Opioids Is there anyone else FLIPPING OUT yet about the soon to become Opana ER shortage

[dez79]

I could only dream of my doc prescribing Oxymorphone! I have to be in excrutiating pain to get codiene these days ! FTW.

 

[timetohunt]

Where I live, we have no shortage of Opana ER. However, the 10mg IR's can be a pain to find at times. As far as asking your Dr what to replace it with, depends because there's nothing RX higher than pandas. You could possibly ask for an increase on IR if you get them or ask for oxycodone as breakthrough.

Might be that your area is closely associated with Impax Global. Could you say in general terms what part of the country we are talking about.

 

[Slow_Mobius]

Kittycat5, I must say I'm intreagued as well. Funny, but I have the global brand as well. According to a/the Opana ER website, their test showed that a name brand Opana ER pill, the one with the safety mechanism in it was a little stronger and slightly smoother than a generic Oxyorphone pill, the kind with the original formula and of equal strength. I'm not sure I believe it, but can see the name brand pills being ringers.
I'm going slightly off here but I have a theory. I think that name brand pills may in some cases work better then their generic counterparts because of the solubility levels of the binders and fillers in a name brand pill versus a generic pill. Why couldn't certain binders or fillers increase or decrease certain aspects of a medications bioavailability? I will have to do a little research into a few of the fillers. Theoretically, could this be a possibility?

People often underestimate drug delivery. There must be thousands of different drug deliver mechanisms JUST for drugs taken orally in pill form. Not just the fillers and binders used, but drug dispersion and production method can have huge implications on maintaining the desired therapeutic window. Pharma companies dump tons of money into researching methods for reducing the peak/valley effect people often get with any drug they take.

 

[MrRoot]

Well what about patenting extended release mechanism instead of drug?

Wouldn't that yield longer exclusive rights?

And after that you just use big money to lobby FDA to drop out same drugs with other ER mechanisms as they aren't safe or they are sub-par effective and lobby doctors to not prescribe IR releases because of their abuse potential.

P.S. If you Big Pharmas aren't doing that yet then let your head hunters contact me through PM so they can employ me.

 

[Shaleh]

Might be that your area is closely associated with Impax Global. Could you say in general terms what part of the country we are talking about.

South/USA.

My experience dealing with the pharmacy has been annoying. My insurance pays for the white 10mg instant release (Roxanne Labs), but the pharmacy always tries to fill the pinks or peaches. I had to get my case manager to get on them about filling the whites and keeping them in stock. I have zero issues now.

Most pharmacies will keep a specific amount on hand for customers who have monthly refills and have used them for awhile. They'll tell you they don't have any when truthfully, they have enough to fill several scripts.

Have you asked for instant release instead of extended? I do know some PM offices can set you up with fed ex , UPS monthly deliveries from an outsourced pharmacy that's guaranteed to have them in stock 24/7. The only set back with that is a delay in delivery.

 

[BeachBum4u]

Most pharmacies will keep a specific amount on hand for customers who have monthly refills and have used them for awhile. They'll tell you they don't have any when truthfully, they have enough to fill several scripts.

Even though my pharmacy tells me to always call ahead of time and tells me they can't save meds for any particular prescription, I believe I'm the only one they have on my med and so far, they always seem to get in one bottle each month to fill my request. God Bless them!

 

[ninePM]

A bit off topic, but as some one who broke their back this scares me. It was so hard in Maryland to get just Oxy 15's. I went from pharmacy to pharmacy with a real script for 45 pills. One pharmacy I had to been going to for three years all of a started treating me like a criminal and lying about my insurance because I came in with a script FOUR days before my second refill EVER! They wouldn't just tell me that there was a database and it was FOUR day too soon. So I thanked them for finding what they called "red flags" took back my script and "walked " out with the assistance of a walker and a back brace, like most people do who are abusing/selling this little dosage. I fear having to be on these drugs for a long time, but because of the surgery I'm partially crippled for life.

