New Data Reported on Tetrabenazine for the Treatment of Pediatric
Hyperkinetic Movement Disorders
Findings Presented at 57th Annual Meeting of the American Academy of
Neurology

Clinical study investigators concluded that tetrabenazine was an
effective and well-tolerated treatment for severe hyperkinetic
movement disorders among children who are resistant to other
medications, according to new data presented today at the 57th
Annual Meeting of the American Academy of Neurology in Miami Beach.

"This is one of the largest reported studies of children treated
with tetrabenazine," said Steven J. Frucht, MD, Assistant Professor
of Neurology, Neurological Institute of New York, Columbia
University Medical, Center for Parkinson's Disease and Other
Movement Disorders, and lead investigator of the study. "We are
encouraged by the fact that nearly three quarters of children
treated with tetrabenazine experienced a reduction in their
involuntary movements."

Study Design and Results

Over the course of 18 years, 30 children aged 18 years and younger
were treated with tetrabenazine at Columbia University Medical
Center for a variety of hyperkinetic movement disorders, including
chorea, dystonia, and Tourette Syndrome or tics. The study was
approved by the medical center's institutional review board, and
neither the study nor the investigators were supported by Prestwick.

A retrospective chart review was conducted to assess the efficacy
and tolerability of tetrabenazine among these patient populations.
Twenty-eight patients (93%) had tried other medications without
adequate relief prior to being placed on tetrabenazine. On average,
patients were treated with a total dose of 150.9 mg/d (4.9 mg/kg/d)
for 1.3 years.

Twenty-two of the 30 patients (73%) experienced a reduction in
movements (as assessed by the examining physician) after starting
tetrabenazine. Sixteen patients continued tetrabenazine along with
at least one other medication to control movements, while movements
were sufficiently controlled with tetrabenazine alone in six
patients. Side effects, which were ameliorated with a reduction in
dose, were experienced in nineteen patients (63%), including
sedation (30%), behavioral changes (20%), depression (10%),
worsening of movements (6%), nausea (3%) and parkinsonism (3%). Nine
patients (30%) discontinued tetrabenazine due to behavior changes
(3), sedation (3), worsening or lack of improvement in movements (2)
and major depression (1).

"The results of this pediatric study support earlier findings in
adults that suggest tetrabenazine may be an effective and well-
tolerated treatment option for severe pediatric hyperkinetic
movement disorders," said Dr. Frucht. "Similarly, side effects were
typically dose-dependent, and we did not observe tardive dyskinesia
in our patient population."

Tetrabenazine

Tetrabenazine is available in some European markets and Australia as
XENAZINE(R) and in Canada as NITOMAN(R) for the treatment of
hyperkinetic movement disorders. Tetrabenazine is not FDA-approved
for marketing in the United States. Side effects can include
drowsiness, insomnia, akathisia and depression.

Prestwick Pharmaceuticals

Prestwick Pharmaceuticals, Inc. is a product-focused specialty
pharmaceutical company engaged in the development and
commercialization of drugs with high commercial potential and
relatively low development risk that target chronic diseases of the
central nervous system. To date, the company has in-licensed rights
relating to product candidates in clinical development for the
treatment of CNS disorders, including chorea associated with
Huntington's Disease, Parkinson's disease and schizophrenia.

In October 2004, Prestwick announced the results of its Phase III
study of tetrabenazine for chorea associated with Huntington's
Disease. The study was conducted in adults only. The company
anticipates filing a New Drug Application (NDA) for tetrabenazine
with the U.S. Food and Drug Administration (FDA) in the near future.
Prestwick was granted both fast track and orphan designation by the
FDA for tetrabenazine.

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Paul Marshall
editor @ tourettes-disorder.com
http://www.tourettes-disorder.com