Opana New Formulation Coming Next Week

The new formulation of Opana ER will be coming out the second week of March apparently.

Let's hope it will be more successful than the re-formulation of Oxycontin ER. So many chronic pain patients had to switch off of that medication when they changed it due to reduction in effectiveness (mostly due to the coating not being dissolved enough before it passed out of the body apparently) and stomach problems from the coating as well. I was one myself.

I am not talking about any of those people who abused the drug, but rather the true pain patients who used the drug correctly. It stinks that they have to change these medications around, the ones that are truly helping people who suffer from horrific pain, just because there are people out there abusing them.

I talk to people in pain every day and you hear the same thing over and over; if I didn't have to take pills for this pain, I wouldn't. I take the fewest I can every day just to get by. Once you find something that helps decrease your pain, even a little, you are thrilled and the last thing you want is to have to go hunt for something else.

So, let those of us on Opana ER, hope and pray that the new version works as well as the old version, with no stomach or dissolving problems. After all, we have enough to deal with.

For those of you who abuse these meds ... please get some help and get a new hobby. You are hurting more people than just yourself.

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REPORT

I just went to the Dr on Friday and read the notice that was sent out to the drs, pharmacys, and paitents, there WILL NOT be a new formulation of opana er, as its stated they have known about this problem of the mix up since 2009, and it only happend two times and the pharmacys cought the problem before they were givin to paitents. Go on endo pharmacuticals and read the letters that they sent out to everyone. This is how rumors get started, if you don't know what your talking about than don't say anything at all and start scaring people that are in enough pain as it is, and now you have them stressing out about this. They will be back out in the middle to the end of march, and they will be the same opanas that we have been getting all along!!!!!!!! Please do your research first before posting such nonsense!!!!!!

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I too talked with my pharmacist before I posted this. I have written to Endo Pharmaceuticals directly for a clarification and if they get back to me with different information I will post it here. But the information sent out by the company is quoted in this article as saying

"Endo is committed to executing a seamless transition in 2012 from the original formulation to the new formulation, which utilizes the proprietary INTACâ„¢ technology owned by Grunenthal, a partner in the development of the product. The new formulation will continue to be called Opana ER with the same dosage strengths, color and packaging and similar tablet size and shape. Also, the FDA approval signifies that there is no significant difference in the rate and extent of absorption of the therapeutic ingredient between this new formulation and the original formulation of Opana ER."

And this wasn't back in 2009, this was December , 2011
Endo Announces FDA Approval of a New Formulation of Opana® ER Designed To Be Crush-Resistant

There was also another article I read BEFORE I posted my notice above, again very recent, not from 2009 but from a few weeks ago, February of 2012. It discusses the NEW FORMULATION OF OPANA being released by Endo.

This is FROM Endo!

Crush-Resistant Formulation of Opana ER® Approved by the FDA

February 13, 2012 - In December 2011, the U.S. Food and Drug Administration (FDA) granted approval to Endo Pharmaceuticals for their new, crush-resistant formulation of the long-acting opioid analgesic, Opana ER (extended release oxymorphone). Newark, DE, based Endo developed the new formulation in partnership with Gruenthal. The new formulation, which utilizes the proprietary INTACâ„¢ technology owned by Grunenthal, will continue to be called Opana ER with the same dosage strengths, color and packaging and similar tablet size and shape. Also, the FDA approval means that there is no significant difference in the rate and extent of absorption of the therapeutic ingredient between this new formulation and the original formulation of Opana ER.

Opana ER contains a potent, Schedule II opioid, oxymorphone, indicated for the relief of moderate to severe pain requiring continuous around-the-clock-relief for an extended period of time. It is not meant for use in treating acute pain. The new formulation does not change or remove the risks inherent to opioid analgesics such as abuse, overuse, respiratory depression and sedation. These tablets are meant to be swallowed whole and should not be crushed, chewed or broken as doing so can release a potentially fatal dose of oxymorphone.

There is currently a shortage of the new formulation of Opana ER which is expected to be resolved by the middle of this month.

For more information, please refer to the full prescribing information:

endo.com/pdf/products/Opana%20ER%20PI%2020111212.pdf


THIS ONE COMES FROM ENDO!

Straight from the horses mouth and just a few weeks ago!

Sooooooo, yes, I did my research before I posted the message above. I didn't just make this up, didn't just try to star a rumor. Although I appreciate your very kind remarks and assumption of innocence. There were even more articles available on the net than the two I cited, out there for anyone to read.

