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|May 02, 2018 8:00 a.m.|
|Teva to Present AUSTEDO® (deutetrabenazine) Tablets Data at the American Psychiatric Association 2018 Annual Meeting|
Three abstracts evaluate the long-term safety and efficacy of AUSTEDO® (deutetrabenazine) tablets for the treatment of tardive dyskinesia in adults
In addition, new health economics data assess quality of life and health burden impact among patients
“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
The Teva-sponsored data to be presented includes:
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
About AUSTEDO® (deutetrabenazine)
AUSTEDO® is a vesicular monoamine transporter 2 (VMAT2)
inhibitor approved by the
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.
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:
and other factors discussed in our Annual Report on Form 10-K for the
Teva Pharmaceutical Industries Ltd.