Teva to Present AUSTEDO® (deutetrabenazine) Tablets Data at the American Psychiatric Association 2018 Annual Meeting
JERUSALEM--(BUSINESS WIRE)--
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced new scientific abstracts for AUSTEDO® (deutetrabenazine) tablets will be presented at the American Psychiatric Association (APA) 2018 Annual Meeting in New York from May 5-9. The studies shared at the meeting continue to grow the comprehensive body of data supporting the safety and efficacy of AUSTEDO®.
“We are eager to share our research at this prestigious meeting with the psychiatry community who help identify, treat and manage patients with tardive dyskinesia,” said Tushar Shah, M.D., Senior Vice President, Head of Specialty Clinical Development at Teva. “Tardive dyskinesia exacts a considerable burden on patients, and we are excited to share studies providing insights to help these patients.”
The Teva-sponsored data to be presented includes:
[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.
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 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.
JERUSALEM--(BUSINESS WIRE)--
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced new scientific abstracts for AUSTEDO® (deutetrabenazine) tablets will be presented at the American Psychiatric Association (APA) 2018 Annual Meeting in New York from May 5-9. The studies shared at the meeting continue to grow the comprehensive body of data supporting the safety and efficacy of AUSTEDO®.
“We are eager to share our research at this prestigious meeting with the psychiatry community who help identify, treat and manage patients with tardive dyskinesia,” said Tushar Shah, M.D., Senior Vice President, Head of Specialty Clinical Development at Teva. “Tardive dyskinesia exacts a considerable burden on patients, and we are excited to share studies providing insights to help these patients.”
The Teva-sponsored data to be presented includes:
[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.
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 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.
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