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

[timetohunt]

Is there anyone else flipping out yet about the soon to become Opana ER shortage. Where I come from that soon to become is NOW. As usual you hear bits and pieces from fellow pain management people to pharmacy workers, even a call into Activis that I made.

I want to leave this brief so that I am not out here filling the holes in the story with fiction. So I will do it like this in bullet fashion, perhaps the same can be done from others (or however you would like to add your knowledge).

Fact: From the news it appears to be true that Endo (Opana original maker) won a suit against Activis (a gerneric maker of Opana, the moons).
I don't exactly know how the dominos fall with this, but every single pharmacy is saying they will have troubles
getting oxymorphone, esp ER.

Fact: There is no doubt from multiple observations that Opana ER is hard to get and has been for about 2-3 weeks (may vary for your region). And I mean getting your legitimate legal script filled. I have no idea about the streets, but you know some where, some way, somebody is going to be handing over 150 bones for one forty. That is not my worry. I'm worried because there is nothing that works as good for me, and whatever this lawsuit is will likely have me in withdrawal going down to the MS garbage, I'm seriously thinking of asking for Methadone.

When I first posted about this a few weeks back, a very reliable source added much information to the topic. I will come back and post that thread here.
EDIT:
http://www.bluelight.org/vb/threads...ustated-What-is-going-on-here?highlight=opana

The informative and reliable source I mentioned has already checked in to this thread. TY.

So, my main questions for now:
1. How long will this dirge last
2. The original agreement was for the old original opana script to be made by Activis, Global and others well into the 2020s,
how will this be impacted.
3. Does this impact the IR (not ER) market/availability in any way.
4. What do we tell the doctors to replace it with?

 

[Kittycat5]

1. Dont know. Will check tomorrow.
2. Afaik, Global still can make Oxymorphone ER but will check that out as well. I imagine they will ramp up production if they arent next in line in court but this will take some time.
3. Probably some crossover to IR as people switch to it when they cant get the ER.
4. Any other long acting opioid you tolerate and works. Oxycodone, Hydrocodone, Hydromorphone, Morphine, Fentanyl all have long acting products.

 

[timetohunt]

I really wonder if any of the movers and shakers that cause this type of turmoil/instability in the pharmacy ranks know HOW GOOD FOR BUSINESS IT IS FOR HEROIN DEALERS. If I'm an H dealer, I get very happy about these types of things going on in the pharm world.

 

[Felonious Monk]

I really wonder if any of the movers and shakers that cause this type of turmoil/instability in the pharmacy ranks know HOW GOOD FOR BUSINESS IT IS FOR HEROIN DEALERS. If I'm an H dealer, I get very happy about these types of things going on in the pharm world.

Small events like this have less impact on your neighborhood dealer than you're implying. Figure that Opana ER is not a very popular drug. And switching to heroin is not something that even a significant minority of people do. So it means probably 1 extra regular customer for the local dealer, but given ebbs and flows in the overall market, plus customers that switch between dealers, and I'd bet nobody even notices.

 

[CfZrx]

4.Switch to methadone, it's soooo good for pain, and no rollercoaster ride, just 24 hours addiction relief and 6 hours of pain relief with every 10mg ymmv.

 

[Cliffy78]

I really wonder if any of the movers and shakers that cause this type of turmoil/instability in the pharmacy ranks know HOW GOOD FOR BUSINESS IT IS FOR HEROIN DEALERS. If I'm an H dealer, I get very happy about these types of things going on in the pharm world.

Between this and everyone getting kicked off due to stricter rules and drs being so afraid to the new op oxy formulation not working for so many people and people like me that hadn't had a dose titration for 8yrs and no longer get relief from my script and people that can't get scripts that truly need them due to fear of the dea the h dealers are gonna be ballin out of control, no doubt about it in my mind I see it everyday and I personally switched to h from oxy for the reason above! And the news here in mass. Goes opiate crazy everyday saying drs are overprescribing and opiates are satan etc etc. Everyone's moving on up to h or they're having a helluva time trying to kick where I'm from. It's fucked up legit patients are forced into this to get decent pain coverage! Legalize everything already and let's get with it then, that's inevitably what's gonna happen anyways IMO. Maybe not 10yrs and maybe not 20 but eventually it's gonna happen so people are just suffering needlessly now thx to laws that are ridiculous right now, forget about 50-100yrs from now. Were protecting all the opium fields in Afghanistan so let's bring it all on home and start selling opiates OTC at cvs and walgreens already! Sounds funny but I'd bet the farm that 100yrs from now this will be the norm IMHO...

 

[Speed King]

I'm on the generic Oxymorphone ER 10 Mg, twice daily. I will call my pharmacist and doctor office tomorrow and be my own advocate here. I am on a low dose and only about to get my third refill. I guess it would be in my best interest to taper down now. This is a game that is being played. Time to get off for good.

