Adcom is open to public but if someone wanted to speak ,they had to already notify FDA in advance..
Buckle your seats boys, Exciting day tomorrow''
I think there is a good possibility you will be shocked...
Thats the problem with FDA notes.Probuphine worked in the trials but FDA had higher hopes for results.Their unfair expectations is causing this confusion and Titan's presentation tomorrow and along with Advisory committee members hopefully will side with Probuphine and get FDA off their cloud.
FDA wanted to see a grandslam even though Probuphine still hit a homerun out of ballpark.
1-Introduction -Marc Rubin
2-Background & Medical need-Andrea Barthwell MD FASAM Former Deputy Director (ONDCP) Currrent CEO Two Dreams Treatment Center..
3-Clinical Efficacy-Kate Beebe (You go girl!!)
4-Clinical Safety-Steve Chavouste MD Segal Institute Clinical Research.
5-REMS-Gary Neil MD- Braeburn.
6-Back to Kate Beebee for conclusion...
Basically reviewing the NDA for free.
It is good to have different treatment options for opiod abuse..
You want to break the normal routine cycle for these drug addicts..
There is an opiod abuse epidemic and help is needed.,thats not debateable..
Depending on the addicts level of treatment recovery or non recovery, after initially starting with Suboxone,,their doc or shrink would determine if Probuphine would be beneficial to switch over to at some point,or possibly start them on Probuphine......
Alot of patients currently fail treatment not because Suboxone doesnt work,its because they dont take their prescribed daily dose-as addicts are known to be the most non compliant patient type..
Probuphine obviously takes care of the non compliance issues..
What im saying is all moot if Thursday is a disaster.. We all know this can go either way with Advisory committee so let the chips fall where they may''
But its the routine of taking a drug daily which needs to stop.
Part of treatment recovery would be to at least attempt to stop old habits and mentally get used to not relying on putting a drug in your mouth everyday,and thats where Probuphine steps in.
I believe a large subgroup of current Suboxone patients would benefit from Probuphine treatment,not everyone..
Probuphine is not a death sentence,,if it doesnt work for some then they just move on to another treatment..
Wow Now this is very compelling!
FDA kinda minimizing Probuphine positive data results to not look as good as it really was.
Again,we have results just as good if not better than Suboxone during their own approval process.....
This 505B Pathway is all based on Suboxone opening the door for Probuphine-
Probuphine is non inferior to Suboxone based on the studies-The results are being twisted and showing signs of disappointment by FDA because of impossible expectations that couldnt really be reached. by Probuphine or any drug for that matter..
Hopefully FDA will come to their senses which I have surely seen before..
Ok, so FDA had overexpectations for Probuphine.data. This was never going to be a treatment cure..
They need to take a deep breath and compare Probuphine to Suboxone and placebo with their blinders off---
Probuphine is not for everyone but there should be a place for it in the opiod dependence treatment space.The trials were a success, FDA's expectations were not a success and they overreacted to the results.. In my opinion thats the big issue.Advisory committee members need to put some sense and logic back into the minds of the FDA reviewers come Thursday!
Cant figure it out either. Dont know what im missing...
Braeburn/Titan would be wise to have a few successful Probuphine trial patients speak at meeting....
If Probuphine is prescribed as a six month treatment and say within those 6 months low dose of Suboxone is prescribed as rescue medication -so lets say at a maximum cumulative 21-28 days out of the 6, months thats still a huge improvement over taking 12/16mg daily of Subuxone.
This would still help the misuse/abuse and diversion issues of daily prescribed Suboxone while maintaining efficacy. of Probuphine....
Oxycontin FDA approved drug and a contributor to the destruction of many families lives yet Probuphine has to possibly struggle for approval?
ha Makes no sense at all..
No risk with those implants yet approved? hmmmm Surely dont see a safety rejection for Probuphine.
Probuphine vs 12/16 mg daily Suboxone.
Probuphine was shown to be non-inferior to Suboxone in its ability to significantly reduce illicit opiod use over the six month trial.
(proportion negative urine samples) 31% Probuphine 33% Suboxone..
Trial completion same- 64% Probuphine 64% Suboxone
Probuphine and Suboxone also similar safety profile in this study..
No comparitive efficacy huh? B-S....
Cant ask for anything more when you successfully compare your drug to current comparator on market -Suboxone. Did FDA address this study in their notes? You better believe Titan will come Thursday..
So you think addicts who use Suboxone daily are fully abstinent from opiods?
No drug works 100% of time for 100% of patients....Whatever is negatively said about Probuphine still needs to be compared to the drug on market Suboxone.Drug diversion or misuse/abuse of Suboxone is a major problem and Probuphine obviously addresses these issues. Many addicts dont even take their daily Suboxone dosage so you want to talk about efficacy? How effective is Suboxone when an addict is not on drug compared to steady daily dose of Probuphine?
FDA raising possible efficacy issues due to low dose Buprenorphine in Probuphine implants.... HuH?
Did FDA suddenly become blind totthis study and results?
Titan successfully addressed this in the PHASE-3 Confirmatory trial -non inferiority endpoint of Probuphine 6 month implant vs Suboxone 12/16mg daily.
The lower dose Probuphine implant compared to the higher dose Suboxone in this 6 month study showed no statistical difference in efficacy comparing the two drugs.Both drugs showed almost exact same effficacy!
So whats the problem?.