Is this a DEA thing or just pharmacy co. greed? I used to live in NewHampshire and knew of alot of people that that switched to heroin after the Government made the Oxys impossible to get. Regular people who are now criminals or dead because of OD'ing.

 

[Shaleh]

Even though my pharmacy tells me to always call ahead of time and tells me they can't save meds for any particular prescription, I believe I'm the only one they have on my med and so far, they always seem to get in one bottle each month to fill my request. God Bless them!

That's awesome! When I 1st started getting them, they were rarely prescribed in my area. I caught H just trying to fid the 5mg opanas. You have to meet a certain criteria for oxymorphone in my state. I don't have any issues with getting them filled now.

I believe the OP asked what could replace them? I don't forsee any pill replacing them in "my" area because where I live you're either on oxycodone 5mg to 30mg, dilaudid 2mg to 8mg or oxymorphone 10mg to 40mg.

 

[timetohunt]

A bit off topic, but as some one who broke their back this scares me. It was so hard in Maryland to get just Oxy 15's. I went from pharmacy to pharmacy with a real script for 45 pills. One pharmacy I had to been going to for three years all of a started treating me like a criminal and lying about my insurance because I came in with a script FOUR days before my second refill EVER! They wouldn't just tell me that there was a database and it was FOUR day too soon. So I thanked them for finding what they called "red flags" took back my script and "walked " out with the assistance of a walker and a back brace, like most people do who are abusing/selling this little dosage. I fear having to be on these drugs for a long time, but because of the surgery I'm partially crippled for life.

Is this a DEA thing or just pharmacy co. greed? I used to live in NewHampshire and knew of alot of people that that switched to heroin after the Government made the Oxys impossible to get. Regular people who are now criminals or dead because of OD'ing.

It is both a DEA thing and drug company greed. Endo continues to try to maximize profits, which is not OK in this case because they are doing it at the expense of the wellness of many people. They make decisions based on money alone. As far as the DEA in my area (which is at the eastern edge of the Hillbilly Heroin region) is a hotspot for DEA investigation.
There has been at least 2 notorious doctors in the area which have been caught abusing their script writing privileges in association with pain medication. Many doctors that used to sript pain meds have stopped. There is one town that is more or less a pain med hub in regards to LEGAL pain med distribution. They have pretty much been grandfathered in. They also follow DEA rules or at least feign to do so. The waiting rooms of these places remind me of what you might see at a bus station in New Jersey. It literally smells at times. You just know its below average as far as the character of the group as a whole. I can't see why these people can't just take a shower and wear some decent clothes when they come into these pm offices. Another thing to give pm patients a bad name. Is it any wonder why we are looked down at. I might too if I was on the other side.

 

[timetohunt]

That's awesome! When I 1st started getting them, they were rarely prescribed in my area. I caught H just trying to fid the 5mg opanas. You have to meet a certain criteria for oxymorphone in my state. I don't have any issues with getting them filled now.

I believe the OP asked what could replace them? I don't forsee any pill replacing them in "my" area because where I live you're either on oxycodone 5mg to 30mg, dilaudid 2mg to 8mg or oxymorphone 10mg to 40mg.

I already get a pain med for breakthrough which is hydromorphone. My plan was to ask for opana IR instead. I have only been with them 4 months, so I am taking it slowly and not pushing. There is not much that can repace the opana ERs, once you are on them, everything else pales in comparison.

 

[Slow_Mobius]

Well what about patenting extended release mechanism instead of drug?

Wouldn't that yield longer exclusive rights?

And after that you just use big money to lobby FDA to drop out same drugs with other ER mechanisms as they aren't safe or they are sub-par effective and lobby doctors to not prescribe IR releases because of their abuse potential.

P.S. If you Big Pharmas aren't doing that yet then let your head hunters contact me through PM so they can employ me.

