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But the point that I am making is that a drug that is already approved by the FDA with the exact same formulation, agonist antagonist, that uses beads of opioid and naltrexone.
So what I'm saying is how can the FDA use verbiage for Embeda, whether it is an ER drug or not, that says sprinkle with applesauce. Yet not allow Elite do the same for their IR drug?
Doesn't make sense does it.
But I agree with Dr Ryan. A BE study wouldn't be very large in number of patients and also very difficult in performing let's say over a week. Then as long protocol of blood draws are followed to get the concentration levels and affects of opioids, the data should not be very hard to compile and package for presentation.
Just my two cents.
Embeda is already approved and the instructions can be found not only in the message board but anywhere that is searchable for Embeda.
Except we have already found and have stated that Embeda, Pfizer's ER formulation which I deed has the same technology, has in their labeling/instructions the EXACT same wording of sprinkling on applesauce.
Soooooo. What say you now?
IN MY OPINION TO ANSWER YOUR QUESTION
LABELING REVISIONS EARLIEST OCTOBER TO DECEMBER
STUDY FOR FATTY MEAL SPRINKLING ON FOOD EARLIEST December to February
But as you may have seen from my earlier posts that Eugene Pfeiffer was brought in with the knowledge and experience of handling FDA drug legalities as his forte. So I personally think that Eugene is about earn his keep and bring a labeling revision that the FDA will accept and will approve by years end.
Lol. Namtae even though we don't see eye to eye I enjoy your presense. Keeps me on my toes and keeps me searching and not just settle on status quo. Thank you
MRW....I love your gusto and enthusiasm but every time a question YOU ask will never get answered. But the questions abound for YOU to answer. It's almost pointless.
But thanks for your never ending information and positivity.
MRW....I love your gusto and enthusiasm but every time a question YOU ask will never get answered. But the questions abound for YOU to answer. It's almost pointless.
But thanks for your never ending information and positivity.
That's like saying to an anaphylaxis patient what happens if you are on a plane and have a peanut allergy.
PERSONAL RESPONSIBILITY AND PLAN ACCORDINGLY
just my thoughts but of course I am PROelite
Honestly I think is where Eugene Pfeiffer comes into the picture.
He was brought in to possibly be the plan B if SequestOx had "issues" from the FDA.
Your thoughts?
Dr Spec.....one thing I would like to point out and maybe ask is how can Embeda be approved as an ADF or ADT formulation if it specifically says in their labeling the following:
"Misuse and abuse of Embeda by tampering with the formulation, crushing or chewing the pellets, CAUSES RAPID RELEASE AND ABSORPTION OF BOTH MORPHINE AND NALTREXONE."
So if Embeda uses the same technology as Elite of agonist antagonist with naltrexone the affect of such "crushing or chewing" would negate the opioid from reaching the receptor. How can they say you may overdose if crushed or chewed if the naltrexone is the anti abuse deterrent.
Their labeling seems to be in line with how the labeling should be for elite. Yet for Elite it is a "safety concern" but for Embeda it's approved with such "labelling" to satisfy the FDA.
Hmmmmmmmm
Uhhhhh. I was literally just wanting to know what the FDA classifies a fatty meal.
Jumping to the conclusion that people in pain are unable to "know their name" is a bit much.
I mean are we talking 2 double cheeseburgers fries and an apple pie topped off with a 44oz coke?
Or a 12ox steak with loaded mashed potatoes dripping with butter bacon and cheese with like cheesecake for dessert?
Too many unknowns still as of yet to say one way or another.
It just seems as though FDA is being awfully picky and finicky about what they want. They want their cake and eat it too.
I would just like to know what the hell they mean by a "fatty meal"???
So you are telling me that there is an actual IR opioid that says something about the TMAX being extended to feel effect due to food?
I'll be. Thanks for sharing the "labeling"
I agree.
The patient needs to simply understand that IF they start to feel pain and for whatever reason JUST ate a "fatty meal" they need to take it with the foreknowledge of the slowed effects and not to take another one. Because correct me if I'm wrong;
It's not a matter of if the drug still works or peak levels are reached it is just delayed to feel the levels of relief.
Correct?
Meaning? Good or bad? Or a matter of semantics?
Yes indeed. Thanks.
Assuming the FDA knew it was issuing a CRL?
I personally can't wrap my brain around that. If there were any issues that were needing to be addressed an adcom would have been scheduled.
I too believe the author doesn't have a true representation of the facts and presents them in a way that would seem couldn't be overcome.
Opinion based piece in my opinion.
Then my question to you and anyone else who says or thinks Nasrat just "willingly" decides to disregard this;
Why would FDA grant priority review? Why would there be NO ADCOM?
Those two things aren't just given to anybody.
Hmmmmmmm
Awesome. Thanks for not sugar coating your response. Sorry I was wrong in the sense that you prescribe it in that way. Traditionally wouldn't IR be prescribed for acute or short term pain and like wise ER be prescribed for chronic long term pain?
Very sorry to challenge you.
"EVERY" clinical study?
Please provide facts backing your statement.
Then we can discuss.
