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Opana Oxymorphone ER HCl Tablets Now Approved by the FDAMarketWatch article - June 23, 2006 Endo Pharma jumps on FDA approvals "This is a major milestone for Endo, as it's our first in-house NDA [new drug application]," said Endo Chief Executive Officer Peter Lankau, in an interview with MarketWatch on Friday. "It will help us diversify our portfolio." Lankau said that although his company is not projecting peak sales for the new Opana formulations, sales of long-acting morphine products peaked as high as $300 million a year. Lankau added that Opana's competitors would be such narcotic pain relievers as Duragesic; Oxycontin, known generically as oxycodone; and long-acting morphine. Lankau said that Endo will enjoy three-year market exclusivity on the new Opana products. The company also plans to re-brand an injected form of the drug for hospital use, he said. Endo also issued a new financial forecast, stating it now sees 2006 sales coming in between $880 million and $910 million, with combined sales of the new Opana formulations amounting to between $20 million and $30 million. ( categories: New Medicines )
 wow! that is awesome. it
wow! that is awesome. it will be very interesting to see how it plays out and unfolds over the next few months. i am probably blind and the information is in their but did you by any chance catch when it would be available at the pharmacies? at any rate thank you for the interesting fresh reading:)  Opana
Da Purdue Pharm, thanks for letting us know about the Opana approvals. Phisher, according to Endo Pharmaceuticals Inc. press release dated June 23, 2006, Opana and Opana ER "...are expected to be commercially available in the U.S. in the coming weeks." And here are the pill ID imprint codes for the two Opana products: Pill Identification - OPANA Immediate Release
Pill Identification - OPANA ER Extended Release
I'm
not a pharmacist or a medical doctor. This message is not medical
advice nor is it an offer to provide medical advice. All drug
identifications should be validated by a licensed MD or pharmacist. Endo announced on July 24th
Endo announced on July 24th that they had "begun shipments to its customers and is instituting a wholesale and retail stocking program to ensure these products are distributed to retail pharmacies across the U.S. over the next several weeks" This came from a 'commercial availability anouncement' from Endo. That was four days ago, so it should be pretty quick. Time to recoup research and development costs.  Opana ER
Thanks for continuing the research on this new approval for pain sufferers. Opana ER should have a great impact and help many patients who have not found relief with other pain medications. Who ever can please post a pic if any are available for upload this would be much appreciated thanks to all :P
My comments are my opinions based on the questions posted on this message board and should be taken purely as is and not as medical gospal. Please consult medical concerns with medical proffesionals. Thank You! Opana out...
Opana just became available here, only 1 pharm stocks it. Posted pic of the 10mg ER, I'll post the 20 and 40 when I get them. http://www.pharmer.org/node/5117 Got some pictures of the 5mg ir
i havent seen any studies to
i havent seen any studies to suggest otherwise. so i would say yes. all thoughts and opinions expressed are those of my own and should not be mistaken for medical advice. i am not a doctor nor a pharmacist. all medical questions should be answered by a licensed pharmacist, doctor, or primary care manager.  I agree, CII
I agree with Phisher. Since this med is scheduled as CII, I think it's pretty safe to bet that it comes with the same abuse potential as the rest of the opiates. I just hope this drug doesn't end up like Palladone. Seems like everytime there is a new drug out that proves to be useful, a group of degenerates find a way to abuse it. From reading a couple of chronic pain support groups sites, this drug appears to be a Godsend. Now, if people will just be able not to abuse it. gtrplayer Oh come on, someone NOT
Oh come on, someone NOT abuse an opiate drug? Impossible. That's like setting a $100 in the middle of Times Square on New Year's eve and posting a sign to please not move the bill. LOL Drug abuse seems to be as American as Sex,Drugs, and Rock-n-Roll. Sorry, but until someone makes it unattractive to abuse drugs, people will.
Two part post.Part I) Just a
Two part post. Part I) Just a reminder of what Schedule II means: From Wikipedia "(A) The drug or other substance has a high potential for abuse. (B) The drug or other substance has a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions. (C) Abuse of the drug or other substances may lead to severe psychological or physical dependence."
Part II) From what I understand about Palladone is that it wasn't necessarily the abuse potential that got it removed, but rather a fundamental design flaw. Before I start an argument please read post in its entirety: I know the flaw was that; when mixed with alcohol the drug was released all at once. From the FDA "Pharmacokinetic data indicate that the co-ingestion of Palladone and alcohol results in dangerous increases in the peak plasma concentrations of hydromorphone. These elevated levels may be lethal, even in opioid tolerant patients." I agree 100% that consuming large amounts of alcohol and certain meds simultaneously, is abuse (needless to say, not smart). I personally believe that it is should not necessarily be considered abuse if the alcohol is in extreme moderation (ex. a pain patient has a glass of wine with dinner). After all, most warning labels don't tell the patient to abstain, rather the monograph says something to the effect of 'speak with your doctor before you consume alcohol while on this med'. Some drugs carry stronger warnings pertaining to alcohol than others, I am aware of this.