 

[Speed King]

Called my pharmacist at 9:15am and explained. He said his supplier was stocked and my order was good

 

[timetohunt]

Called my pharmacist at 9:15am and explained. He said his supplier was stocked and my order was good

Was curious as to which part of the country you hail from. Dont have to give anything specific, generalize. thanks

 

[Speed King]

North east. East of Mississippi River .

 

[Kittycat5]

I'm on the generic Oxymorphone ER 10 Mg, twice daily. I will call my pharmacist and doctor office tomorrow and be my own advocate here. I am on a low dose and only about to get my third refill. I guess it would be in my best interest to taper down now. This is a game that is being played. Time to get off for good.

I checked and my wholesaler had the Global brand in stock but couldn't ascertain if it too would be subject to shortages due to increased demand.

SK is absolutely right in that this is a game and the players are cheating. He and I were discussing it the other day and Endo, the makers of Opana have really held nothing back in order to maintain their monopolistic profits from Opana at the expense of the patients who need medicine. If you guys are interested, I could explain exactly what Endo did.

 

[Felonious Monk]

SK is absolutely right in that this is a game and the players are cheating. He and I were discussing it the other day and Endo, the makers of Opana have really held nothing back in order to maintain their monopolistic profits from Opana at the expense of the patients who need medicine. If you guys are interested, I could explain exactly what Endo did.

Could you discuss it a little? I'm curious. All I know is it's vaguely similar to the Purdue OxyContin story, both ended up with a brand name ER formulation that was ineffective due to abuse controls...

 

[Speed King]

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?

 

[Kittycat5]

Ok, so this is what happened with Opana and ultimately why there is a potential shortage of Oxymorphone ER.

The maker of Opana is Endo International. Earlier iterations of Endo first marketed oxymorphone in the 50's as an injection and a suppository, then from the early 60's to 1972 as an immediate release tablet, when the company withdrew it voluntarily. Sometime in the 90's, Endo decided to bring oxymorphone back. Since it was quite an old drug, the patents had long expired. But FDA does have provisions that allow a three year exclusivity period for companies that submit and win approval for a New Drug Application, which must be backed by clinical studies, in cases similar to this (side note, wonder if this could be done for MDMA? Not sure of all the details but interesting) and in 2006, Endo did exactly this and launched Opana IR and ER. Now is when the fun begins.

Endo had no chance of anything more than the three years of exclusive rights to sell Opana IR, and events unfolded as one would suspect. The three year monopoly expired, a company (Roxane) was the first to submit to launch a generic (more on this later), Endo simultaneously started distributing its own generic, and prices began to drop. Within a year, several other drug companies also put out generics and prices of oxymorphone became relatively reasonable.

Opana ER provided Endo with much more opportunity. The purchased four patents related to extended release technology from Penwest, but only listed one of them with the FDA's Orange Book, which curiously was set to expire before the three year window was to be over. It is required for a manufacturer to list all patents pertinent to their newly approved drug in this book within 30 days. This normally would be an important way to protect their property. You see, the first filer for a generic version of a branded drug is afforded the benefit of 180 days of exclusive rights to market the generic provided it is bioequivalent via the Abbreviated New Drug Application (ANDA) process. But they must also show they are not infringing on the patents listed in the Orange Book. This can be proven if there are no patents on the brand product, the patents are expired or will be expired by the time the generic comes out, or the patents could never even be thought to be infringed upon by a generic alternative or those patents are invalid.

So not filing all their patents, it seems Endo would have a much harder time fighting off generic competition, but exactly the opposite happened. They eventually listed the patents in the Orange Book near the time Impax, the first generic filer, was getting ready to launch. Impax proceeded anyway, telling Endo that their late listing of the patents invalidated them and the one patent filed on time was expired. Endo then sued Impax for patent infringement setting off a cascade of events that are both comic and tragic.

Even though they listed those patents late, the mere act of taking a generic company to court triggers a 30 MONTH!!!! stay in which the generic company cannot sell its product. Endo did this to every generic manufacturer as they submitted an ANDA, and each time it triggered a 30 month stay. Of interest, Endo did not persue infringement of all their patents in each case, just one or two of them. Most likely this is because whatever firm they were suing had licensed or developed similar technology which would make invalidation easier. This already seems like nothing but gaming the system, but it gets worse.

Remember that 180 day exclusive period the first generic company gets? Well, they are entitled to that no matter what. So as more tried to get their ANDA approved, it was little more than wishful thinking as Endo could drag the court case against Impax for the full 30 months, let the time expire, and everyone other than Impax would still have to wait 6 more months before selling a single pill. As stated earlier, there is nothing to stop Endo from selling the actual brand drug, repackaged as a generic (called an authorized generic) during the 180 day window, holding on to some profits. But the consumer gets fucked as manipulation of FDA rules and frivolous lawsuits allowed only Opana ER to be sold at monopolistic prices for 30 extra months, and prices would still remain high when Impax first sold generic Opana, as they would be the sole competitor, which anyone with basic understanding of economics knows doesn't put a huge dent in prices.

