I found this encouraging, and hope some of you will, too. M.Dawn 55/5
Positive Results From Discovery Therapeutics Clinical Trial of Anti-Parkinson
Patch
Wedn
esday, February 11 6:50 PM
RICHMOND, Va. (BW HealthWire) - Discovery Therapeutics Inc. Wednesday reported
that preliminary analyses of a Phase
IIb clinical trial showed significant efficacy and reduced adverse events in
the treatment of patients with mild to severe
Parkinson's disease using a novel transdermal patch.
The once-a-day patch, formulated with Discovery's proprietary dopamine D2
agonist N-0923, reduced daily levodopa in the
three highest dosage groups by more than 30 percent. All patients in the
efficacy evaluable group were able to completely
eliminate use of oral agonists for the full 21-day study, and 27 percent were
able to reduce their levodopa intake to less than the
minimum daily dose (300 mg).
There were no serious or unexpected adverse events, and only two of the 82
patients were discontinued because of adverse
events.
This double-blind, placebo-controlled study was conducted at nine major
Parkinson centers in North America. The study tested
the N-0923 patch in a total of 82 patients in five dosage arms, including one
placebo group, for 21 days. Patients were taken
off their regular dopamine agonists and levodopa therapy the night before
starting treatment with the patch.
Levodopa was then added back, if needed, to maintain control of symptoms. The
primary endpoint was the daily dosage of
levodopa. Other measures of efficacy included the Clinical Global Impression
and Unified Parkinson Disease Rating Scales.
All patients tolerated the immediate transition to the N-0923 patch well,
without the need for a gradual dose escalation typically
required of oral agonists.
The adverse event rate, particularly nausea, was remarkably lower than that
associated with oral agonists. Scores from some of
the efficacy measures suggested that the patch provided superior control of
symptoms relative to the response to the usual oral
therapy.
"These exciting results confirm that our unique molecule and delivery system
represents a significant advance in the treatment
of Parkinson's disease," said Dr. Donald McAfee, president and chief executive
officer of Discovery Therapeutics. "Many
patients, especially those intolerant to oral agonists, showed excellent
responses to the patch therapy."
The company previously announced an agreement with Yoshitomi Pharmaceutical
Industries Ltd. for Japanese development
and marketing. It is currently in negotiations with potential corporate
partners for territories in the rest of the world.
Discovery Therapeutics invents, develops and will commercialize
pharmaceuticals for poorly met medical needs using novel
signal molecule technologies. The company has two technology platforms: one
based on dopamine receptors for the treatment
of movement disorders and the other based on adenosine receptors for the
treatment of cardiovascular indications.
Contact: Discovery Therapeutics Inc., Richmond Donald A. McAfee, 804/358-9468
or EMM Communications Ellen M. Martin, 510/832-2044
