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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--(BUSINESS WIRE)--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(R) and in Canada as NITOMAN(R) 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.

Contact MCS Public Relations Ginger H. Simms, 800-477-9626 Onsite ICPDMD:
908-531-7690 [log in to unmask]

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