But it still isn't over. The 30 month stay against Impax was nearing. They were convinced it would be an easy win in court and were readying to start selling their product no matter what. Endo was aware they most likely would not win and that soon their market share for Oxymorphone ER would be severely eroded. In order to combat this, they basically bribed Impax to hold off on selling their generic for 3 years. Impax agreed to also not to continue to fight the patent litigation and in return received as much as 130 million dollars and assurance that after three years were up, Endo wouldn't launce an authorized generic to compete against their generic (which they still would have 180 days exclusivity!!!). Endo then proceeded to quickly settle the cases against all the other generic companies. In return for the several generic companies not continuing their cases against Endo's patents, Endo would allow them to produce their products at a set date which was often earlier than they would have otherwise been able to do so. Endo also agreed to not sue them for stepping on their patents and had a clause that any future innovation of Opana's patented technology would be allowable for the generic companies to use as well. But the wording was crucial and takes us up to why now Actavis is legally barred from selling oxymorphone ER.

I will finish the story after work.

 

[BeachBum4u]

Kitty, I read your whole post and if I missed it, I apologize but I didn't see any mention of where things stand with Global (which just happens to be the company my pharmacy uses). I do appreciate you walking through the entire story although I must admit, I wasn't able to follow it as well as I would have liked to. Thanks again for your pharmaceutical wealth of knowledge!

 

[Kittycat5]

Yeah, Im getting to that. Impax is Global btw.

 

[timetohunt]

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.

 

[Felonious Monk]

Very interesting, thank you for that kitty.

I have to agree with you timetohunt, there's honestly no legitimate reason to even make oxymorphone tablets, if we acknowledge it's a crime to use the medication in any manner other than the way in which it was prescribed.

 

[timetohunt]

Very interesting, thank you for that kitty.

I have to agree with you timetohunt, there's honestly no legitimate reason to even make oxymorphone tablets, if we acknowledge it's a crime to use the medication in any manner other than the way in which it was prescribed.

I may not be quite understanding your overall take on this, though it always feels good to be agreed with. I am not so much leaning toward it being a crime if you are finding different ways of taking the med. This is complex, no doubt. Once a person gets their meds legit from a doctor/pharmacy, it would be near impossible to police how a med is taken. Crime is not where I am going with this. Consider that many folks who can't swallow pills cut them in half or crush them. For many meds this is actually allowed. People already know that they are abusing when altering the MOA of a narcotic pain pill, but still, I cant foresee a label of the bottle stating "by penalty of law, thou shalt not use the spoon or straw". Law and court systems are already increasingly harder to understand. The cat is out of the bag, whether its petting the cat (pleasant) or getting scratched by it (not so pleasant). Each case you might have some down-the-road repercussions. If you pet it, it might need you to take care if it. If you get scratched, you might have to find a way to avoid it or get rid of it. If the cat was still in the bag, no one would have to worry about either.

So what the hell about this cat thing again? I think I am saying as one thoughtful option, they should never have released such a powerful drug that could easily be abused. We are talking about a med that is far stronger than most Heroin. Think about that for a moment. It was just too easy to abuse and oh so sweet if you were at risk to abuse opiates. THEN after several YEARS on the market, you abruptly stop making it in any way which resembled its former self (a completely different drug to many folks) and expect to be applauded for coming up with a clever way to no longer get the full potency of the drug. Meanwhile, many well meaning but addicted people get blindsided without much input from anyone except high earners in suits and politicians who don't know anything about the mental side of withdrawal, chronic pain, and survival as an addict (but still trying to be a decent person or run a family or keep a job...etc). All of these decisions and flip flopping a medication's formula around without much motivation other than $$$. I don't have the answers but I do know and believe these next two statements to be a true. 1. Opana should have never been released with its potency in an abusable form except for use within hospitals or monitored hospice care.
2. Since it was released, the formula should have not been changed without some sort of safety net.

Again, this damn thing is so complex, I really don't know what should be done now. One way to start might be that Endo pay for addiction treatment of willing users who were put on the drug when it first came out. I know that sounds like making gun makers paying victims of gun crimes or even obversely paying to defend the gun crimes in court. Its not the same, addiction and substance abuse is at work here. The truth is that Endo put on the open market a super narcotic and are expecting to clean it up by making people suffer even more by changing the formula. This looks good to officials but man, they did not think this thing through. Any doctor or dentist could prescribe it and no one was educated, not the doctors, not the potential users. Too late now. Damage done and keeps on coming. Kinda like taking Sadam out of power..... must weigh and consider all possibilities, and keeping going in and trying to fix your original muffs are making it worse.

Happy New Year.

 

[Felonious Monk]

I'm saying I'm pretty sure it's a fact, to snort your pills is technically a crime, even if it's impossible to police. Therefore, selling pills which are not very effective when taken as prescribed (at least compared to other already available medications) does not make sense. I'm just kinda surprised nobody has ever made that argument, that we simply don't need oxymorphone tablets for legitimate purposes (injectable liquid being another matter obviously).