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Old 11-23-2015, 09:10 PM
soccertese soccertese is offline
Magnate
 
Join Date: Nov 2007
Posts: 2,531
15 yr Member
soccertese soccertese is offline
Magnate
 
Join Date: Nov 2007
Posts: 2,531
15 yr Member
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Quote:
Originally Posted by Tupelo3 View Post
The trials for both inhalable LD (Acorda cvt-301) and sublingual apomorphine (Cynapsus all-130277) are both moving along according to schedule. That being said, I still don't see them getting approvals and being marketed until sometime in 2018. Acorda is further along in their phases 3 trials, but doesn't anticipate completion until the beginning of 2017. Given the next steps for data analysis, filings and reviews, I would say another year for final approval. Cynapsus is a little further behind. However, they have a faster track approval process from the FDA, so they could possibly be out first. Both should ultimately get approval. Keeping in mind the long delays that Impax had with getting final approval for Rytary due to manufacturing problems (that process also needs FDA approval) Acorda's Civitas division which will do the drug and device production, has a state of the art facility. So, they should have no issues there. I don't know yet what Cynapsus intends to do about manufacturing the strips. Ultimately, adding both of theses rescue drugs to our medication arsenal will be very beneficial to help control serious off episodes.
suffice it to say it just takes too long to get even the most basic pd drug approved. i can see that inhaling anything has inherent risks and needs thorough testing but apomorphine i believe has been around as long as l-dopa so safety isn't an issue. they're running the apomorphine trial near me and they are still looking for volunteers i believe, tough to find pd volunteers. i didn't qualify because i'm still playing around with my meds and couldn't provide a dependable baseline.

as an aside, it's interesting that LCT in N.Z. think they can get their porcine cell implant approved in N.Z. by 2017 or 2018 if they're lucky. might just be hype or maybe i'm incorrect.
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lab rat (11-24-2015), Tupelo3 (11-23-2015)