A once-a-day patch is a safe and effective treatment for early
Parkinson's disease - Transdermal rotigotine is the patch's
scientific name. Under the brand name Neupro, it's already sold in
Europe by manufacturer Schwarz Pharma.
Study leader Ray L. Watts, MD, chairman of the neurology department
at the University of Alabama at Birmingham, says that what makes the
patch unique is its continuous, steady delivery of an effective
Parkinson's drug.

"This was the pivotal clinical trial [of the patch] in North America
for early Parkinson's disease," Watts tells WebMD. "It showed that
this treatment provided a very good benefit for Parkinson's disease
symptoms."

Watts and colleagues report the results of the initial six-month
study of the Parkinson's patch in the Jan. 23 issue of the journal
Neurology.

The study shows that 48 percent of people with early Parkinson's
disease responded to the drug, vs. 19 percent who responded to an
inactive placebo patch. Overall, patients had significantly improved
scores on a test of motor function.

Transdermal rotigotine is the patch's scientific name. Under the
brand name Neupro, it's already sold in Europe by manufacturer
Schwarz Pharma.

Study leader Ray L. Watts, MD, chairman of the neurology department
at the University of Alabama at Birmingham, says that what makes the
patch unique is its continuous, steady delivery of an effective
Parkinson's drug.

"This was the pivotal clinical trial [of the patch] in North America
for early Parkinson's disease," Watts tells WebMD. "It showed that
this treatment provided a very good benefit for Parkinson's disease
symptoms."

Watts and colleagues report the results of the initial six-month
study of the Parkinson's patch in the Jan. 23 issue of the journal
Neurology.

The study shows that 48 percent of people with early Parkinson's
disease responded to the drug, vs. 19 percent who responded to an
inactive placebo patch. Overall, patients had significantly improved
scores on a test of motor function.

Parkinson's disease is caused by the death of brain cells that make
an important chemical messenger called dopamine.

The drug L-dopa is still the gold standard Parkinson's treatment. It
works by giving the brain a precursor compound that brain cells turn
into dopamine. It works well -- but after about five years, patients
have a wearing-off effect at the end of each dose. This effect
results in an "on/off" phenomenon when patients suddenly experience
erratic, involuntary motions.

Can Parkinson's Patch Outperform Its Peers?

The Parkinson's patch gives patients a kind of drug known as a
dopamine agonist. It directly plugs in to dopamine receptors on
brain cells. This doesn't work quite as well as dopamine itself --
but because these drugs have a longer half-life than L-dopa, they
smooth out the on/off effect. Half-life is the time that it takes
for half of the drug to be broken down by the body.

"There have been several pivotal studies that show if you start
patients on a dopamine agonist, you get less of these motor
complications after five years," Watts says. "The two currently
leading dopamine agonists, Mirapex and Requip, are oral drugs that
are shown to do that."

Unfortunately, patients on these drugs may begin to experience the
on/off effect as well. It's been thought that this happens because
oral medicines can't deliver a steady stream of the drug to the
brain.

The Parkinson's patch is designed to solve this problem. It bypasses
the digestive system and gives a steady supply of the drug to the
brain.

"From a potency standpoint, no, this compound is no more potent than
other agonists," Watts says. "But this delivery system is unique.
Studies in animals show long-acting delivery over short-acting
delivery reduces Parkinson's disease symptoms. This long-acting
delivery system will be very important, but the longer-term studies
have not yet been done."

Parkinson's expert Curt R. Freed, MD, heads the division of clinical
pharmacology and toxicology at the University of Colorado Health
Science Center in Denver. In an email interview, Freed says that
it's by no means sure that the patch will eliminate the "off"
periods seen with L-dopa and oral dopamine agonists.

"The other dopamine agonists have half-lives in the six-hour range,
which is nearly as good as continuous administration," Freed tells
WebMD. "Patients with advanced Parkinson's disease may have only two
clinical states, immobile 'off' and [involuntary movement] 'on.'
Whether rotigotine by patch will change this scenario remains to be
seen."

U.S.Approval Expected

Schwarz Pharma Product Director Michael Davis tells WebMD that the
FDA has given the Parkinson's patch an "approvable letter." Such
letters usually mean that the agency thinks it has enough
information to approve the drug.

Davis says the company hopes to hear good news from the FDA in the
first half of 2007.

So who will use the drug? Freed says that won't be known until
doctors have a chance to see what the drug can do in widespread
clinical use.

Watts says that the patch is very likely to be helpful "for an
important subset of patients."

"As with any new development and any new treatment for Parkinson's
disease, the patch expands the options for patients," Watts
says. "This is an important step in the treatment of Parkinson's
disease. But there are also many other lines of investigation that
will lead to new treatments."

Daniel J. DeNoon
1/3/07(Fox News.com)