But from what I understand, Palladone would release all (or most) of the Hydromorphone if even a small amount of alcohol was ingested (such as the example above). From the Washington Post "All powerful pain-management drugs have serious risks if used incorrectly, but the current formulation of Palladone presents an unacceptably high level of patient risk," said Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research. "Although we have not received reports of serious problems, this product has so far been used in a relatively small number of patients. We are concerned that as more patients take this drug, safety problems will arise since even having one alcoholic drink could have fatal implications," Galson said in a statement. The label for Palladone already includes a standard warning against the use of alcohol with opioid (morphine-based) drugs. The agency said "the FDA does not believe that the risk of serious, and potentially fatal, adverse events can be effectively managed by label warnings alone and a risk management plan."
Purdue seems to be working on the problem. Purdue President, Michael Friedman, said the company plans to reformulate the drug and reintroduce it as soon as possible. But whether or not we will ever see this drug on the market again in the US, has yet to be seen.
A European version of this drug made by Napp, called Palladone-SR, is still available on the UK market. Their 'Palladone' seems to be immediate release hydromorphone available in 1.3mg and 2.6mg capsules. But their 'Palladone-SR' is extended release hydromorphone available in 2,4,8,16 and 24mg capsules. I do not know if the European version has the same release problem when mixed with alcohol that the US version did. that is the only reason i
that is the only reason i ever heard. i was unaware that people were under the impression that it was removed for abuse reasons. all thoughts and opinions expressed are those of my own and should not be mistaken for medical advice. i am not a doctor nor a pharmacist. all medical questions should be answered by a licensed pharmacist, doctor, or primary care manager. ahh, i forgot about that
thanks for that post Incognito. I completely forgot about the alcohol interaction. I jus assumed it was kind of understood not to mix narcotics with alcohol, but this just goes to show. I have read that Palladone was a godsend for those in extreme chronic pain, but thankfully have not had to experience it myself. Thanks for the informative post. gtrplaye Good post
"thanks for that post Incognito" I second that comment. I thought Palladone was discontinued because of the potential risk with alcohol, not because it was a faulty design. Reckoned the pharmco didn't want to risk any future problems and stopped the pills before problems might occur. Pharmco probably didn't want to be criticized incessantly by the media like Oxycontin has been harped about over and over. So thanks for explaining the real reason to us. I am really excited about
I am really excited about this new med. It has the potential to make life bareable if not enjoyaable for people with severe and/or chronic pain. Oxymorphone seems like it might be more effective that oxycodone. I think before they only had it in suppository form, my guess is that it has a high potential for abuse so hopefully stupid people don't screw this one up. Like they did for the timed release, high dose hydromorphone. My guess is that it will contain some kind of abuse deterants like gelling agents. I'm pretty sure they will use them, they have to cover their butts from the idiots that will try to commit suicide with their ignorance. I can't belive how many people don't know about all the stuff thats in them to create a timed release (waxes and stuff). I eagerly await to try this new med (pending a licensed professional's prescription of course).  Question
I wonder how this drug would compare to methadone?? Since I have been taking methadone for chronic pain it has given more relief than anything else however if there was something stronger that I could use (obviously under the care of a Dr) I would like to bring that up to my Dr as a possible option. As always I realize that I will never be completely pain free but if I could reach over 60% of the pain being gone I could live such a more normal life. So I guess the question is-----> How does this compare to Methadone? Danielle I think that mg for mg
I think that mg for mg oxymorphone is a lot stronger than methadone. I'm no expert, I could be wrong but I think that 5mg of oxymorphone would be more potent (at least double maybe even triple or quadruple) than a "Methadose 10" which I believe is a 10mg methadone pill. Oxycontin abuse not really what it seemed
It has now been proven that the 1st oxycontin stories started with one lone sheriff who exaggerated it's abuse, probably to get more drug abuse money for their area. Then the story was picked up & printed almost word for word from other sheriffs & law inforcement people & I think it was Time Mag that ran a cover story about the "scare." Well, of course, when drug addicts heard it was so great they THEN went after it in droves. The sad fact is that at the very bottom of some articles (after people had usually already stopped reading) they would write that it was a great thing for people who were truly in chronic pain, but no one seemed to pay attention to that part of the story, only the headline was important. I hate to say it but, I'll bet the media go after this one almost as fast. FDA Approval