But until then you want us all to believe what you say based upon what you "say" to be truth.
The P3 was following a bunionectomy in which even Nasrat stated was followed post op and fed while under care then released and went home. What adverse event are there to be?
Please do explain why that would be "bullshit" as you say?
Zero adverse events would mean death or side effects that would be deemed negatively. In a controlled environment and proper dosing and monitoring why would there be adverse events if the technology and delivery was correct and worked in?
Thoughts?
I agree. But again this is where personal responsibility and risk/reward benefit should be solely on the patient taking the pill and the doctor who prescribed it to "instruct" the patient on how to take it "safely". Or the doctor should ask questions on a patients diet in order to ascertain the possibility of fatty diets to properly prescribe the correct dosage. Because dosing has an affect on TMAX does it not?
But in the sue happy world everyone is at risk and the FDA pulled the "safety" card instead of "labeling" card.
Thoughts
Ok I understand that. So my question is this?
What would a new study show? If a person can not follow directions and take the medicine as prescribed; a new study will only show the same results.
UNLESS.....they specifically use namtae's example of "let's say a person eats a fatty meal. 30 minutes later starts to have pain. What should/would the patient need to do to relieve such pain."
So namtae here is my answer (even though I'm still waiting for my answer from you)
Wait 1 and a half more hours to properly take the pill and get full effect ( not likely because if a person is indeed in pain and needs to take a pill; more than likely won't want to wait. I know I wouldn't want to be in pain. And wait 1.5 hours)
OR
After eating the fatty meal and new onset of acute pain 30 mins later decide to "sprinkle" the SequestOx onto applesauce and eat it, which would still give full effect relief.
ALL ASSUMING that is the solution. If fda wants a new study to test that then there are no ifs ands or buts.
So we wait and see.
But wasn't it bioequivalent? But because it wasn't "sprinkled" on a fatty meal that's why we are here. Correct or am I reading it wrong?
Likewise. I always try to answer your questions but you won't answer mine and yet try and tell me I should answer yours?
Answer mine please
That's the point I'm making. IR oxy is for acute pain. Not chronic.
Someone who is prescribed IR opioids is for acute pain whether it is short term relief after adverse event such as injury or after a surgery.
A person. On a IR oxy will not be taking it for an extended amount of time. In my opinion this is a safety concern but easily fixed with a labeling revision.
All just MY OPINION.
thoughts from anyone willing to discuss and have a dialogue please respond.
Not sure what you are asking me. Oxy is addictive regardless or meal intake or pain intolerance.
So meals have nothing to do with oxy being addictive or any opioid for that matter.
Very good question. Let me answer your question with a question.
What is the sole and primary purpose for issuing a prescription of "IMMEDIATE RELEASE" oxy?
You know sometimes I don't know what I'm saying. My brain goes faster than my fingers typing sometimes. So by the time my fingers catch up to my brain my brain has already moved on or has stopped thinking for the moment.
[quoteWouldnt the FDA suggest ELTP to modify their labeling to provide for fatty foods if that was their concern? ][/quote]
Yes I do think that. But that is the point of the CRL isn't it? While the CRL is the new format and not "rejection" letters anymore. Let's start off and remove the CRL for a moment because as of july 15th moving forward it's a mute point until we know what the fda says futher.
So let's start with the new gullies as of March 22nd 2016. By this particular date elite has both submitted an application based upon "old guidelines" and Dr hertz's guidance. Correct? If in fact Dr Hertz never said a fatty foods trial or even a concern before then, what changed in the new guidelines that specifically says so? There isn't any specificity to such concerns in the new guidelines. So how could or would elite know that THIS would have been a concern? ALL ASSUMING HERE.
However I will say that if the FDA says if someone eats a fatty meal but then 30 minutes later has pain and takes a pill they won't receive the same effect as if they "followed the damn directions" in the first place the patient may "overdose" due to taking one or two or three more until they "feel relief".
Yes I agree that IS a safety concern because of obvious reasons key word "overdose". But if elite didn't think that perhaps wording in the packaging insert should need to say "if you plan on eating a fatty meal" blah blah blah. Then the fda says "hold on".
Because Nasrat DOES admit in the CC they "knew" about a TMAX delay. But if guidelines and guidance from Dr Hertz changed AFTER submittal or acceptance of the application what is Elite to do?
This is all assuming though. I don't know and no one else knows.
I guess my point is I believe "safety concern" can be easily paralleled to a "labeling concern".
Why you should?
If the data is already shown to have a delay in TMAX if a fatty meal is eaten. Why would another study or trial be needed to show the exact same thing? Unless the FDA specifically wants a study of X# patients who "sprinkle" sequestox on the the apple sauce just before eating said fatty meal. Then in that case yes fda wants and fda gets. But labeling could easily address this by saying that if eating a fatty meal there could be a delay in relief.
So while "safety" concern sounds more serious than "labeling" I agree but then again they a parallel in this context. Interchangeable because a simple "labeling" revision to address said "safety" concern.
I hope I made sense. My brain is all over the place and my fingers can't go fast enough.
Thoughts?
Of course you can presume assume or anything else.