Extended release mechanisms are often incredibly simple. For many drugs it's as simple as altering fillers and drug dispersion within the tablet. It's maintaing a zero order release relative to secretion or metabolism of the active compound that can be especially tricky. These sorts of tablets are significantly more expensive to manufacture, so pharma will only make an effort to create a zero order release tablet if its a drug with a very small therapeutic window. When it comes to pain meds, it's your own fault if you OD, so why would the pharma companies invest a significant amount of money into manufacturing a zero order release pain tablet when they'll generate the same revenue from their IRs and shit ERs. Pharma companies have essentially monopolized on our pain, because we'll buy their painkillers even if they're crap formulations because we'll take whatever relief we can get

 

[Kittycat5]

So to finish the story, Endo seemed to buy itself 3 years by bribing Impax to keep their generic off the market and settling with the other manufacturers by claiming they will not sue them further for patent infringement. But this wasnt good enough. Endo then decided to reformulate Opana ER making it less abusable. Impax foresaw this and based some of their payment on the quarter before they would be allowed to make the generic based on brand Opana sales.

Endo was trying to cash in on the FDA desire to make abuse deterrant products but to the FDA'S credit, they said reformulated Opana did not meet their criteria for abuse detterence and generic Opana can be made. Endo then took Actavis to court saying their two new patents on abuse proof Opana were not covered by their original agreement on not to sue, and won against Actavis. That is where we stand now. I imagine they didnt go after Impax yet for obvious reasons, but who knows. This is common practice in the world of big pharma, but slimy even for their standards.

 

[BeachBum4u]

This is common practice in the world of big pharma, but slimmy even for their standards.

Damn, why in the world do things have to be this difficult? It just drives me crazy! I don't really fully understand everything you wrote above but I do appreciate the detailed explanations you provide.

I imagine they didn't go after Impax yet for obvious reasons, but who knows.

As I wrote above, some of this is a bit over my head but you mention above "for obvious reasons" (remember I'm a little slow here) what exactly are those reasons and is there a scenario where they would go after Impax too?

 

[Kittycat5]

Because they paid them 130 million + just to simply not put out the generic, which protected their profits for roughly 3 years. They would surely be in a much larger fight had they decided to take Impax to court before Actavis.

Let me summarize. Endo decided to bring back oxymorphone after 20+years of it being off the market.

FDA grants 20 year exclusivity to completely new drugs, but give exclusive rights for less time under certain circumstances, in this case 3 years.

Opana IR and ER were brought to market the same time in 2006. If you read the section I wrote about Opana IR, that is exactly how Opana ER should have gone.

But Endo licensed some patents from Penwest for the ER technology as used them as leverage to fight off generic competition. Even though they didnt follow the rules for listing these patents, they eventually did and just suing a generic company on grounds of patent infringement stops that particular company from producing their generic for 30 months. Endo did this to all companies wishing to produce generic Opana ER.

The first company (in this case Impax/Global) to file with FDA to make a generic gets 180 days to produce the only generic version.This stands no matter what even if the patent litigation takes the full 30 months (which it did in this case as well).

Knowing they were going to lose to Impax, Endo decide to pay them over 130 million dollars to keep their generic off the market for another 3 years. They also settled the cases against the other generic companies allowing them to market a generic at a time that was often before they would have been able to (moot point as Impax still had the 180 day window) but more importantly Endo would not persue further litigation on patent infringement of their current patents for Opana ER or any extension of those patents in the future.

Before the three years was over, Endo reformulated Opana ER to the current crush resistant formula which included two new patents. Actavis went ahead with releasing a generic of the original Opana ER (as did Impax) thinking the agreement talked about above would extend to these new patents as well. Endo dsagreed and went to court and won against Actavis, saying the new patents for the crush resistant Opana ER were not mere extensions of their previous ones and hence is why Actavis must cease making oxymorphone ER.

Because they basically bribed Impax, they havent as of yet been forced to stop making their generic via court order, but I wouldnt be suprised if this happened.

 

[BeachBum4u]

Because they basically bribed Impax, they haven't as of yet been forced to stop making their generic via court order, but I wouldn't be surprised if this happened. Please tell me this won't happen, please, pretty please!

