August 2009: Neurpro Update from UCB
Last week we mentioned that we were checking the status of the
Neupro® rotigotine transdermal patch. Although the patch has been available in Canada and in Europe to Parkinson's disease patients, it is still not available in the US. Originally it was hoped that the patch might return to the US market by the end of 2009 but it now looks as if that will not happen until 2010. At the end of July, UCB submitted extensive information on Neupro® and the cold-chain distribution system to the FDA. UCB is in dialogue with the FDA and is hoping to make Neupro® available to U.S. patients during 2010, subject to FDA approval of the cold-chain distribution system. The importance of the delivery system of the product is to prevent the crystalization issue which caused its removal from the market.
Neupro is currently being introduced in Europe as a treatment for people with moderate to severe restless leg syndrome (RLS).
Many people had wonderful treatment success with the Neupro® patch delivery system only to find their lives turned upside down when it was removed from the market. They and especially PwP families have told their stories at many internet sites. It is not too late to send your stories to UCB as we mentioned in May 2009. The FDA is not without heart but they have a heavy responsibility to the public safety.
To send your story you can use this email address.
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.
We've written about about Neupro® in these articles. There is no question but that it became an effective treatment for many Parkinson's disease patients worldwide.
Addendum April 16, 2012
Look for the patch to be back at your pharmacy in July, 2012. The FDA finally approved the new version of the Neupro Rotigotine Transdermal Patch.
Addendum April 16, 2012
Look for the patch to be back at your pharmacy in July, 2012. The FDA finally approved the new version of the Neupro Rotigotine Transdermal Patch.
Posts
I have heard the argument from the begining and with all due respect, what is the hold up. It is trying to find a central pharmacy that can deleiver it cold to minimize the crystailization?
ReplyDeleteI wish the powers that be would or could move along fasster or should I say as fast as my legs arer loving which is coniserable faster.
If I were to get a prescription from my sleep specialist and fax it overseas as i did before, would it pass customs?
I hope someone out there can definately put them selves in my shoes when I can get them on as I meander around like the living dead, with a wife who grows impatient, a therapaist who can relate as a non military spwes out those famous words,Such, i saw Platoon.
How long do I wait. i have tendered my resignation from my job since I cannot get there on time, cannot focus, appear to be loaded due to some mirapex which no longer works, requiop made is worse and ciniment(sp) no longer works.
log blog.Well, I think for fun I will again try to center myself as I have for the last 16 years and await an educated response
sinerely,
Anonymous(she?he sure wrote a lot of things.
PS. If not for my sense of humor and its various forms, I could really get upset.
Preview-you will get the idea
If Neupro helped you with all of these symptoms, you can help yourself and others by telling your story to UCB by using the email link in the above article.
ReplyDeleteYou will also want to check the link that is being added to the article as an addendum at the bottom. There may still be hope for you obtaining the medicated patch now rather than enduring the long wait until the FDA approval since there does not seem to be a Compassionate Use permitted.
Keep that sense of humor - even without PD it is the vitality which keeps us going - not withstanding that pink energized bunny.
Since there is a problem with Google today, we've been unable to provide the link in this article.
ReplyDeleteSee the 11/26/09 Thanksgiving article for an what might be an open door if you have a prescription key for Neupro.
Scroll to the top or cut and paste this link to the two link article:
http://parkinsonsfocustoday.blogspot.com/2009/11/neupro-availability-update-for-happy-pd.html
I have found that neupro patches are beneficial, however, if I sometimes for whatever reason miss changing the patch I do not sleep AT ALL that night
ReplyDeleteOne reason for not being able to sleep when you don't change the Neupro patch after it has been on for 24 hours is that the patch maintains a a 24 hr delivery and then must be replaced (at another spot on your body) with a new patch,
ReplyDeleteIf you change it before bedtime every day, you will not be receiving any meds if you don't change it before you go to sleep.
While the lack of sleep could be PD symptomatic, it is more likely that it is the because you do not have rotigotine in your system that you remain awake. The patch can also cause sleepiness so if you are not receiving it you stay awake.
Just as you need to titrate down if you are discontinuing its use, not putting on a new patch can cause this probem.
The drowsiness which it can cause is a plus and a minus. While it may help you sleep at night, it is a driving risk during the daytime.
Do you notice any other symptoms if you forget to change the patch after 24 hours?
Is this patch available in South Africa?
ReplyDeleteDear Allan,
ReplyDeleteWe did contact UCB on your behalf. I am sorry to report that the Neupro Rotigotine Transdermal Patch is not currently available in South Africa.
We found this interesting because while we were waiting for the UCB response, we surfed the web and came up with some South African pharmacy lists purporting to have the product.
Nonetheless, USB did request that we forward your information to them, including your doctor's contact info. Locate a 'Contact Us' box in the right column and you can email us so that we can give you the proper UCB contact email and the information list they requested.
I think that the UCB link in the article is for an older UCB email address - we'll check and update that. Meanwhile, send us an email to get the process started.
Best Wishes in your quest
April, 2010 and no new information reagarding eupro. Typical of drug companies and the FDA. Government ineptness. If this works albeit the slight crystalization which prevents 100% of the medication being absorbed so what, there is no safety issues with this, get the drug out there and stop dragging your feet. I am 44yo had symtons since my mid 30's and for the last 10 - 15 yeas no significant therapies to improve quality of life. I wish someone coul d walkinmy shoes and experience the fustration of living with Parkinson's. Time for the government to get things rolling not appoint a task force o conduc a study.
ReplyDeleteSadly I can report that it looks as if the Neupro Rotigotine patch will not be available until the end of 2010.
ReplyDeleteUCB will not be gearing up for production in the US until AFTER the FDA gives their approval.
There will probably be sneak peaks at the early news but don't expect a word from UCB until the patch has rolled off the production line and is at the pharmacies across the country.
There is no question that the process is taking far longer than hoped and probably longer than necessary. But aren't we also the first ones to ask where "they" were when a problem arises?
It is a pity that there can't be a humane/emergency/priority exception made for people who's lives were helped so much and were then cast aside.
It is odd that the European market went through a much shorted process. In the end it will be about 1.5 years faster. While the approval systems are different they go through similar processes. Makes one wonder.
I would like to say that i have really been blessed by God and i still get the patches from the UK and the funds have always been there.I also get Alpha Lipoic Acid treatments from Dr.Berkson at the Integrative Medical Center in Las Cruces,NM.and i am doing great.God Bless
ReplyDeleteDear Kenny A,
ReplyDeleteWhat terrific news that You still can get the patch from the UK. We'd be interested in hearing more - through Contact Us if you would rather not post that information.
In additions we would love to learn about your Alpha Lipoic Acid treatments.
Thank you for posting your comments.
Mags
OMG...My husband has had PD symptoms for about six years but was just diagnosed two years ago. He has a rare form that effects gait and balance - few tremors. Balance so bad he has pretty much been in a wheelchair accept swinging off of rails in home. He is now on Neupro Patch from l to 2 to 3mg in 3 weeks alongside his Levodopa Carbidopa. What a miracle!!! He has been up and able to walk for the first time since June. He actually walked into a dental appointment yesterday. For those of you who have lost hope don't give up. We had all but given up but have regained a new found hope and energy. God bless you all.
ReplyDeleteDear Anonymous
ReplyDeleteYour news is wonderful. I'm sure that everyone is rooting for these positive effects to remain.
There is something to be said for a patch or any form of medication which continues to deliver symptom relief throughout the day in a fairly steady, non-fluctuating rate.
Thank you for your positive note.