Two studies
presented late last week at the World Parkinson Congress suggest that the
investigative patch-delivered drug rotigotine, NeuPro, treats the symptoms
of Parkinson's Disease, causes no significant problems during change of
treatment to the drug and is preferred by patients to standard oral therapy.
Rotigotine -- being developed by Schwarz
Pharma -- mimics the action of dopamine and stimulates the part of the
brain that receives dopamine, effectively making the brain "think" it is
receiving dopamine.
Although the investigational patch and existing
oral therapies for Parkinson's are comparable in terms of effectiveness,
the patch solves a major practical dilemma for patients -- being able to
wake up in the morning largely free from the disease's debilitating symptoms,
which can prevent some patients from getting out of bed.
"One of the greatest problems with Parkinson's
patients is that they don't take medications during the night," lead investigator
Nir Giladi, director of movement disorders at Tel Aviv Medical Center and
professor of neurology at Tel Aviv University, told UPI.
"When they wake up in the morning they are
in their 'off' state (when medication has worn off and symptoms reappear)
and are often unable to move or get out of bed," he said.
"This is a very difficult situation for patients
and caregivers, when the patient has to take care of bathroom and other
morning needs. Here we have a patch that was applied a day before, and
patients are much better than usual the next morning," Giladi said. "This
is something we have never seen in drugs that are given orally. It is a
huge advantage afforded by this patch-delivered treatment," he said.
Warren Olanow, professor and chairman of
the department of neurology and professor of neuroscience at the Mount
Sinai School of Medicine, New York, N.Y., agreed.
"Rotigotine transdermal patch administered
once per day has now been demonstrated to reduce the frequency and severity
of Parkinson's Disease symptoms and to have high tolerability. This is
welcome news for patients," he told UPI.
The current gold standard for the treatment
of Parkinson's is levodopa, found in several FDA-approved drugs. However,
the dopamine neurotransmitter that the brain requires for proper motor
(large and small muscle) functioning fluctuates during levodopa treatment.
The result is eventual loss of motor control
and other symptoms most commonly associated with the disease.
The NeuPro patch is designed as an adjunctive
or "add-on" therapy to levodopa. Rotigotine has been approved by the European
Agency for the Evaluation of Medicinal Products and is under review for
approval by the Food and Drug Administration.
Given the potential convenience for patients
and caregivers of a once-daily patch delivery system, the major question
was whether it works as effectively and safely as currently approved add-on
oral therapies.
In one study presented at the conference,
investigators examined the effects of rotigotine on patient "off" time
when added to levodopa in patients with advanced-stage disease.
The researchers randomly assigned 506 subjects
with advanced-stage Parkinson's inadequately controlled with levodopa to
either add-on rotigotine, to a leading add-on oral treatment called pramipexole
-- sold under the brand name Mirapex -- or to placebo.
Rotigotine subjects received a once-daily
patch treatment ranging from 2 mg to 16 mg. Subjects taking pramipexole
received up to 4.5 mg in oral tablets taken three times per day.
The investigators reported an average reduction
in "off" time over a 24-hour period for rotigotine of 2.44 hours, 2.82
hours for pramipexole and 0.88 hours for placebo.
Average increase in time spent without troublesome
motor-related side effects was 2.9 hours for rotigotine, 2.6 hours for
pramipexole and 1.2 hours for placebo.
"This shows us the overall comparable efficacy
of the pill and the patch treatments," Giladi said.
He added that Parkinson's patients are often
on a large number of other medications for concomitant conditions.
"Instead of adding three more pills a day
for Parkinson's symptoms and risking lack of compliance, which can be a
major problem with our patients, you insure with the once-daily patch that
they are getting the anti-Parkinsonian drug into the blood system without
even thinking about it after it is applied.
This addresses a major practical problem
in treating Parkinson's patients," Giladi said.
A second study presented at the Congress
examined the effect of an overnight switch to the rotigotine patch from
three other dopamine-inducing oral treatments. In the study, 116 Parkinson's
subjects were switched overnight to rotigotine from ropinirole -- sold
as Requip -- pramipexole, or cabergoline, sold as Dostinex.
The researchers found that the patch was
equally effective and well-tolerated when compared to the other drugs,
with 90 percent of the patients completing the study.
The researchers also noted that 90 percent
of the subjects preferred the patch to the pills. "It simplifies their
lives," lead investigator James Patton, neurologist at Asheville Neurology
Specialists in Ashville, N.C., told UPI. "And it does so with no loss of
therapeutic efficacy."
Both studies received support from Schwarz
Pharma.