I sure hope little ole' me can keep getting my lowly 60 ct. bottle of 40 mg Opana ER Rx filled with the Global generic for the foreseeable future. They sure could make me a very happy man!

 

[Kittycat5]

As of right now, no. As I said the FDA sided with the generic companies saying reformulated Opana ER was not actually abuse deterrent and the case of Endo v Actavis in court made no mention of Impax not being able to continue making generic oxymorphone ER. To be honest, I think the generic from Impax is safe, as all of this shit has been a positive for Endo more than anyone else, and they may not want to keep spending money defending it.

 

[Cliffy78]

Not to be missed in all of this is the 1000 pound Gorilla sitting over there in the corner of the room. And it is; the Oral method of administration (MOA), is very important in this discussion. Opana has an approximate oral bio-availability of about 10%. Honestly a 20mg Opana taken orally, (regardless of formula for the most part), is not much stronger, if at all, then a small/moderate amount of hydrocodone taken orally.

The Bio-Availability of Opana sky rockets to above 70% with just about any other MOA you can think of. This is a vast chasm, which makes Opana stonger than high purity heroin when used in ways other than oral administration. It is almost unreal, and I suspect that many pain management patients have recognized this and do what they must to handle their pain. Some of you might remember when Opana changed to the plastic-like formula, there was mass withdrawal happening all over the country. People wound up chewing multiple plastic pills just to stave the terrors of opiate withdrawal. Then they would obviously run out, and find themselves in an even worse spot. Sure, we can say they put themselves into that position, but I suspect that the majority of those people, other than misusing their meds, were far from criminals. Some wound up in criminal activity because they were drawn to look for something that could match the tolerance they built with snorting or injecting Opana.

Again, lets be honest, Opana would not even be a story or a well known pain killer if the bio-availability were 10% no matter what the MOA was. The fact is, it is practically unmatchable among pill-based opiates regarding strength when insulflating, plugging, or shooting. One of the popular aspects of this drug was indeed it did not even need to be injected to get what most narcotic users, legit or otherwise, were seeking. Similar to the rise of modern Heroin. The older (IDK, say pre-90s) Heroin kept many people away from the drug because it had to be injected. A lot of kids experimenting with drugs were just not willing to take that next step to sticking a metal point into their veins. Newer Heroin could be snorted, drew a lot of new fans and then many of those folks wound up shooting anyway because they were already chasing the opiate high or in the case of people with pain, the relief.

I also seem to remember, be it real or perceived, a collective "horray!" among opiate users when the generic companies were allowed to start making the non-plastic formula. The whole thing is a complex quagmire of variables. I am thinking of writing a book (not kidding) as I see the story of Opana has enough tentacles to make for a highly interesting tale of abuse, money, pain, deceit, corporate immorality, and other "sexy" things that have impacted peoples lives. The impact can only be described as mostly negative. The thing is, I don't think it had to be that way. Early management of those who reintroduced this drug could have at least changed some things for the better. Overall, I think that the mismanagement is a result of people caring more about money than other people. A common theme, yes. But the issues have run very deep for many.

Hi kitty, I hope u had happy holidays!
If you do end up writing that book be sure include suboxone and their little trick of adding a minuscule amount of naltrexone and then got a new patent for Bupe with some bullshit that's not really doing anything, what a joke! But I'm preaching to the choir here so I digress lol. Just thought I'd remind u about that scam the FDA or dea or whoever pulled that off onall of us, they are literally making billions of dollars off of just subs.
I really would enjoy that book if u end up writing it so please send cliffy a copy!!! I just did my morning bags so pardon me if my post is slightly incomprehensible and a bit jumbled together...

 

[timetohunt]

No problem with a jumbled text, actually its fine.
The book thing is no joke, though I may be relegated to doing something akin to a Newsweek or Time article.

