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Old 01-04-2007, 01:20 AM #1
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Default Parkinson's Patch Nears U.S. Approval

Parkinson's Patch Nears U.S. Approval

WebMD
Wednesday, January 03, 2007
By Daniel J. DeNoon
http://www.foxnews.com/story/0,2933,241277,00.html

A once-a-day patch is a safe and effective treatment for early Parkinson's disease, a clinical trial shows.

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 Parkinsonís 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."


By Daniel J. DeNoon, reviewed by Louise Chang, MD

SOURCES: Watts, R.L. Neurology, Jan. 23, 2007; vol 68: pp 272-276. Ray L. Watts, MD, professor and chairman, department of neurology, University of Alabama at Birmingham. Michael Davis, product director, Schwarz Pharma, Milwaukee. Curt R. Freed, MD, head, division of clinical pharmacology and toxicology, University of Colorado Health Science Center, Denver.

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Old 01-04-2007, 01:23 AM #2
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Skin patch eases Parkinson's symptoms, study says

Scientific American
January 03, 2007
By Will Dunham
http://www.sciam.com/print_version.c...807CE4FE8BD0DA

WASHINGTON (Reuters) - A skin patch relieved symptoms of people with early-stage Parkinson's disease, and may offer advantages to taking pills to treat the progressive brain disorder, researchers reported on Wednesday.

The study, involving 277 people in Canada and the United States with early-stage Parkinson's, assessed the Neupro patch, made by Germany's Schwarz Pharma. It delivers a drug called rotigotine that acts like a certain brain chemical that is deficient in people with the disease.

Patients who wore the patch showed a significant easing of their symptoms after six months of treatment, according to the study in the journal Neurology. Those getting a placebo saw their symptoms get worse, the study found.

The study was funded by Schwarz Pharma.

The patch is applied once a day and delivers rotigotine continuously through the skin. Currently, many patients take pills at least three times a day to treat symptoms of the incurable disease.

"I think it's an important new development for Parkinson's patients. For a significant portion of patients, this may offer real advantages," Dr. Ray Watts, chairman of the University of Alabama at Birmingham's Department of Neurology and leader of the study, said in an interview.

Parkinson's affects nerve cells in the area of the brain that controls muscle movement, and is characterized by a shortage of the brain chemical dopamine. Rotigotine imitates the effects of dopamine and helps make up for the shortage.

The disease's main symptoms are trembling in the hands, arms, legs, jaw and face, muscle rigidity, slowness of movement and impaired balance and coordination. The symptoms, which worsen over time, usually develop after age 60.

The study did not directly compare the patch to pills currently used to treat the disease.

The study unique in testing a new delivery system for a dopamine-related drug, Watts said. The patch can provide a steady dose over 24 hours, allowing for a more uniform delivery of medication to the brain than pills might provide, he added.

"Patients who are doing well now on current agents, as long as they're OK taking medication three times a day, there may or may not be an advantage to switching.

"But for newly diagnosed patients, especially younger patients who are going to be treated for a long time, this may be even more important," Watts said.

The patients were recruited into the study from November 2001 through April 2003.

Schwarz Pharma official Michael Davis said the company expects to win approval from the U.S. Food and Drug Administration for the patch to treat early-stage Parkinson's disease in the first half of this year. Davis said the patch is already sold in Germany, Britain and Austria.
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Old 01-04-2007, 03:20 AM #3
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Default I asked my Neuro about this a few months ago ...

and his position was that it could only deliver a lower dose than oral administration and hence was less effective than oral, at least as a mono therapy. Even though it does meet my Neuro's ethos of "a little regularly" removing the peaks and troughs, he felt that more regular oral admin is more effective.

I will be interested to track real life reactions to this patch, however I find it tough to get excited by this.

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Old 01-04-2007, 04:31 AM #4
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Hello again, I posted a couple of times last year...

I'm from the UK, 37 and was diagnosed about a year ago. Main symptoms are a head tremor, tremor and stiffness/slowness in the right hand.

I've been using the patch since July last year in conjunction with Azilect.

I found that initially I had a very positive response - able to wiggle my fingers and the tremor became much less likely to "poke through". But I've found that to maintain the positive effects I've had to titrate up every month or so - past the maximum licensed dose of 8mg to 10mg (with my neurologist's approval). Which has worried me somewhat! We're now discussing a switch to Requip.

Generally I haven't had significant side effects, except I'm slightly more likely to fall asleep on the sofa watching rubbish on TV... Skin reactions have been minimal, except on my belly, where I get unbearable itching within a few hours (the skin is stretched rather thin there though!)

Do other people find that there is a general wearing off or getting accustomed to agonists? Or am I experiencing a placebo effect? Or am I deteriorating as fast as I'm upping the dose?!

So far I've been on 10mg for about a month and am doing OK.

Happy New Year to you all!
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Old 01-04-2007, 10:17 AM #5
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Default Hi Toob ...

good to hear you are on Rasagaline, initially the position of NICE was that it offered no clear benefits over Selegeline, my Neuro mentioned last year that there was a push to get Rasagaline used and it must have been successful.

Which Health Authority do you fall under ?

Your Agonist history doesn't sound very controlled. Personally I have increased my dosage of Mirapex on average every 9 months. I know we are all different but a monthly increase to over the max recommended dose sounds like this is not the best option for you. Reactions to the different agonists varies greatly, (just do a search on this site), so Requip/Mirapex may suit you better, however your experience may support my Neuro's comments that the patch is a "weak" option.

Good luck.

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Old 01-04-2007, 12:14 PM #6
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Thanks for the reply aftermathman. I'm in North Yorkshire.

Interestingly I've had more problems getting the patch via my consultant - the hospital won't supply it - he said it was a policy decision because of lack of evidence of efficacy, so I've had to get it prescribed via my local GP. Which as you might imagine has led to plenty letters going back and forth and a lot of administrative confusion!

There were no problems with prescribing the rasagiline though.

Your comments about needing an increase in dosage every 9 months or so is kind of what I was expecting, so have been a bit spooked by my experience!

All the best.
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Old 01-04-2007, 04:00 PM #7
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Quote:
...19 percent who responded to an inactive placebo patch.
May be it is just all in my head

ba dump dump - pshhh (cymbal crash)
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