Prestwick Pharmaceuticals, Inc.

March 08, 2005 08:00 ET

New Data Reported on Tetrabenazine in Patients with Movement Disorders and a History of Depression; Findings Presented at 9th International Congress of Parkinson's Disease and Movement Disorders


NEWS RELEASE TRANSMITTED BY CCNMatthews

FOR: PRESTWICK PHARMACEUTICALS, INC.

MARCH 8, 2005 - 08:00 ET

New Data Reported on Tetrabenazine in Patients with
Movement Disorders and a History of Depression;
Findings Presented at 9th International Congress of
Parkinson's Disease and Movement Disorders

NEW ORLEANS--(CCNMatthews - Mar 8, 2005) -

New data show the investigational therapy tetrabenazine may be a safe
and viable treatment option for patients with hyperkinetic movement
disorders who have a prior history of depression, according to research
presented this week at the 9th International Congress of Parkinson's
Disease and Movement Disorders in New Orleans.

"Depression is common among people with Huntington's Disease," said
Joseph Jankovic, M.D., Professor of Neurology and Director, Parkinson's
Disease Center and Movement Disorders Clinic, Baylor College of
Medicine, Houston, and lead study investigator. "These new data show
that a prior history of depression should not preclude patients from
being treated with tetrabenazine."

Previous studies have demonstrated that tetrabenazine, a dopamine
depleter that works by selectively blocking vesicular monoamine
transporter 2 (VMAT2), improves the symptoms associated with a number of
hyperkinetic movement disorders. Clinical study investigators believe
serotonin and nonadrenaline depletion are likely mechanisms of
tetrabenazine-induced depression, which has been reported to occur in
approximately 15 percent of patients treated with the drug.

Study Design and Results

One objective of the retrospective analysis was to provide data on the
potential relationship between pre-existing depression and subsequent
use of tetrabenazine. A total of 518 medical charts were reviewed for
men and women aged 3-87 years treated with tetrabenazine at Baylor
College of Medicine. The indications for treatment included Huntington's
Disease and other choreas (31.3%), tardive dyskinesia (30.1%), dystonia
(27.4%), Tourette syndrome (18.3%) and myoclonus (3.7%).

Responses were assessed using a previously published response scale.
Prior to initiation of tetrabenazine treatment, 272 patients (52.5 %)
had a documented history of depression and/or prior treatment with
antidepressant therapy. Adverse events were captured and coded according
to their relationship to the drug, as well as an existing relationship
to any pre-existing concomitant conditions, such as depression.

Results of the retrospective analysis showed that the percentage of
patients who discontinued treatment was not statistically different in
patients with a prior history of depression (3.3%) and those with no
prior history of depression (2.8%).

The majority of treated patients experienced marked improvement in their
movement disorders. The mean duration of treatment was 29.7 months and
the mean dosage was 62 mg/day. During tetrabenazine treatment, 50
patients (18.4%) had an exacerbation of their depression or required a
change in antidepressant (15.4%) and 28 patients (11.4%) experienced
depression for the first time. A total of 16 patients (3.1%)
discontinued treatment due to an adverse event of depression.

Most adverse events were dose-related, temporary and rapidly reversed.
The most frequent adverse events included drowsiness or fatigue (27.4%),
parkinsonism (11.8%), depression (9.5%), and akathisia (8.9%). No
orthostatic hypotension or new onset tardive dyskinesia was reported. In
this large cohort, the incidence of depression as an adverse event was
lower than in previously published studies.

Hyperkinetic movement disorders, including Huntington's Disease, other
choreas and tardive dyskinesia, are characterized by abnormal
involuntary movements.

Tetrabenazine

Tetrabenazine is available in some European markets and Australia as
XENAZINE® and in Canada as NITOMAN® for the treatment of
hyperkinetic movement disorders. Although currently an investigational
drug in the U.S., tetrabenazine can have a profound effect on chorea,
with many patients demonstrating marked to good improvement. Side
effects can include drowsiness, insomnia, akathisia and depression.

Prestwick Pharmaceuticals

Prestwick Pharmaceuticals, Inc. is an emerging specialty pharmaceutical
company that focuses on treatments for CNS disorders. The company has
multiple product candidates in clinical development for Huntington's
Disease, Parkinson's disease and schizophrenia.

Prestwick recently announced positive Phase III results of the
investigational drug tetrabenazine for chorea associated with
Huntington's Disease. 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 as a therapy
for chorea associated with Huntington's Disease.

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