Hi, alll
Just wana share the following information I got from the net with u.
Thanx
Farley
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Parkinson's Skin Patch Gives Positive Interim Results in Phase IIb
Trial
RICHMOND, Va.-- Feb. 11, 1997-- Discovery Therapeutics, Inc.
today revealed preliminary results
from a scheduled interim analysis of data from the company's
Phase IIb clinical trial testing its dopamine
agonist transdermal patch for Parkinson's disease.
The N-0923 patch fully replaced existing oral agonist
therapy and reduced daily levodopa dosage in all
four patient treatment groups by an average of 20-30%
compared to baseline; statistically significant
differences were detected in two of the four dosage groups,
despite the small sample size and the placebo
effect typical in such studies.
This double-blind, placebo-controlled study is ongoing at
multiple centers in North America. The study is
designed to test the N-0923 patch in a total of 75 patients
in five dosage arms, including one placebo
group, for 21 days. Patients are taken off their regular
dopamine agonists and levodopa treatments before
starting treatment with the patch. Levodopa is then added
back as needed to maintain control of
symptoms. Primary endpoints include the amount of levodopa
used and Clinical Global Impression (CGI)
scores. The interim analysis was scheduled to cover the
first 14 days of treatment in the first 25 patients (5
patients per treatment group).
All patients tolerated the immediate transition to the
N-0923 patch well, with no need for dose titration.
The patch was fully efficacious throughout the treatment
period. There were no dropouts from the study
and no serious or unexpected adverse events. While the small
sample size in this interim analysis was
insufficient to detect differences in all dose groups and in
CGI scores, statistical power calculations
indicate that meaningful differences should be detectable in
the full 75-patient study.
Discovery Therapeutics, Inc. is an independent company
founded to invent, develop and commercialize
pharmaceuticals for poorly-met medical needs using novel
signal molecule technologies. Discovery
Therapeutics has two technology platforms: one based on
dopamine for the treatment of movement
disorders and the other on adenosine for the treatment and
diagnosis of coronary artery disease and
cardiac dysrhythmias.
=======
WILMINGTON, Del., Aug. 5, 1996 -- The DuPont Merck Pharmaceutical
Company (DuPont Pharma)
announced today that Carbex(TM) (selegiline HCl) Tablets,
USP, have been cleared for marketing by the
Food and Drug Administration as adjunctive therapy for
managing Parkinson's disease symptoms.
CARBEX, which is available in tablet rather than capsule
form is bioequivalent, and therefore,
therapeutically equivalent to Eldepryl(R) (selegiline
hydrochloride) tablets as indicated in the treatment of
Parkinson's disease.
CARBEX will complement DuPont Pharma's established line of
Parkinson's disease therapies, including
Sinemet(R) CR (Carbidopa-Levodopa) Sustained-Release
Tablets, immediate-release Sinemet(R)
(Carbidopa-Levodopa) Tablets and Symmetrel(R) (amantadine
hydrochloride) capsules. Sinemet(R) CR
and Sinemet(R) are the standard prescriptions for
Parkinson's disease in the U.S.
More than one million Americans suffer from Parkinson's
disease, a progressive neurological disorder that
affects muscle control. The disease is believed to be
caused by a lack of dopamine in the brain.
CARBEX is used as an adjunctive therapy with Sinemet(R) CR
and Sinemet(R) when there is a
deterioration in the quality of response to
levodopa/carbidopa therapy. CARBEX prevents the enzyme
monoamine oxidase type B (MAO B) from breaking down
dopamine in the brain. This
allows dopamine to remain active in the brain for a longer
period of time.
Common side effects of selegiline include nausea,
dizziness, confusion, hallucinations and dykskinesia
(uncontrolled movements). CARBEX is contraindicated in
patients with hypersensitivity to selegiline
hydrochloride and in patients taking Demerol(R) (meperidine
HCl, USP).
DuPont Merck Pharmaceutical Company is a worldwide,
research-based pharmaceutical company.
Formed in 1991 as a partnership between DuPont (NYSE: DD)
and Merck & Co., Inc. (NYSE: MRK),
DuPont Merck is focused on research, development and
delivery of pharmaceuticals to treat unmet
medical needs and the fight against heart disease, central
nervous system disorders, cancer, HIV and
arthritis-related disorders. The company is also a leader
in
radiopharmaceuticals. DuPont Merck markets its products
under the DuPont Pharma name.
