Teva Announces Publication of AIM-TD Study Results in The Lancet Psychiatry for the Investigational Use of Deutetrabenazine in Tardive Dyskinesia

JERUSALEM–()–Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced the publication of results from the Phase III study, AIM-TD (Addressing
Involuntary Movements
in Tardive Dyskinesia),
in the medical journal, The Lancet Psychiatry. The AIM-TD study
evaluated the safety, efficacy and tolerability of the investigational
use of fixed-dose deutetrabenazine (SD-809) compared to placebo for the
treatment of tardive dyskinesia (TD).

“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 Michael Hayden, M.D., Ph.D., President of
Global R&D and Chief Scientific Officer at Teva. “We are pleased to
share this publication with the psychiatry and movement disorder
community, who play a critical role in the identification and treatment
of hyperkinetic movement disorders like TD.”

Deutetrabenazine
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
Principal Investigators Karen E. Anderson, M.D., Associate Professor of
Psychiatry & Neurology at Georgetown MedStar University Hospital, and
Hubert Fernandez, M.D., Professor of Neurology at the Center for
Neurological Restoration at the Cleveland Clinic.

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,…

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