Purdue's "abuse proof" oxy IR reviewed by FDA for overdose concerns

[thetalkingasshole (OP)]

http://www.aboutlawsuits.com/avridi-dosing-concerns-86987/

I'm on a phone so no copypasta but someone.... SOMEONE... will post it all

Basically the FDA is reviewing this *shudders* patented formulation
the main concern is a result of people taking the drug on an empty stomach
It's stated in the medication guide that it must be taken WITH food

I don't understand how a supposedly abuse-proof instant release pill
can make such a dramatic difference in the dose delivered that there is risk of OD

Either way I tbought it would be a good point to bring up
not sure how many people here EAT there meds, but there ya go
I know oxy is somewhat lipophilic but this seems a little fakakta

[Jega]

Avridi Overdose Problems Raise Concerns Among FDA Reviewers
September 9, 2015
Written by:   Irvin Jackson

Federal drug reviewers are concerned that a proposed new painkiller, Avridi, could pose an overdose risk because food intake may interfere with its painkilling effects.

FDA investigators released a report (PDF) ahead of a September 10 FDA advisory board meeting, which warns that Purdue Pharma’s proposed fast-acting oxycodone painkiller could lead to overdosing among patients who eat close to the time the pill is taken.

The reviewers indicate that the pill needs to be taken on an empty stomach, but history suggests that many users are not used to following food directions when using opioids. This may result in the painkiller not working effectively, potentially leading to dosing problems.

An independent committee of FDA advisors are scheduled to meet on Thursday to review the drug’s safety and effectiveness, and will then recommend to the agency whether the drug should be approved for sale. The advisory board’s recommendations are not binding on the FDA, but their votes usually factor heavily into the agency’s final decisions on new drugs.

In the report prepared for the advisory committee, FDA staff reviewers expressed concern that users would eat soon before or after taking the pill, feel no effects from the medication and potentially take another dose to increase the pain killing effects, thus increasing their risk of overdose and addiction.

“The abuse of prescription opioid products is a growing public health problem in the United States, but it is of great importance to maintain the availability of opioid analgesics for the millions of patients in this country who suffer from pain,” the FDA reviewers wrote. “FDA has encouraged drug companies to develop opioid analgesics with properties intended to deter their abuse.”

Purdue has suggested that the drug carry label warnings indicating that it is to be taken on an empty stomach, and that users should wait 4-6 hours between doses. However, the reviewers doubt the label warnings would be effective.

“Opioid analgesics are generally taken without regard to food, and it is not clear whether labeling would be sufficient to change long-standing behaviors of both prescribers and patients,” the review indicates. “All of these issues may result in patients taking Avridi without regard to food, leading to variability in systemic exposure to oxycodone, variable or delayed efficacy, and the possibility of taking extra doses that could lead to serious adverse events.”

Painkiller Abuse, Overdoses, At “Epidemic” Levels

According to the findings of a recent report by the Robert Wood Johnson Foundation and Trust for America’s Health, nearly 44,000 drug overdose deaths occur each year, with half of those linked to prescription drugs. West Virginia was the state with the most drug overdose deaths, with 33.5 per every 100,000 residents.

The report indicates that more than two million people in the U.S. abuse prescription drugs, and that abuse has fueled a resurgence in the popularity of heroin. The drug overdose death rates have been on the rise for four years in 26 states and the District of Columbia. In only six states have the rates gone down.

In 2012, the U.S. Centers for Disease Control and Prevention (CDC) released a report which indicated prescription drug overdoses have reached epidemic proportions. Prescription drug overdoses kill someone in the U.S every 19 minutes.

Overdoses, intentional and unintentional, by painkillers have driven death rates to numbers higher than those of cocaine and heroin combined since 2003.

In April, the FDA issued final guidance on opioid painkillers with abuse-deterrent properties. The guidance focuses on bringing new abuse-deterrent drugs to market quickly, while balancing access to opioid painkillers and reducing misuse and abuse.

- See more at: http://www.aboutlawsuits.com/avridi-dosing-concerns-86987/#sthash.w0tu4ym6.dpuf

[NZniceguy]

http://www.aboutlawsuits.com/avridi-dosing-concerns-86987/

I'm on a phone so no copypasta but someone.... SOMEONE... will post it all

Basically the FDA is reviewing this *shudders* patented formulation
the main concern is a result of people taking the drug on an empty stomach
It's stated in the medication guide that it must be taken WITH food

I don't understand how a supposedly abuse-proof instant release pill
can make such a dramatic difference in the dose delivered that there is risk of OD

Either way I tbought it would be a good point to bring up
not sure how many people here EAT there meds, but there ya go
I know oxy is somewhat lipophilic but this seems a little fakakta

I read it as saying the opposite.....they WANT people to take it on empty stomach because if taken with food, it might not work as good, so people will take more and potentially O.D.

