SOURCE: Hospital Business Week via IncRx.com via NewsRx.com and
NewsRx.net
October 31, 2004
Pg. 8
HEADLINE: SCHWARZ PHARMA, INC.;
Pharma company announces orally dissolving tablets for Parkinson Disease
SCHWARZ PHARMA, INC., announced the launch of Parcopa
(carbidopa-levodopa
orally disintegrating tablets), a unique formulation of
carbidopa-levodopa that
dissolves rapidly on the tongue.
Parcopa, which received approval from the U.S. Food and Drug
Administration
(FDA) on August 27, 2004, is used to treat symptoms of Parkinson disease,
including tremors, stiffness and slowness of movement.
"Parcopa combines an effective treatment for Parkinson disease with
orally
dissolving technology, making it easier and more convenient for patients
to
follow the prescribed dosing schedule," said William Koller, MD, PhD,
Director
of Movement Disorders, Department of Neurology, University of North
Carolina at
Chapel Hill.
Unlike conventional carbidopa-levodopa tablets, Parcopa uses patented
RapiTab technology, an advancement in orally dissolving tablet
technology, to
deliver an oral dose of medication in a convenient, easy-to-use
formulation that
does not require water. Accessibility to medication is an important
advantage
for Parkinson disease patients, who often experience mobility problems
such as
morning rigidity which can make taking their medicine difficult.
"By eliminating the need to obtain water, Parcopa provides Parkinson
disease
patients with easy access to their medication, which may make performing
daily
activities easier," said Ron Stratton, PhD, president and COO of SCHWARZ
PHARMA,
INC. "Parcopa's orally dissolving formulation also offers patients the
ability
to take the medication discreetly in public."
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.
Parkinson disease is a chronic, progressive neurological disorder,
affecting
at least 1.5 million people in the United States, that results from
degeneration
of nerve cells (neurons) in the part of the brain that controls muscle
movement.
This degeneration creates a shortage of the brain signaling chemical
(neurotransmitter) called dopamine, causing movement impairment. Primary
symptoms include tremor of the hands, arms, legs, jaw and face; rigidity
or
stiffness of the limbs and trunk; bradykinesia or slowness of movement;
and
postural instability or impaired balance and coordination.
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 is highly committed to the treatment of neurological
disorders and has a robust pipeline including rotigotine CDS, a new
dopamine
agonist for transdermal treatment of Parkinson disease. The company
recently
reported successful completion of phase III trials and plans to file for
regulatory approval in Q3 2004. The company is also investigating the use
of
rotigotine CDS for treatment of restless legs syndrome (RLS), an
unpleasant
hyperkinesia of the legs that occurs primarily at night.
Harkoseride, a novel agent being investigated for both the treatment
of
epilepsy and neuropathic pain, is currently in Phase III trials.
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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