Rytary


#1

The problem with Levadopa has always been formulating an extended release version that works.

Today the drug, Rytary, has been approved for prescription in America from February.

http://www.nasdaq.com/article/impax-wins-fda-nod-for-rytary-er-capsules-for-treatment-of-parkinsons-disease-20150108-00384

I see 2 drawbacks...I don't know if/when it will be available in the UK and I don't think it can be taken alongside Azilect.

But it is a step in the right direction for those who have to take meds every 2 hours to avoid off periods and for whom Sinemet CR doesn't work.

Onward and upward!

Less despairingly

GG

 


#2

GG,

I found this information:     the EU applied for licence  in November 2014. The drug is called Patrome in the EU (Rytary is the US name). Not known when it will be available here.


#3

Thank you, Kate

I will keep an eye out for news of release in the UK.

Until a cure is found or at least a drug to stop progression, the improved ways of delivering Levadopa are the best thing we can hope for.An extended release mechanism would improve life enormously.

GG


#4

GG,

You can read information on the FDA site, but as I understand this, Azilect (Rasagiline) and  Selegiline can be taken with it.

I see it as the only solution that might help people who would otherwise (if the cost was no consideration) have  benefited from getting duodopa.

The FDA approval took from April 2014 to Jan 2015, maybe that gives an indication of the time needed for the EU approval. (Nov 2014 to Aug 2015??) Some time in autumn?


#5

Thanks, Kate for the encouraging info.

I wonder if Research would like to comment?

I am still confused about the not with MAO inhibitors qualification....

if indeed it is to be available this year It is very good news.

GG


#6

GG,

It mentions that nonselective MAO inhibitors cannot be taken with it. Rasagiline and Selegiline are apparently selective inhibitors. The nonselective form combined with Rytary would give you high blood pressure. 


#7

Any recent news on Rytary or Patrome please? is it available yet in this country? it sounds amazing and i will mention it to my Neurologist on my next visit. 

Cheers Dolly


#8

I have not found any recent news on Patrome/Rytary/Numient. Apparently it will go under that last name in Europe. There is an intriguing page on a NHS websiite. I intend to ask my neurology nurse if she can  get further into this, as that will only be accessible for "registered users".. Have a look at www.ukmi.nhs.uk/applications/ndo/record_view_open.asp?newDrugID=5396

You will see that "UK launch plans" has been left open....


#9

Surely PDUK can access the site and post an update?

We are holding our breath...

GG


#10

Hello

Thank you for your queries in to the treatment Rytary (US)/ Patrome (EU). We did contact the European Medicines Agency (EMA) late last year to determine the situation regarding this treatment.

The EMA informed us that they had completed an evaluation of this levodopa/ carbidopa treatment developed by IMPAX laboratories, and recommended that it be authorised for use in the European Union. The EMA recommendation will now be forwarded on to the European Commission, the body with the authority to grant marketing authorisation of medicines in the EU.

However, it is important to note that once a medicine has received a marketing authorisation in the EU, it is up to the company (IMPAX) to decide when and in which countries in the EU they will market the medicine.

We will make sure to update you on any further information we receive about this treatment.

I hope this helps.

Best wishes,

Rachel


#11

Rachel , if you look under Numient (the name they apparently will be using in the EU) on the EMA website , you will find it is authorised.I understood from the information that the next step is up to the individual countries that want to make it available .Here in the UK I expect NICE first to scrutinise its cost versus effectiveness in  controlling PD symptoms.. I am sure Impax will be straining at the leash to introduce (Sell) it in every European country after all the delays they have had to get it approved? Regards, Kate


#12

Hello Kate

Thank you for your post and flagging the EU name Numient.

Now that it has been authorised it will be up to the company (IMPAX) to decide which countries in the EU they want to market the treatment in. They will then have to work with the relevant agencies in each country (in our case NICE) to negotiate costs and determine if the treatment can be available on the NHS.

Best wishes,

Rachel


#13

Thanks for the clarification, Kate and Rachel.

It seems we are no further forward.

Still waiting for NICE approval.

If it's a matter of cost, much dearer than Sinemet etc, we can expect a long wait as we have a lot of bombs to pay for and £5 million to find from taxpayers money promised to selected firms to pay for new energy-saving lightbulbs!

GG