Sinemet Patch

Sinemet Patch


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Anonymous
Posted: Mon Apr 23, 2007 9:08 pm Post subject: Sinemet Patch

Hello, Can you enlighten us on how the trials are coming along on the Sinemet Patch? How many trials do drugs have to go through before approval? How long is the usual time for something like this to get to the market?
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Dr. FernandezJoined: 20 Jan 2007Posts: 90
Posted: Mon Apr 23, 2007 10:11 pm Post subject:

Hi, I am not aware that sinemet is being developed as a patch. We have tested a dopamine agonist (rotigotine) in the patch form but not sinemet. Typcially, before a drug is approved by the FDA, it should be tested and proven safe among normal individuals (Phase I); tested safe and with some short term efficacy in a small number of PD patients (Phase II); and really safe and with clear efficacy in at least 2 placebo-controlled trials in a large number of PD patients (Phase III). The time depends on a lot of factors...who fast the studies are performed, how clean is the drug, etc. From Phase I to III it can take anywhere from 5 to 10 years. From FDA application to FDA approval, it can take anywhere from 1 to 3 years. Yours, Yours,_________________Hubert H. Fernandez
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