FROM: Medical Letter on the CDC & FDA
DATE: October 3, 2004
SECTION: EXPANDED REPORTING; Pg. 89
HEADLINE: PARKINSON DISEASE;
FDA approves Parcopa orally dissolving tablets for Parkinson disease
SCHWARZ PHARMA, INC., announced that it has received approval from
the U.S.
Food and Drug Administration (FDA) to market Parcopa (carbidopa-levodopa
orally
disintegrating tablets), a unique formulation of carbidopa-levodopa that
dissolves rapidly on the tongue.
Parcopa, which is available in pharmacies, is designed to provide
patients
suffering from Parkinson disease improved access to their medication.
Parkinson's disease patients experience symptoms such as morning
rigidity or
"off periods" - episodes of decreased movement or complete immobility
during the
day - that can make dosing problematic. Unlike conventional
carbidopa-levodopa
tablets, Parcopa dissolves on the tongue using RapiTab technology to
deliver
medicine without the need for water, providing patients with a convenient
means
to take their medication.
"Parkinson's disease presents patients with a host of challenges that
affect
almost every aspect of their daily lives, including their ability to take
medications that are necessary," said Ron Stratton, PhD, president and
COO of
SCHWARZ PHARMA, INC.
"Parcopa was developed to offer a simpler and more convenient way for
patients to access critical levodopa replacement therapy. For instance,
because
Parcopa does not require water, patients can easily take it upon waking
to help
get morning routines moving, resulting in an easier start to the day.
They may
also attain a greater sense of control over daily activities and reduce
concern
about dosing to treat 'off periods' by having Parcopa readily accessible
at all
times," continued Stratton.
Parcopa is available in the same strengths and has the same dosage
schedule
as conventional Sinemet (carbidopa-levodopa) Tablets. The most common
side
effects include involuntary movements and nausea. Each 10 mg/100 mg
tablet and
each 25 mg/100 mg tablet contain phenylalanine 3.4 mg. Each 25 mg/250 mg
tablet
contains phenylalanine 8.4 mg.
SCHWARZ PHARMA's RapiTab Technology formulates medicines into orally
disintegrating tablets that dissolve rapidly on the tongue. They can be
swallowed with or without water and have pleasant tasting flavors such as
citrus
or mint. RapiTab tablets are convenient and easy for patients to
administer,
especially when water is not readily available or patients face certain
obstacles to dosing. SCHWARZ PHARMA's RapiTab Technology is based on the
proprietary DuraSolv technology developed by and licensed from CIMA LABS
INC.
RapiTab Technology has distinct advantages over freeze-dry
technology.
RapiTab Tablets are pleasant tasting, have good mouth feel and are easily
soluble both in water and saliva. It can be used with a wide range of
active
ingredients and strengths. Unlike many other forms of fast-dissolve
tablets,
RapiTab tablets are durable and can be packaged in both blister packs and
conventional bottles.
SCHWARZ PHARMA will use patented RapiTab Technology to develop a
family of
prescription pharmaceutical products for use in primary care,
gastroenterology
and neurology.
SCHWARZ PHARMA, INC., based in Milwaukee, Wisconsin, is a
pharmaceutical
company with proven expertise in the areas of cardiology,
gastroenterology,
urology and neurology.
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