Teva to Present AUSTEDO® (deutetrabenazine) Tablets Data at the American Psychiatric Association 2018 Annual Meeting
- [P6.137] Measuring the Health Status Burden of Tardive Dyskinesia (Poster Session 6, May 7, 2018, 2:00-4:00 p.m. ET)
- [P6.138] Predictors of Tardive Dyskinesia in Psychiatric Patients Taking Concomitant Antipsychotics (Poster Session 6, May 7, 2018, 2:00-4:00 p.m. ET)
- [P6.139] Long-Term Improvements in Site-Rated Outcomes with Deutetrabenazine Treatment in Patients with Tardive Dyskinesia (Poster Session 6, May 7, 2018, 2:00-4:00 p.m. ET)
- [P6.140] Long-Term Deutetrabenazine Treatment in Tardive Dyskinesia by Concomitant Dopamine-Receptor Antagonists and Baseline Comorbidities (Poster Session 6, May 7, 2018, 2:00-4:00 p.m. ET)
- [P6.141] Long-Term Treatment with Deutetrabenazine Improves Quality of Life in Patients with Tardive Dyskinesia as Assessed by a Modified Dystonia Scale (Poster Session 6, May 7, 2018, 2:00-4:00 p.m. ET)
- [P8.116] Hospital Utilization Rates Following Antipsychotic Dose Reductions Among Patients with Bipolar and Major Depressive Disorders (Poster Session 8, May 8, 2018, 2:00- 4:00 p.m. ET)
About Tardive Dyskinesia
Tardive dyskinesia (TD) is a disorder that results in involuntary, repetitive body movements.1 This may include grimacing, sticking out the tongue or smacking of the lips.1 Additionally, there may be rapid jerking movements or slow writhing movements.1 In about 20 percent of people, decreased functioning results.2 The condition affects up to 500,000 people in the United States and can be caused by certain medications used to treat mental health conditions or gastrointestinal conditions.3,4
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.
Important Safety Information
AUSTEDO® can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Anyone considering the use of AUSTEDO® must balance the risks of depression and suicidality with the clinical need for treatment of chorea. 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®).
AUSTEDO® may cause a worsening in mood, cognition, rigidity, and functional capacity in patients with Huntington’s disease. Tetrabenazine (a closely related VMAT2 inhibitor) causes an increase in the corrected QT (QTc) interval. A clinically relevant QT prolongation may occur in some patients treated with AUSTEDO® who are CYP2D6 poor metabolizers or are co-administered a strong CYP2D6 inhibitor or other drugs that are known to prolong QTc. Neuroleptic Malignant Syndrome has been observed in patients receiving tetrabenazine. AUSTEDO® may increase the risk of akathisia, agitation, and restlessness. AUSTEDO® may cause parkinsonism in patients with Huntington’s disease. Sedation is a common dose-limiting adverse reaction of AUSTEDO®.
The most common adverse reactions (4% of AUSTEDO®-treated patients and greater than placebo) in controlled clinical studies of patients with tardive dyskinesia were nasopharyngitis and insomnia. The most common adverse reactions (>8% of AUSTEDO®-treated patients and greater than placebo) in a controlled clinical study of patients with chorea associated with Huntington’s disease were somnolence, diarrhea, dry mouth, and fatigue.
Please click here for U.S. Full Prescribing Information, including Boxed Warning: austedo.com/hcp/pi.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions used by millions of patients 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 a world-leading position in innovative treatments for disorders of the central nervous system, including pain, as well as a strong portfolio of respiratory products. Teva integrates its generics and specialty capabilities in its global research and development division to create new ways of addressing unmet patient needs by combining drug development capabilities with devices, services and technologies. Teva's net revenues in 2017 were $22.4 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 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:
- commercial success of AUSTEDO®;
- our specialty medicines business, including: competition for our 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 capabilities; and the effectiveness of our patents and other measures to protect our intellectual property rights;
- our substantially increased indebtedness and significantly decreased cash on hand, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments, and 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: failure to effectively execute the restructuring plan announced in December 2017; uncertainties related to, and failure to achieve, the potential benefits and success of our new senior management team and organizational structure; harm to our pipeline of future products due to the ongoing review of our R&D programs; our ability to develop and commercialize additional pharmaceutical products; potential additional adverse consequences following our resolution with the U.S. government of our FCPA investigation; compliance with sanctions and other trade control laws; manufacturing or quality control problems, which may damage our reputation for quality production and require costly remediation; interruptions in our supply chain; disruptions of our or third party information technology systems or breaches of our data security; the failure to recruit or retain key personnel; variations in intellectual property laws that may adversely affect our ability to manufacture our products; challenges associated with conducting business globally, including adverse effects of political or economic instability, major hostilities or terrorism; significant sales to a limited number of customers in our U.S. market; 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: costs and delays resulting from the extensive governmental regulation to which we are subject; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; governmental investigations into sales and marketing practices; potential liability for patent infringement; product liability claims; increased government scrutiny of our patent settlement agreements; failure to comply with complex Medicare and Medicaid reporting and payment obligations; 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; 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 our Annual Report on Form 10-K for the year ended December 31, 2017, including in the section captioned “Risk Factors,” and in our other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov and www.tevapharm.com. 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.
- "Tardive dyskinesia". rarediseases.info.nih.gov. June 1, 2017. Archived from the original on June 18, 2017. Retrieved June 10, 2017.
- Vijayakumar, D; Jankovic, J (May 2016). "Drug-Induced Dyskinesia, Part 2: Treatment of Tardive Dyskinesia". Drugs. 76 (7): 779–87. doi:10.1007/s40265-016-0568-1. PMID 27091214
- Cloud LJ, Zutshi D, Factor SA. Tardive dyskinesia: therapeutic options for an increasingly common disorder. Neurotherapeutics. 2014;11(1):166-176.
- Tardive Dyskinesia. MHA website. http://www.mentalhealthamerica.net/tardive-dyskinesia. Accessed June 20, 2017.
Teva Pharmaceutical Industries Ltd.
Kevin C. Mannix, 215-591-8912
Ran Meir, 215-591-3033
Tomer Amitai, 972 (3) 926 7656
Doris Saltkill, 816-391-8881
Yonatan Beker, 972 (54) 888 5898
Source: Teva Pharmaceutical Industries Ltd.