Interesting how FDA didnt come down very hard on Probuphine on dosage at meeting, though it was in the FDA pre meeting documents looking more harsh then really was..FDA got their guidance they wanted as they never said dosage was ineffective,only that it might' be ineffective and wanted panel's input and it was very favorable for Probuphine,..
Panel voted drug is effective enough for approval.
Dosing was less of a confusion when Kate Beebee said 12/16 mg is the range, nothing more nothing less..Dr Baxter was at first very confused then understood the doage of Probuphine and did a complete turnaround from surely leaning towards a definite no vote, to a yes vote to approve Probuphine.FDA didnt have a dosing issue so why worry about that,
This is not Big Pharma.Braeburn's 145 million dollar cash investment doesnt grow on Apple Trees.
This was a well thought out ,risk/reward plan and huge investment by Apple Tree Partners/Braeburn
Probuphine is Braeburn's baby-The first drug to market under the Braeburn name.
Everything will be done to attempt to make Probuphine a success.100% effort with Braeburn focused on one drug's potential success,In contrast- If Big Pharma had their hands on Probuphine,no way they could possibly give the same time and effort that Apple Tree/Braeburn will.
And the former top notch Big Pharma executives now head of the Braeburn team,solidifies that the drug is really in excellent hands..
Pimavanserin is not even in PHASE3 trials yet and no guarantee of trial success. They are over 3 years away to market Pimavanserin if next trials will be successful..
Phase3 Trial-Confirmatory Trial- NDA filing- NDA Acceptance-And PDUFA date. Long long ways to go!
Most importantly,Pimavanserin indication will not be same indication Titan is developing their drug for.
Pimavanserin gets no competitive edge.Titan is developing an already approved Parkinson's drug that would be steady and long lasting using same Probuphine technology..
If you want to continue to be a drug addict then continue the daily ritual of everyday drug use including taking Suboxone pill or film.Probuphine implant may allow for better adaption back into Society--
Guesstimates are about 2500-3000 for that 6 mth treatment.
Yes its a voluntary treatment but there is a possibility down the road that the current mandate of doctors able to treat Suboxone patients which currently runs from 30-100 patients,that number could be increased with Probuphine prescriptions.
Imagine doctors not having to tell a patient 'sorry I cant help you, I reached my Suboxone prescription quota go find another location! Instead they might be able to say I can give you something as good as Suboxone, in a Probuphine prescription 6 month implant..
Doesnt this create a new market for Probuphine in the folks that cant receive Suboxone due to restrictions
Also there are many Suboxone patients who are prescribed their monthly prescription but then dont stay in their treatment program so their monthly prescriptions cease.
However with Probuphine, no loss in prescription revenues to Braeburn and Titan due to the one time 6 month prescription of 2500-3000. If a patient doesnt comply with their full treatment program including counseling bottom line to Braeburn/Titan not effected.
Very imporrtant monetary advantage for Company
Nope- an actual delay due to REMS never raised by the FDA at AdCom.
FDA never said there will be a delay or might be a delay, all they said was its cutting it close on a REMS agreement due to PDUFA coming up soon.They never said they didnt think it can get done in time.
Priority review designation might' help to get FDA to expedite on this with Braeburn.
Yes its cutting it close but not out of the question that PDUFA will be on time.
Yes there is a chance for PDUFA delay and as a few here mentioned,,I doubt it would take 3 additional.months to come to an agreement...
IF there is a delay, look out for a PR 1 to 2 weeks before PDUFA.
FDA's concern initially was that the proposed dose MIGHT' not be effective. They NEVER said definitively it wasnt effective-they were just confused on this subject. and needed help. Well they surely got the help they needed to persuade their final decision. ....
They asked the Advisory committee for guidance and majority vote confirms Probuphine's effectiveness is not an issue -and majority vote confirms effectiveness of drug combined with safety profile.warrants FDA approval of Probuphine..Nothing to sugarcoat,nothing to spin.
It was a VERY successful day for Probuphine and will be approved
Looks like the DEA is in agreement on some parts of Braeburn's REMS that FDA was informed about just recently, and not enough time to go over it before Advisory meeting.
Certain parts of the REMS the FDA and Braeburn are already in agreement with so this issue will surely be resolved- and still a possibility can occur within next 4 weeks leading up to PDUFA/
In my opinion,worst case scenario we see a 2-4 week PDUFA delay though FDA has option for up to additional 3 months to decide..
There was no curve on the Suboxone patients taking 12/16 versus the Probuphine patients on the negative urine data -33% Suboxone-and 31% Probuphine/
Safety profile also similar which to me' pretty much indicates Probuphine is similar to 12/16mg Suboxone and should be labeled like that.
Dosing study wouldnt be such a bad idea in future to expand the label.
Back in the days, their preclinical testing convinced them 12/16mg Suboxone = 4-5 Probuphine implants.
REMS of course is an issue but a solveable one. that will surely occur...
Problem is, to make PDUFA,not much time to get REMS in place.
There is a chance for PDUFA delay though im sure IF there is a delay,it would be very short term.
Braeburn will do everything they can to work with FDA to resolve this before PDUFA but its cutting it close!
fill in missing parts -im posting a different way to avoid deletion.,.
No major concern with a patient disappearing- as one doctor even mentioned some cardiac implants are discovered in patients 8-9 yrs later and no issues.
The EVA component in the Probuphine rods according to one of the OB/GYN'S she said ,is very safe, based on her experienrce with contraceptive rods..And if you disappear for years as you say, well tthere is no drug safety issue, as the Buprenorphine in the rods will no longer exist after 6 months..
You are twisting everything and hearing only what you want to hear.Baxter was concerned about reimbursement and dosing at first' because he treats Bupernorphine patients many times on a higher dose above the 12/16mg used as marker at trial. He cautiously wanted to make sure that if approved,Probuphine doesnt somehow set a precedent that his patients would only then be able to get 12 /16 mg dosage of Suboxone. Once he got clarification one has nothing to do with the other, he took Probuphine's side and said Probuphine will be helpful in his practice for some patients..
As far as safety concern,well the overwhelmng majority 12-2 vote speaks for itself as no major concern..
As I said this morning, key is Titan/Braeburn and FDA being on same page for a REMS which wwill definitely be finalized at some point...
0-1 Titan prediction though--I hope we see minimum 2.00 tomorrow..
My Alma Mater Marquette barely' pulled it out for you..ha
My tears finally subsided-Wow!