Rytary

#1

I am still waiting for news of the new drug, Rytary, Patrome in the UK? being available here.

I am concerned by this in the patient leaflet....does it mean it can't be taken with Azilect.

"Rytary is contraindicated in patients who are currently taking or have recently (within 2 weeks) taken a nonselective monoamine oxidase (MAO) inhibitor (e.g., phenelzine and tranylcypromine). Hypertension can occur if these drugs are used concurrently."

The availability of an extended release L dopa med will make life so much easier but we feel Azilect has held back progression and is an important part of the symptom control.

Guidance from Research would be helpful.

Thanks

GG

#2

Hi goldengirl

Unfortunately at this time we cannot say how long it will be until this drug will be available in the UK. FDA approval is a big step in the right direction but it is very difficult to predict how long the process may take. We will of course keep an eye out for any developments and share any information as soon as we get it.

We can comment on the contradiction you have quoted. Non selective monoamine oxidase inhibitors, such as phenelzine and tranylcypromine, are old versions of this type of drug. The newer versions are selective and include Azilect (or Rasagiline). This means that it may be possible to take Azilect and Rytary together. However when it comes to prescriptions we recommend getting advice from your Parkinson's specialist.

All the best,

Beckie

The Research Team

 

#3

Hi Research team

Have you got any updates on the availability of Rytary in the UK please. In the UKmi website it shows 'Available only to registered users', not sure what that means. Would this require MHRA approval in addition to the EU approval?

Thanks,

Simon

 

#4

Hi Simon, I am also very keen to know if Rytary will be available in the UK soon!

There are many interesting developments in the pipeline to stop and/reverse Parkinsons but in the short-term it would be wonderful to have a Levadopa drug that stays in the system much longer.

The current  2 hourly doses make life very difficult sometimes.

Any news, Research?

GG

#5

http://www.parkinson.org/Patients/Patients---On-The-Blog/February-2015-(1)/Tips-for-Parkinsons-Disease-Patients-Switching-fr

A summary of the improvements offered.

Not a magic solution but helpful.

GG

#6

Hi Simonw and goldengirl

I'm sorry but we have no new updates, as far as we are aware it is not available to anyone in the UK.

The 'Avaliable only to register users' statement on the UK Medicines Information website means that you have to be a register NHS user and logged into the page to see this additional information. But this doesn't necessarily mean there is additional information that we can't see.

It is possible that Rytary will require other approval in addition to EU approval before it is available to people in the UK - only time will tell.

We appreciate that you are keen to hear about any development of new, potentially more effective, drugs and are keeping an eye on this. We will contact you and let you know as soon as we have any information - we will also keep everyone else updated with news stories on our website.

All the best,

The Research Team

#7

Thanks, Research!

Sorry to keep pestering but it is potentially offering a real improvement to the very limiting meds routine.

GG

#8

Hi GG,

2 hourly doses are indeed a bit painful at times. I have been hoping for a better solution. 

Thanks Research team for the quick update. We shall wait. 

Simon

 

#9

How long should we wait. Please tell as more about this new tablets

Thank you

#10

http://www.pdf.org/en/science_news/release/pr_1420748496

 

Hi Safi

The link will give you the basic facts....it's just a version of Levadopa that will stay in the system longer and mean fewer doses and a more level amount of the drug in the system.

Not a cure but will make life easier!

Lucky Americans....I wonder why we have to wait?

GG

 

#11

Hi Research team,

Any good news on Rytary? Do you have any news on how long do we have to wait

Thanks,
Simon

#12

Hi Simon,

I've passed this on to our Research Team, someone will get back to you soon.

Best wishes,
Alethea
Digital Team
 

#13

Hi all

We are still waiting for more information Rytary and unfortunately cannot give you an estimate of how long you may have to wait.

Whilst Rytary has achieved FDA approval, and is licenced for use in America, it has yet to be EMA approved. The pharmaceutical company have to get EMA approval to licence Rytary use for Parkinson's in Europe, including the UK. We are not involved in this process, it is up to the company that makes the drug to decide where they licence it. But is common for drugs to be licenced by the FDA before the EMA.

Should Rytary be EDA approved, before it would be available the pharmaceutical company would also have to negotiate with UK's National Institute for Health and Care Excellence - or NICE. NICE is a UK government organisation that decides which drugs and treatments are available on the NHS in England and Wales. For more information about this Cancer Research UK have a nice summary: http://www.cancerresearchuk.org/about-cancer/cancers-in-general/cancer-questions/what-is-nice-and-how-does-it-work

In the meantime, we are attempting to contact the pharmaceutical company to find out more about their future plans for Rytary.

Best wishes,

The Research Team

 

#14

Thanks very much for the information, Research team.

Regards,Simon

#15

Wrote a long post and it evaporated when I tried to change a letter to capital.

As always.

So, briefly, thanks research.

We need answers, keep up the pressure.

GG

#16

Hi all

Just to share some responses we have had, firstly from the EMA:

IMPAX labs have submitted an application for a Marketing authorization in EU in June 2014, but up to now the drug you are referring to has not been approved in the EU.

A very similar response was received from IMPAX, the company that makes this drug (although they refer to a later date, possibly something to do with the application being completed/reviewed/amended we cannot be sure):

On November 5, 2014, Impax submitted a Marketing Authorization Application to the European Medicines Agency (EMA). No further information is available at this time.

We were unable to get more information, we do know that the approval process can sometimes take a rather long time. 

As soon as we have an update we will share it.

With very best wishes,

The Research Team

#17

If my dose of Sinemet lasts for 2 hours, how long will a dose of Rytary last?

Peter.

 

#18

I would hope/expect it to be twice as long?

#19

I would too.  However, I want to see that quoted in a document issued by the company who makes it.

Peter.

 

 

#20

I just found the Rytary web site.  They will only admit to a "significant" improvement.  I would like more detail.

Peter.