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|June 29, 2017 8:00 a.m.|
|Teva Announces Publication of AIM-TD Study Results in The Lancet Psychiatry for the Investigational Use of Deutetrabenazine in Tardive Dyskinesia|
“TD is a chronic condition that affects patients who are suffering from
primary psychiatric illnesses, which are already debilitating and can be
socially isolating,” said
for treatment of involuntary movements in patients with tardive
dyskinesia (AIM-TD): a double-blind, randomised, placebo-controlled,
phase 3 trial was published online ahead of print in The
Lancet Psychiatry. The AIM-TD study and publication was led by
About the AIM-TD Study
AIM-TD was a Phase III, randomized, double-blind, placebo-controlled, parallel group, fixed-dose study that evaluated 222 male and female adults with moderate to severe TD. All patients had a total motor Abnormal Involuntary Movement Scale (AIMS) ≥ 6 at screening and were randomized at baseline in a 1:1:1:1 ratio to receive one of three fixed-dose regimens of deutetrabenazine (12 mg/day, 24 mg/day, or 36 mg/day) or placebo. Patients underwent dose escalation during the initial 4 weeks, followed by an 8-week maintenance period and a 1-week washout.
About Tardive Dyskinesia
Tardive dyskinesia is a movement disorder characterized by repetitive
and uncontrollable movements of the tongue, lips, face, trunk and
extremities. The often debilitating disorder affects about 500,000
Deutetrabenazine, an investigational treatment for tardive dyskinesia,
is an oral, small molecule inhibitor of vesicular monoamine 2
transporter, or VMAT2, that is designed to regulate the levels of a
specific neurotransmitter, dopamine, in the brain. Deutetrabenazine is
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 deutetrabenazine, 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 20-F for the year ended December 31, 2016 (“Annual Report”), 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.
Teva Pharmaceutical Industries Ltd.