If there are any articles saying there are no changes to the opana coming back out this month, PLEASE post them here with the release date. If you have information from Endo that contradicts what Endo itself says in the above statement from them, as you say in your post, please share it.

Research. Check it out.

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I've been taking Opana ER 40mg three times a day since mid-2008. It has always worked pretty well. A few days ago I picked up my month's supply and discovered a mixture of the old and new varieties of the pill (the old ones are octagonal and the new ones are circular). The new ones take noticeably longer to start working and seem to only get up to about half of the previous level of relief, but does seem to last longer and less of a steep drop-off when it stops working. And it does hurt my stomach a little, unlike the previous formulation. I've always liked Opana because I generally don't need medicine for breakthrough pain, but now I don't see how I can get by without breakthrough meds!

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I would just like to know if you feel like as Big of an A$$ as u acted? I do believe you were the one posting BS. Did u dream u read that n ur Docs Office r did u just think.if u wanted it to b so n lied about it that it would make it true??? U should take ur own advice n research something before posting S$!%

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This was meant for Jess257.

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Why is every one whating the opana better high..... Just wondering.. who cares if they change that kind of med ot not....U still getting it..... I have NEVER SEEN SO MUCH WRITING ABOUT DRUGS.....UNREAL......

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I NEVER HAD TO DO ALL THIS OPANA , EXT EXT.... BUT U PPL N PAIN SOME NOT ALL R USEN THIS STUFF RIGHT. SO THOSE PPL THAT NEED PAIM MED NOT OPANA. MEVER SEEN ONE DONT WANT TO JUST B HAPPY THEY GIVE U SOME KIND OF REF... CUZ THEY R AND I KNOW FOR A FACT GONNA B CLOSEN DOWN A LOT OF THE PAIN MAG. DUE TO DRS WRITING WAY TO MUCH MED...U CAN TELL THEM ANYTHING AND GUESS WHAT U HAVE A DEADLY GRUG PROB... SOME R TRUE... TO HAVEN PAIN..... 80% ..IS JUST A FREE HIGH....

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I have no idea what it is you tried to type there.

Can you do it in English please? Complete words? Use spell check if necessary?

Thank you

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I am a nurse and I have cared for many chronic pain sufferers such as paraplegics, cancer pts, neuropathy, you name it, oxycontin was a wonder drug for these people, they took it away, now opana is going, pretty soon it will be roxycodone and dilaudid, its bulls***, I have yet to meet a patient that states they get the same relief, why don't we just take every single pain Med off the market and let people use tylenol and meditation, some people abuse their privilege to drive by drinking and driving, should we put mandatory breathalyzers in all cars? No....that's why we have law enforcement, this whole thing is a joke, punishing everyone because some abusers take it too far, does anyone know if there is a possibility of a generic coming out when the original formulas patent expire? I've heard that it expires in 2013

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Excuse you Donna for me not KNOWING MY INFORMATION CORRECT FOR YOU, MY DR. OR PHARMACY DIDN'T KNOW ANYTHING ABOUT THE NEW FORMULATION AT THAT TIME!!!! IF YOU SEE THE DATE IT WAS WRITTEN MONTHS AGO AND YOU JUST FEEL LIKE ATTACKING ME NOW? SORRY for the MISINFORMATION, but seriously get a life, nobody knew this it was just let out in ct. Recently, and I'm still getting the old formulation!!!!!! So when I do get the new ones you will be the first to know!!!!!!!!

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AND OH YEAH DONNA LAST TIME I CHECKED I WAS HUMAN AND AM INTITILED TO MAKE MISTAKES, I GLAD YOU ARE SO PERFECT, YOU MUST FEEL SO GREAT ABOUT YOURSELF PICKING ON OTHER CHRONIC PAIN PAITENTS!!! YOU REALLY SHOULD GET ANOTHER HOBBY, BECAUSE THIS IS WHAT I WAS TOLD AND WAS ONLY TRYING TO HELP, SO I DON'T KNOW WHAT YOUR PROBLEM IS BUT DON'T SWEAR AT ME I'M A GROWN WOMAN WITH CLASS, AND YOUR PROBABLY ONE OF THESE PAIN PAITENTS SELLING YOUR MEDS!!!! I DON'T APPRECIATE YOU VERY UNKIND WORDS AND LIKE I SAID BEFORE GET A LIFE, HOBBY, OR SOMETHING ELSE, INSTEAD OF BULLYING PPL ON THESE TYPE OF SITES, WE ARE ALL HERE TO HELP EACH OTHER, APPARENTLY YOUR NOT, YOUR JUST HERE TO PUT PPL.DOWN AND BE A BULLY, PROBABLY WHAT YOU HAVE BEEN YOUR WHOLE LIFE!!!!!!!!

