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NITOMAN -Tetrabenazine   Message List  
Reply | Forward Message #66 of 94 |

Note * 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 Pharmaceuticals Launches NITOMAN -Tetrabenazine- Patient
Support Program in Canada; Drug Reimbursement and Pharmacist Support
Services Provided for Eligible Patients

DUNDAS, Ontario--(BUSINESS WIRE)--March 18, 2005--Prestwick
Pharmaceuticals Inc., a CNS specialty pharmaceutical company,
announced today the planned launch of the NITOMAN(R) Access Hotline
in Canada, a free telephone support service established to help
patients suffering from hyperkinetic movement disorders to explore
reimbursement options and obtain disease and treatment support in
relation to NITOMAN therapy.


NITOMAN, a dopamine depletor that works by selectively blocking
vesicular monoamine transporter 2 (VMAT2), is the only product
approved in Canada for the treatment of a series of hyperkinetic
movement disorders, including chorea associated with Huntington's
Disease, tardive dyskinesia and Tourette's syndrome. Approximately
50,000 Canadians suffer from these disorders, which are
characterized by excessive, involuntary and repetitive movements,
which may involve the face, limbs or the entire body.

Through the program, eligible patients will receive a free supply of
NITOMAN for six weeks. All patients will receive reimbursement
assistance, if required, which will include insurance benefits and
coverage verification, and prior authorization assistance.

Patient support services will include scheduled phone calls from
registered pharmacists to encourage compliance with the prescribed
dosing regimen and to discuss the potential side effects of therapy.
Additionally, to help ensure that patients receive optimal benefit
from treatment, pharmacists will collect information on dosing and
treatment experience for feedback to patients' physicians.

Patients or their physicians who are interested in initiating the
reimbursement assessment process should call the NITOMAN Access
Hotline at 1-888-NITOMAN (1-888-648-6626). NITOMAN therapy will be
provided to qualified Canadian patients who are in the process of
obtaining either public or private coverage, and meet the approved
indication for NITOMAN as well as the coverage criteria from
public/private payors.

Tetrabenazine

In 2004, Prestwick Pharmaceuticals acquired the rights from
Cambridge Laboratories Ltd., UK, to commercialize tetrabenazine in
Canada under the brand name NITOMAN. Tetrabenazine is available in
some European markets and New Zealand as XENAZINE(R). 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. 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.


---------------------------

Source:

-----------------------

Tourette-Updates
Paul Marshall
editor@...








Mon Mar 21, 2005 6:47 pm

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Note * The company anticipates filing a New Drug Application (NDA) for tetrabenazine with the U.S. Food and Drug Administration (FDA) in the near future. ...
Paul Marshall
paul_tourett...
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Mar 21, 2005
6:47 pm
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