If I were going to write it, I would need a stash of $$ to work off of. I would be traveling and doing interviews and local
archive type of research. This would not be that difficult to write since I am plum right in the middle of it in many ways.
I think that point is obvious from my posts.

thanks

 

[NovaStar]

After 2 years of trying to find pain relief, Opana ER 30 mg every 12 hours and Opana IR 10 mg 4x daily worked well. I was taking less Opana IR with increase from 15 mg Opana ER to 30 mg. Got in trouble with the Dr after 1 time use of Meth ( d.u.m.b Dum!) When I mentioned Opana to a new Dr (not Chronic Pain Mgmt) they gave nothing, then trammadol (a dirty opiate for me). I have a HOST of chronic pain issues. See new pain Dr on Thursday (I've been without pain Mgmt since Sept 5th) & desperate for pain relief. I had no idea Opana was stronger than Heroin (which I learned on this thread). I'm a long term opiate user & very opioid tolerant. Know all the tricks to get an extra 'boost'...etc. 3 people actually suggested Heroin for pain if Dr's won't prescribe me pain meds. Even as a lover of glorious opiates, Heroin was a NO until I learned Opana is stronger than Heroin! The Dr's may drive me to it as my pain is ruining my quality of life.
I'm sick of the DEA & the pharmaceutical companies making chronic pain a game to them & scaring Dr's from prescribing pain relief.
Just my 2¢. I'm a newbie so I hope I didn't break any rules. TY...

 

[timetohunt]

After 2 years of trying to find pain relief, Opana ER 30 mg every 12 hours and Opana IR 10 mg 4x daily worked well. I was taking less Opana IR with increase from 15 mg Opana ER to 30 mg. Got in trouble with the Dr after 1 time use of Meth ( d.u.m.b Dum!) When I mentioned Opana to a new Dr (not Chronic Pain Mgmt) they gave nothing, then trammadol (a dirty opiate for me). I have a HOST of chronic pain issues. See new pain Dr on Thursday (I've been without pain Mgmt since Sept 5th) & desperate for pain relief. I had no idea Opana was stronger than Heroin (which I learned on this thread). I'm a long term opiate user & very opioid tolerant. Know all the tricks to get an extra 'boost'...etc. 3 people actually suggested Heroin for pain if Dr's won't prescribe me pain meds. Even as a lover of glorious opiates, Heroin was a NO until I learned Opana is stronger than Heroin! The Dr's may drive me to it as my pain is ruining my quality of life.
I'm sick of the DEA & the pharmaceutical companies making chronic pain a game to them & scaring Dr's from prescribing pain relief.
Just my 2¢. I'm a newbie so I hope I didn't break any rules. TY...

You realize that if Oral is your MOA, might be a waste of your time. I am not trying be an advertisement for oxymorphone pills, and it sounds like you are a bit enthusiastic to hear about their strength. Also....
1. very expensive. They have become less expensive throughout the years, but are still quite costly. I remember my monthly was $1400 about 5 years ago, with insurance I was still paying about $250 for them. I think without insurance, they still run in the hundreds for say 90 20mg pills.
2. the plastic variety is what you may end up with if you are not paying attention. (even dedicated Oral users are having issues getting the med properly into the blood stream). Our digestion can vary with age, lifelong diet, among many factors. Stories have been tossed around about people seeing almost the whole pill show up in their stool. I myself have not verified this personally, but I think it is more truth than fiction. I don't think our systems were designed for such synthetic bindings.

I also have this philosophy, be it twisted or levelheaded....you tell me. But I think people over a certain age should be allowed more freedoms with pain meds. Less so for the under 40 set. I realize that people under 40 can have massive pain issues as any 70 year old might. But there is so much more to consider unless that 'young' person is on their death bed. If you plan on living with as much hassle free life as you can grasp, and you have a lot more time left.....let me tell you, opiates will impinge on that endeavor. In so many ways. Not only that but you will hit 35 feeling and looking more like 55. I realize there are a few folks who can ride this thing and still come out looking okay, but that is the minority.
NOTE: most (but not all) of the above is related to the ER variety. Just wanted to make sure that was clear.