But my point is this. If elite submitted the application before January and the fda "accepted/received/acknowledged" the application in January. Then on March 19th (I believe) approved the application for priority review then a few days later come out with guidelines that SAYS NOTHING about fatty foods and what ifs how would elite "know" that they would feel this way when FDA new guidelines do not say verbatim "if you submit an application keep in mind to do a fatty foods test"
How would elite know to do this? Or why would they think people not following the friggin instructions on the label or packaging insert that now all of a sudden would be a problem?
So what you are saying is if a label does not specify about fatty foods and affecting the relief rate that "COULD" cause a patient to take more than "DIRECTED" it would not be a safety issue????
Please do tell me how they are interchangeable "IF" indeed that "IS" the concern?
Again I enjoy the dialogue and hope to hear your response
Curious but don't you think that if Elite THOUGHT their BE study, HAL study, and P3 was in anyway deficient to the standard that apparently FDA is now holding companies to despite the fact that current drugs have never been under the same scrutiny that Elite 1) had time to try and fix the problem such as Kempharm did by amending at the last minute and still get a CRL 2) thought that they had sufficient evidence that taking a pill with fatty foods would delay Tmax but thought that with proper instructions and prior guidelines and acceptance by DR Hertz would not need to address this since it is a patient responsibility issue to follow directions, 3) that this is just the FDA wanting better labeling and to address this issue in packaging to cover all bases
Would love to hear an actual response please.
Thanks in advance.
Oh and of course this is just My OPINION.
Actually it isn't.
And they submitted the application prior to March 22nd too. So yes you are correct. The guidelines changed prior to the elite knowing the new changes.
The 2 times I was prescribed opioids was ACL reconstruction which I was pretty doped up postop so I do not know as to how many pills were prescribed. Judging how high I got they must have been pretty strong. But a week's worth was all I was given for postop. Sure ACL and back surgery are two different beasts.
And the other was rotator cuff tear (partial) and was given 20 of 7.5mg. Which lasted me much longer due to it did take it as needed. So really only one else a day after a long day.
So just going off my own experience my doctor who is a orthopedic surgeon he was very cautious about not giving to many and not allowing refill unless I came back in to see him. Which each event I went through I had at least 4 follow up visits. ACL obviously more than rotator cuff.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm491739.htm
So with my previous post I was trying to say that even IF a patient who is having acute pain and perhaps needs 1 week of pills and the doctor prescribing gives adequate amount to get through the event. If for whatever reason even AFTER doctor does their job of telling the patient how to take it, the pharmacist does their job and tells the patient how to take it, if the patient does not follow the directions and eats a fatty meal as described by FDA concern for safety. If the patient takes 2 or 3 because they "didn't feel the effect" but then due to taking more than DIRECTRD by doctor, the patient will run out of pills and need to go back to the doctor who prescribed to get more. It again falls on the doctor to say, " hey we just gave you 20 pills and you are back trying to get more."
Again it falls back on the doctor to ask questions as to why the patient ran out to begin with. Not Elites problem.
So my point is that if by "labeling" that if a patient is to eat a fatty meal here are the steps to take in order to still get immediate relief but also enjoy your fatty meal.
www.cdc.gov/drugoverdose/prescribing/guideline.html
#6 states
"Long-term opioid use often begins with treatment of acute pain.
When opioids are used for acute pain, clinicians should prescribe
the lowest effective dose of immediate-release opioids and should
prescribe no greater quantity than needed for the expected duration
of pain severe enough to require opioids. Three days or less will
often be sufficient; more than seven days will rarely be needed."
Again referring to my own personal saga of injury over the last year I have been prescribed 2 prescriptions of opioids. Same brand each time. The point I am referencing from the CDC is that when prescribed an opioid I was only given 20 pills with NO refill possibilities. When prescribing IR opioids they are used for ACUTE pain. Of which should only be used as an "AS NEEDED" basis and also prescribed the amount that that a doctor feels is necessary for in which to over come the acute pain.
So my question is for any REAL doctors in the house if let's say a person is prescribed 20 pills that IF taken every 4-6 hours OR as needed we are talking about minimum 3 days of pills to a maximum of 5 days of pills. Now there are also varying dosages in which to prescribe from small dosages to large dosages.
The point I am making is that if a doctor who signs his name on the prescription has the ultimate responsibility to prescribe only what is needed to overcome acute paid, since this is an immediate release drug for acute (non long term pain) then the doctor is the one who has to judge who is an abuser and who needs the drug for pain. Likewise with the doctor, as my orthopedic surgeon told me, is that as a doctor prescribing an opioid that he is tracked by big brother with the prescriptions he issues for opioids and quantity of each prescription.
Next the patient is involved in the sense that as many have proclaimed there is a sense of self responsibility to follow directions. So I won't beat a dead horse.
So why is it up to the manufacturer to ensure people downstream are "doing what they should be doing" as well.
It seems as if though the FDA wants Elite to not only ensure they do their job in manufacture the drug to FDA standards they also believe that Elite should ensure everyone else downstream takes their own responsibility as well.
Sounds like the FDA is asking for a bit much.