[Z]

How do they come up with these names?  Douglas Adams scrabble bag technique? 

As a random guess I bet they are using a digestive enzyme to cleave the molecule like vyvanse.  Full stomach= lack of enzymes= no dose.  Watch me be totally wrong.

[Wildcat]

What??

I take mine usually on empty.........so, they are saying folks that take opiates don't have the sense to remember when they eat or not?? Every time they try and change a med that works well, it affects it badly-they may have abuse proofed oxycontin-but it is also now a pretty useless painkiller, now they will do the same too the IR?

Great.

[ms-copin]

Hopefully you guy will still have the generics to muck around with over there for a little while if they do end up going through with that, but i reckon it won't take long for someone to figure out a quick and easy way to abuse it 

[Narkotikon]

I'm betting it will be like Vyvanse too. 

And yeah, they want you to take it on an empty stomach.  Taking it with food won't let it work as well.  Some people will inevitably take more.  They could OD. 

[makita]

Its just so fucking stupid.  People need to be able to take an IR med when they're IN FUCKING ACUTE PAIN, regardless of whether they've eaten or not.  If people dont comply with eating instructions its because they are in too much pain to eat/wait for their food to digest.  Why is it companies are willing to sacrifice the very purpose of the drug for abuse proof (read: patent$) purposes. 

Idiots.

[makita]

Its just so fucking stupid.  People need to be able to take an IR med when they're IN FUCKING ACUTE PAIN, regardless of whether they've eaten or not.  If people dont comply with eating instructions its because they are in too much pain to eat/wait for their food to digest.  Why is it companies are willing to sacrifice the very purpose of the drug for abuse proof (read: patent$) purposes. 

Idiots.

They are banking on Drs who are scared of the DEA and who've swallowed the "opioid epidemic" fallacy to put their patients on this crap instead of the perfectly fine, works all the time no matter what you eat or dont eat, generic alternative. 

[thetalkingasshole (OP)]

To quote the immortal Rick Perry

"Oops."

[Seven]

I dont think you guys are reading it right.  Or maybe its me.

What the article is saying is that the fda is afraid people will take their pill on an empty stomach or eat soon afterward, wont feel the effect and will then take another one and possibly OD.

[Bhoris]

What the article is saying is that the fda is afraid people will take their pill on an empty stomach or eat soon afterward, wont feel the effect and will then take another one and possibly OD.

I think the article is saying that the medication should be taken on an empty stomach and that taking it on a full stomach could cause the medication to be less effective which could then cause people to take more and then potentially OD.

[Sand and Water]

Its just so fucking stupid.  People need to be able to take an IR med when they're IN FUCKING ACUTE PAIN, regardless of whether they've eaten or not.  If people dont comply with eating instructions its because they are in too much pain to eat/wait for their food to digest.  Why is it companies are willing to sacrifice the very purpose of the drug for abuse proof (read: patent$) purposes. 

Idiots.

They are banking on Drs who are scared of the DEA and who've swallowed the "opioid epidemic" fallacy to put their patients on this crap instead of the perfectly fine, works all the time no matter what you eat or dont eat, generic alternative. 

^^^ EXACTLY.  Let's suppose for a minute that money isn't a motivation here (I know, but I'm gonna try)   First of all, most pharmacy inserts instruct you to take meds with food TO AVOID stomach upset. Particularly NSAIDS, so we've been trained to do this for a very long time. 

Secondly, when looking at this med for use with severe pain and CP, folks who are in pain, often have lousy appetites (along w/that comes subpar nutrition, which hinders healing etc etc), so it seems stupidly counter productive to make a med that's supposed to relieve pain but ignore a basic need like food. Just seems like they're pushing the "we got a pill for that" mentality and using the threat of abuse by the masses as the excuse. 

[Snoop]

The older I get, the less stupid shit like this surprises me.

Soon, we'll all be so Fucking SCARED some little white rich kid will OD, that we'll just be taking sugary placebos and diluted tinctures.

For just about anything.

CPP'ers are in for a rough road down the line just a little bit further.