|
Prestwick
Pharmaceuticals Receives FDA Approvable Letter
for XENAZINE(R) (Tetrabenazine) for Treatment of
Chorea Associated with Huntington's Disease
WASHINGTON--(BUSINESS WIRE)--March 31,
2006--Prestwick Pharmaceuticals announced that
the company has received an approvable letter
from the U.S. Food and Drug Administration (FDA)
for XENAZINE(R) (tetrabenazine), which is under
review for the treatment of chorea associated
with Huntington's disease (HD). The approvable
letter specifies conditions that the company
must meet prior to obtaining approval to market
XENAZINE in the U.S. In this letter, the FDA
also indicated its intent to discuss the
company's New Drug Application (NDA) at a public
meeting of the Peripheral and Central Nervous
System Advisory Committee. The date for this
Advisory Committee review has not been set.
"Prestwick is committed to making XENAZINE
available in the U.S. as a treatment option for
patients with chorea associated with
Huntington's disease. We plan to work closely
with the FDA to satisfy the conditions specified
in the approvable letter and to present the
safety and effectiveness of XENAZINE to the
Advisory Committee," said Kathleen
Clarence-Smith, M.D., Ph.D., Chief Executive
Officer of Prestwick Pharmaceuticals.
XENAZINE is a highly selective and reversible
dopamine depletor that works by inhibiting
vesicular monoamine transporter 2 (VMAT2).
XENAZINE is the first product for which an NDA
has been filed in the U.S. for treatment of
chorea associated with Huntington's disease.
Chorea, a debilitating feature of a number of
neurological diseases, is characterized by
excessive, involuntary, and repetitive
movements, which may involve the face, limbs, or
the entire body. In HD, it is the result of
overactivity of the neurotransmitter dopamine.
The FDA designated tetrabenazine an orphan
product for Huntington's disease because it
affects only an estimated 30,000 patients in the
U.S. The FDA also designated tetrabenazine a
fast track product because there are no other
drugs available in the U.S. to treat chorea.
XENAZINE is approved in 8 markets outside of the
U.S. and is currently marketed by Prestwick
Pharmaceuticals Canada as NITOMAN(R).
About Prestwick
Prestwick Pharmaceuticals, Inc. is a
product-based specialty pharmaceutical company
engaged in the development and marketing of
small molecule drugs for chronic diseases of the
central nervous system (CNS). Based in
Washington, DC, the company was formed in
November 2002, and is privately held.
Prestwick Pharmaceuticals has rights to a
portfolio of five product candidates obtained
under licenses from third parties that are being
studied for a range of CNS conditions with
significant unmet needs, including Huntington's
disease, Parkinson's disease, restless legs
syndrome, schizophrenia, autism, Alzheimer's
disease, and sleep apnea. Tetrabenazine, the
company's lead product candidate, was licensed
for marketing in the U.S. and Canada by
Cambridge Laboratories (Ireland), Limited
("Cambridge"), which has worldwide rights to the
product. Cambridge markets the product itself in
the UK and Eire (Ireland), and through marketing
partners in European and other markets.
Contacts:
MCS Public Relations
Ginger Hall, 800-477-9626
gingerh@mcspr.com
|