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Jess I sincerely apologize I thought u were being ugly in your original post. Anyway, im sincerely sorry I dont sell my meds Im so sick and in so much pain thats probably wgu I was so ugly in my response to u, but thats no excuse. There is no excuse. All i can do is once again say im truly sorry please except my heartfelt apology. And God Help us all if we dont get some relief n soon
The drs believe the damn Drug company when they say the med is exactly the same but it just cant b abused n thats just a LIE. I get zero pain relief n I am sick with headaches cramps gas im irritable as a snake n now to top it all of i am bleeding from my rectum. I have not tried to grind n snort them all ive done is put them n coke n swalliw them. They r worthless and i just cant take it anymore. I really feel for the poor cancer patients. This is DISGUSTING n theres not a thing we can do about it.
im sorry for anyone i offwnded n i am praying for us ALL!

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I just pray all is getting better....

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In the end, for me, the changes they made in Opana simply screwed it up much as the changes they made in OxyContin screwed that up over twenty months ago.

They tried to put a tamper-proof coating on the medication (both of them) and it literally took them mere days to figure out how to get the coating off without destroying the medication. They got rid of the coating and were still able to break down the pills so they could snort and sniff as well as sell the powdered pills, same as before the re-formulation. They were even posting directions on-line!!! In the very same forums that true pain patients were begging the company to not make the changes or to ask others what they could do about the new side effects.

The coating has a tendency to;

1) give people stomach issues
2) make it more difficult to digest the pill
3) keep the pill from being broken down completely before it exits the body

The first two issues are bad enough. The third issue results in the patient being in more pain than ever before, because the pill is not broken down therefore it does not release its' pain relieving properties before it leaves your body. Since it is a time release version, the ER, or extended release, if the new version works for you at all usually it is only for the first half of its' life.

So, once again true pain patients are left out in the cold looking for another source of relief while those who were abusing the system had it figured out pretty quickly.

Did the company make the changes truly to try and thrwart the illegal users or was it because of a soon to expire patent? Who knows and the bottom line for those of us who suffer from horrendous chronic pain, we don't care we just want relief.

Now they have taken two wonderful opiate agonists away; OxyContin and Opana, both in the extended release versions. You can try and get them in the IR versions but they are harder to find and you would have to take a lot. Better to find an alternative opiate agonist.

Do your research , there are others out there. Many have switched to the fentanyl patch. It works pretty well and because it is a patch, goes directly into your bloodstream, no gut issues, or constipation problems. It is one good option.

I was on it years ago, didn't help me much. I decided to give it another try this time though. 25 mg helped a little, we went to 50 mg patch and it has been great for my CRPS.

It isn't for everyone and some people have a problem with the adhesive, it can cause a redness. It does me but doesn't itch so I don't care, takes my pain waaaay down.

We
Hat we can't do is fight with each other. Have patience and realize we are all hurting, speak with care, type with even more care. Be kind to each other.

Peace

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I truly accept your apology Donna, I've heard and googled that in Sept. That there will be a generic form of opana er with the old formula, I belive it is going to be made by Watson PHARM. So everyone hang in there if you can, and hopefully this is true, and Google it like this "will there be a generic form of opana er coming out" and it brought me right to a whole bunch of fda sites and to Watson sites talking about the new generic from Sept 2012- Jan 2013 Than activis will also start carrying it. Hope this helps.

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Watson Pharmacy can launch Generic Opana ER in 2012!

"They settled a patent infringement lawsuit brought by Endo Pharmaceuticals Holdings Inc. and will start selling a generic version of Endo's pain drug Opana ER in September 2012."

You can read the article by going here;
pharmpro.com/News/FeedsAP/2010/10/watson-pharma-can-launch-generic-opana-er-in-2012/

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For some of us that for whatever reason have been saddled with severe chronic pain, this (for me, anyways) has been nothing short of maddening and exhausting. I have cancer, neuropathy and epilepsy. I have been fighting this since day one-12 years now. My story is too long, but the 1st two yrs. I would litterly pass out from pain. After what I felt was folly, 3 hospitals in 3 different states and no help, a pain Doc finally recognized I was not getting pain help and got me on Oxycontin. Life changed that day, it was a miricle drug for me. After formula change, I declined quickly-after 3 months of that garbage. Switched to Opana. New life once again. Now, back to hell.

