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No wonder people with Huntington's Disease are depressed, you'd have to be
insane not to be. That goes for PD too. We're supposed to be jumping for
joy?
----- Original Message -----
From: "John Cottingham"
<[log in to unmask]>
To: <[log in to unmask]>
Sent: Friday, March 11, 2005 3:50 AM
Subject: 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


> The source of this article is PharmaLive: http://tinyurl.com/7xely
>
> 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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