Updates: Neupro Rotigotine Transdermal Patch
Clinical trials for Transcranial Magnetic Stimulation
We spoke to UCB yesterday about the FDA status of the Neupro(R) Rotigotine (reh tig' ih teen) Transdermal System in the US. UCB is firmly committed to seeing the patch returned to the US market and is actively negotiating with the FDA to determine the next steps.
For those who don't know, Neupro is a patch of the small molecule type (NCE) which delivers rotigotine, a non-ergoline dopamine agonist, on a once daily application. It was approved for treatment of early stage idiopathic Parkinson's disease. The unique aspect of Neupro is that it offers continuous delivery for 24 hours day and night.
Neupro developed a problem of crystallization on the patch which did not interfere with delivery but did require a change in the storage of the product and it was withdrawn from markets worldwide. Patients who had success with the product were distressed. Although Neupro was restored in several European countries, it remains off the US market until the FDA is satisfied.
According to my conversation with Medical Information at UCB, they are very interested in hearing the stories of patients who have used the Neupro Patch. Joanne C in Med Info has indicated that you can share your stories with the company by using the following:
email address at UCB
Please put "Share Neupro - Parkinson's disease stories/experiences with UCB" in the subject line.
The email body should begin: Attn: Joanne C, Medical Information.
Take advantage of this opportunity - they're listening.
If you prefer drop one in the mail box:
UCB, Inc
Medical Information
Attention: Joanne C
1950 Lake Park Drive
Smyrna, Georgia 30080
Here is a link to the original article: http://parkinsonsfocustoday.blogspot.com/2009/04/rotigotine-transdermal-patch-for.html
For those folks looking for information about clinical trials for Transcranial Magnetic Stimulation, here are some additional links to accompany the article posted on 4/07/09
http://clinicaltrials.gov/ct2/results?term=transcranial+magnetic+stimulation+Parkinson%27s+disease&recr=Open&show_flds=Y
http://clinicaltrials.gov/ct2/results?term=transcranial+magnetic+stimulation+Parkinson%27s+disease&show_flds=Y
Thursday, May 7, 2009
14 comments:
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Please help us to understand the patch my dad used it and then they stopped giving it to him and it was really making a difference.
ReplyDeletePlease call if he is able to get it again
Anonymous' comment has been forwarded to UCS Medical Information along with an update request.
ReplyDeleteA new UCB email link has also been posted as I could not get the old one to work.
My husband used Nuepro and found nothing compared to it. I was able to continue getting some via ibenefitRx.com from Germany via the UK.
ReplyDeleteWe still can't understand why it was pulled from the market.
The Neupro patch was withdrawn after crystallization appeared on the patch. Since this was not an "as designed" element - an approved product specification, it was ordered off the market by the FDA and various European agencies.
ReplyDeleteThe product has been gradually reapproved in Europe and Canada and has been back on the market in those areas for many months.
The FDA still appears to needs convincing of the product safety - UCB certainly doesn't want to go through extensive trials again - so negotiations are ongoing.
There is hope floating around that it will be returned by the end of the year but nothing official from the FDA nor the company because there doesn't appear to be news yet.
The FDA has a right to fulfill their responsibility to protect the public and acted out of that responsibility.
We are waiting for another update from UCB. We'll post it at the site as soon as we do.
Been using the patch for 2 years. Getting it in Europe through Isrameds. It is a life saver especially in the off times so they are not so severe. Highly recommended as a complimentary treatment.
ReplyDeleteWe were not fortune enough to get the patch since it was withdrawn. It made a great difference in my husband. We sure will try it again. After not useing it for a long time we are hopeful when it is avaiable it will work again. Hopeful soon.
ReplyDeleteMy husband also used the Patch, and it made 50% or more difference. If we ever get it back I hope it will work as well. We are not able to get it from Europe. The cost and the knowledge of gettiong the patch would be difficult for us.
ReplyDeleteThe happy and sad news is the World Parkinson's Congress discussion of the positive effects of the Neupro (rotigotine) patch
ReplyDeletehttp://www.redorbit.com/news/health/1925183/neupro_rotigotine_provided_clinically_relevant_improvements_in_healthrelated_quality_of/index.html
I understand the Neupro Patch is avaiable through the compassion program or testing program. I am very intrested in getting in either program. The Patch help me and would like to see if it would still help me. I HAVE NOT BEEN ABLE TO GET THE PATCH ANY WAY. THAKS
ReplyDeleteWe have the Neupro patch for the last four days and enough for the next 3 months. Praise the Lord, hope it will work like it did last time.
ReplyDeleteThis is wonderful news!
ReplyDeleteHow did you get the prescription? Through your doctor or the trials?
I got the Neupro Patch again and have had it for the last 6 weeks or more. I am on a trial program. I use mg 24, it is for 3 1/2 months. The other time I was on it they increased the mg much quicker. It did cause some inprovement the first couple of week or maybe a little more. Is 3 1/2 months to long before increase treatment?
ReplyDeleteI am not sure hwo set up the program for 3 1/2 months.
Thank you for sharing this information.
ReplyDeleteWe are assuming that you are in the Named Patient Trial, NCT01095484 which is an observational safty study.
It is important to establish proper titration levels, so yes this format does make sense.
There is another recruiting placebo-controlled study to evaluate the effect of rotigotine on non-motor symptoms of PD. NCT01300819 with increasing levels of rotigotine from 2, 4, 6 and 8mg for a 24 hour period. The sad thing is that it then titrates back down for about 8 days. However, this study appears be recruiting only in Europe where it is already back on the market.
If neither of those is the study for which you are enrolled, we'd like to hear more about your study.
And of course, we'd love to hear more about your experience with symptom relief with the Neupro Rotigotine transdermal patch.
My Husband was Dx with PD in 2000. He is taking the folowing Meds.
ReplyDeleteEntacapone 4 tmes daily Neupro patch 6 mg
Carbidopa SA 4 times daily
Carbidopa Reg. 4 times daily With this Med can
Sertaline 50mg daily he take Buspirone
Namenda 5 mg 2 times daily for aggitation?
Aricept 10 mg at night