I wanted to be angry at the pharmacutical company, though why would they want to give up their 'cash-cow'? it is pressure from the gov't. and fda and people that ride the "moral high ground" - but really do not know what they are talking about. They just don't get that if people are abusing it, they will just find something else; they can debate it over six or seven cocktails. I can only speak for myself, but marbles dipped in battery acid cause more pain than they are 'supposed' to take away.

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Sounds like the Opana er is needed other than here :)
Sounds like some stress build up out there from concetrating too hard on dealing with cronic pains. I know because now I might also have Rhumatism along with the DDD/cracks in my spine and the bone spurs/torn cuffs in my shoulders. The supplement my pain managment DR. is giving me, oxycotin er, just isn't doin the j.o.b. I never thought I would be wishing to take a drug...jeese!

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I just happened to stumble on this site. People don't fight with each other. I am one of the oxycotin victims. I agree that the people that want it for a "high" will find a way. And we are left to suffer. I am still on the "new improved oxy's" and in pain. So please, if in fact they do a new formulation, it won't be pretty. God Bless You All!

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Wha?

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Yes...appalling. I suspect home-schooling.

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FYI- More News Endo keeping generic Opana's from being produced.

Lets hear what you have to say about it.

Endo Health (ENDP) Downgraded To 'Sector Perform' By RBC Capital, PT Lowered
October 05, 2012 03:00 PM
Stocks: ENDP, MYL,

(By Balachander) Endo Health Solutions Inc. (NASDAQ:ENDP : 30.4, -0.26) shares were downgraded to "Sector Perform" from "Outperform" by RBC Capital Markets analyst Shibani Malhotra, who cited continued uncertainty around key growth drivers.

The analyst reduced price target on the stock to $35 from $36.

"While it is possible that ENDP may achieve its (above consensus) long-term guidance, this is driven by what we see as somewhat aggressive assumptions made by management around the growth and sustainability of the Opana ER franchise that could yet be derailed by less cumbersome FDA Bioequivalence guidance for generic crush resistant opioids (expected by YE 2012)," Malhotra wrote.

"Additionally, we did not attain enough new information to increase our comfort in the continued long-term growth of the Qualitest generic business (given much of the recent growth was fueled by unsustainable price increases in products that are going away)," the analyst said.

Malhotra believes additional Lidoderm generics are unlikely until 2015 and the analyst sees potential upside to conservative share assumption.

"We understand that Mylan's (MYL : 23.96, -0.13) Lidoderm ANDA uses an acrylic patch and based on comments from Watson during its trial with Endo in March, we believe the FDA will have difficulty approving Mylan's generic."

The analyst said risk to Opana ER franchise remains. "While we do not anticipate generics of the old formulation, Bioequivalence guidelines for the tamper resistant formulation may be less challenging than management currently assumes," Malhotra wrote.

AMS and HealthTronics may be the most attractive strategic assets for Endo, the analyst wrote. "We were particularly intrigued by management's commentary around the use of electronic records to drive patient care, but we need to see strong growth in key AMS segments in the interim."

The stock, which has been trading in the 52-week range of $27.50 to $39.29, dropped 1.68 percent to trade at $30.98 on Friday.

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Endo isn't going to let any company make generic Opana ER's 20mg & up. Everyone needs to switch to something cheaper. They are trying to control our medicines and our money. Everyone who is on the brand Opana needs to have the doctor give them something else. I know Opana did work the best but it doesn't work the best now for the awful pain I have and I know there are others who's pain is worse than mine. There has to be something out there that works just as well that is cheaper. There are thousands of people that take Opana for their pain. Endo wants to keep that big pay off coming from it. The longer they keep other companies from making generic the longer they get the big bucks for it. People who need help need to stand up for themself. I don't know about you all but I don't want to pay the higher prices when I can get something for a lower price. Talk to your doctors.

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Hey everyone, like a lot of people posting here, I am on the reformulated opana er. 30mg 2x daily and was also not getting the relief I thought I'd be getting. I had been prescribed opana once before about a year ago and they hadn't been changed yet and they were great but now they work half as good so I talked to my pharmacist and she said some doctors are telling their patients, if they're willing, to administer them rectally. I'm not the type of person that sticks things up my ass but my nerve damage in my right shoulder and arm from numerous surgeries is unbearable. I decided to try this and for me it works amazingly. it gets absorbed a lot quicker than oral and is finally getting me the relief I've been needing. Hope this helps to all those in chronic pain.

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