Numient (like Rytary) authorised in E U


#1



Impax Laboratories have received authorisation in the EU for the use of NUMIENT™ (Levodopa and Carbidopa) Modified-Release Capsules for the treatment of Parkinson's Disease.

Numient is the same as Rytary, which is already available in the U.S.. Rytary and Numient are novel and distinct by including immediate release AND extended release versions of L-dopa. The different versions of Sinemet and Madopar include only immediate release OR extended release versions of L-dopa. For more information go to : Medscape

The authorisation is based on the results of Phase 3 clinical trials, which assessed the safety and efficacy in early and advanced Parkinson's Disease. In the primary clinical trial, advanced Parkinson's Disease treatment with IPX066 (NUMIENT) reduced the "off" time, from 36% to 23% compared to 36% to 29% for immediate-release levodopa-carbidopa. IPX066 (NUMIENT) also increased the "on" time without dyskinesias during waking hours by 1.9 hours compared with an increase of 0.8 hours following treatment with immediate-release levodopa-carbidopa.


#2

hi supa

               golden girl will be interested in this news ,


#3

Thanks Supa and Gus.

It was granted a license a while ago in the EU but the problem is NICE.

It hasn't approved it for use presumably on grounds of expense.

I am not sure how we put pressure on them to look at it as the probability is that 3 doses would work as effectively as 8 of Sinemet.

Any advice, PDUK?

Love

GG


#4

Does anybody know what the daily cost is of, say, 8 Madopars against 3 Numients?

If NICE was really "nice" it would put a value on quality of life for PWPs and I'm sure the sums would then balance out in favour of fewer doses of meds per day. Not to mention time cost savings in fewer prescriptions for docs & pharmacies to issue, and less packaging etc etc..

PUK certainly need to put pressure on NiCE to authorise its use!

S


#5

I agree completely, Supa.

I did say it was licensed some time ago....I checked and it was Nov 15 so only a couple of weeks ago...my mistake.

I think the fear is that it will have a 10 year patent which will make it much more expensive that other drugs.

But most PWP are elderly and have contributed to the cost over a lifetime of working and paying taxes.

Why can we always afford bombs to kill but not drugs to enhance life?

Love

GG

 


#6

 

Hi

lookin at prices online, that isn't nhs prices.

Madopar Roche branded  per pill @ 62.5 ~ 9p  125  was 13p  250 mg was 17p

Couldn't find uk prices for numient/rytary.

looking briefly in a discussion forum around $2 dollars(or exchange rate dollars to £'s  £1.33) was mentioned per pill.


#7

Of course it is going to be expensive, but more than Duodopa?

In 2001 I and many others were put on Mirapexin and Ropinerole, not cheap either in those days. Moreover it would not be for everyone, but , like Duodopa and DBS, for a selective group and very likely they could scale down the present amount of drugs these patients take at the moment, thereby lowering the cost a bit. I am sure they will weigh the pros and cons and I hope there are some on the panel , who decide the outcome, that are  persuasive and make a good case for approval, even if it is restricted to a small group. Maybe PUK can lobby for us.........