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?.
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..
Thats the problem sexy,there is no problem,so they have to conjure one up,start selling,scaring the #$%$ out of weak and long time longs to selling,covering there short position ,they warn us,I knew something was coming,but didn't think it would be this huge,must be a bigger market then I was thinking
That, to me, is the most puzzling aspect of this?!
How did the Suboxone group do in terms of negative urine samples? Did the majority of Suboxone patients go over 50% of the trial with negative urine samples?
They totally disregard the Suboxone comparison, but wasn't it a primary endpoint?