. 2019;15:785-794.
7 Fernandez HH, Stamler D, Davis MD, et al. Lengthy-term security and efficacy of deutetrabenazine for the remedy of tardive dyskinesia. J Neurol Neurosurg Psychiatry. 2019;90(12):1317-1323.
8 AUSTEDO® (deutetrabenazine) tablets present Prescribing Data. Parsippany, NJ. Teva Neuroscience, Inc.
9 Knowledge on file. Parsippany, NJ. Teva Neuroscience, Inc.
10 Anderson KE, Stamler D, Davis MD, et al. Deutetrabenazine for remedy of involuntary actions in sufferers with tardive dyskinesia (AIM-TD): a double-blind, randomised, placebo-controlled, section 3 trial. Lancet Psychiatry. 2017;4(8):595-604.
Kevin C. Mannix
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SOURCE Teva Pharmaceutical Industries Ltd