If the FDA has approved this new medicine Opana...then it must be safer, or at least have way less of a potential of fatality, after the episodes with Palladone, etc. That is, unless the FDA managed to entirely overlook this, even though we are dealing with two counterparts here: Hydromorphone and Oxymorphone. The FDA would have to ask, what happened with extended release hydromorphone? "Endo said this is the first time an oxymorphone product will be available in an orally-administered, extended-release formulation." My guess, not based on fact, is that companies have tried to release an oral oxymorphone product, but could not get past the FDA, and my second guess is that the Palladone incidents contributed heavily to this. If anyone can prove me wrong and/or back me up with facts? Another point is that...any opiate has the potential for abuse and fatality. Even hydrocodone still causes respiratory depression and slows your heart rate, so if you combine it with the wrong substances, there is still potential for death. Of course, with more powerful opiates (especially more potent by mg) the death potential increases. I think extended release pills have a higher potential because if the extended release mechanisms are interfered with...you are releasing all of the substance instantly...and you better hope that isn't enough to make you overdose. My guess as to one reason why OC 160's were discontinued. I think Palladone of all milligrams was discontinued possibly because people underestimated how potent Hydromorphone was (12 mg doesn't sound like a lot, but that amount instantly released is an overdose in a person without opiate tolerance). What primarily resulted in deaths, as mentioned, was the combination of alcohol...which is bad enough already...but that converted extended release Palladone into instant release Hydromorphone on top of all that. The physician and the pill bottle will warn people not to combine Oxymorphone with alcohol. But once it makes it to the streets...someone will be stupid enough to drink alcohol with it...and probably die...especially if they're dealing with the 20 or 40 mg extended release tablets. As I have mentioned...maybe these tablets are safer, since they gained approval by the FDA. I don't think anything you can put in a pill can counteract the dangers of mixing with alcohol...I guess we'll find out.  opana is just a new
opana is just a new formulation of an old drug called numorphan which used to come in blue 10mg ir tabs. taken orally this drug is really a waste as most of it is destroyed in the first pass. however a 40mg tablet that was abused by releasing all of the drug at once would likely result in death in all but the most tolerant people. Opana is Oxymorphone,
Opana is Oxymorphone, available in instant and extended release formulations. It's roughly twice the strength of Oxycontin. Here are two links to help you distinguish the differences between Opana and Suboxone
Gtrplayer  Oxymorphone come-back
Until its removal from the United States market in the early 1970s, oxymorphone in the form of Numorphan 10 mg instant-release tablets was one of the most sought-after and well-regarded opioids of the IV drug using community. Known popularly as "blues" for their light blue color, the tablets contained very few insoluble binders — making them easy to inject — and were extremely potent when used intravenously. "Blues" were also considered to be especially euphoric; comparable to or better than heroin. Numorphan tablets, and the oxymorphone they contained, are the "blues" referred to in the film Drugstore Cowboy. Oxymorphone is not a component of "T's and blues", 1980s slang for a combination of pentazocine ("T's") and pyribenzamine ("blues"). Excerpt from Wikipedia, The Free Encyclopedia  Opana
Due to chronic back pain I was looking for an alternative pain medicine to switch back and forth every few months. Currently Oxycontin 20mg and Roxicet 15mg (basically a 15mg Immediate release oxycodone) I did some research and thought I would give the Opana ER and Opana a try. Now if you use their conversion 20mg of Oxy would be 10mg Opana well for me I'm glad my physician said no and to use the 20mg Opana..Well for me this medicine either in IR , or ER formula is worthless. It doesn't compare to the Oxycontin...I am refering to the drugs ability to lessen back pain....and for me I'm glad I got small quantity. It seems I read something about the oral solubility and breakdown of this med...Well it may just be me, but if its not I would like to know if anyone else has used Opana for pain and were dissapointed...YMMV (edited by TeamPharmer) Opana vs. Oxycontin
All the rave over Opana for chronic pain has nothing over oxycontin, in my opinion it has nothing over oxycontin for chronic back for that matter any chronic pain, I was on Numorphan in the late 60's-1970 which is suppose to be the same as Opana, but was blaclisted in the early 70's because of drug addict diversion, That form of the medication was great for chronic pain back then experience on Opana
I suffer from chronic back pain with L4-L5, L5-S1 herniation and I was put on the opana 5mg ER, and to me this medicine does not work what so ever. I am not sure if it is just me but Oxycodone works better to me than this medication. My insurance doesn't even cover it and was told it was one of the best meds out here for my condition, well I waisted a good chunk of money. This just may be me, but my experience with being on this medicine is not efficient at all for my back, and I had no side affects either. Might work for most, but for me just another medication proven to waist my money and another day of dealing with pain.  Not for me
I was on 10 mg Er Opana, and it did help w/pain but not compaired to Oxycontin, well brand oxycontin and not Endo. Endo oxycontin just does not last. Opana made me tired, felt weird in my stomach (just not right) and did last, but did not give you euphoric like oxy does. You cant eat 2 hrs before or 1 hr after you take it. Must have empty stomach. May be good for some people, just not me. Be carefull, dr warned me that even mouthwash alcohol can cause it all to be released at once. I dont know if its true or not though. Also, probably best for last resort because not much else stronger than this. I'm now on OC 20mg w/ Roxi 15mg for rescue.--MUDEBONE-- Quote:Should i direct him to
Quote: Should i direct him to one of these It's not up to you when your friend decides to get help. You might mention your fears and observations, but other than that, there's not a whole lot you can do to get him into a treatment program. gtrplayer  Suggestions
You could, as a friend, express concern, but there isn't a whole lot you can do outside of that. I've found in my psycholigical studies in school, that the ab/user has to want to do something about their use before progress will truly be made. As a person who has been through an addiction crisis, myself, I recall that the extreme worry expressed by close relatives actually frightened me a lot, which kept me in my state of desperation, and in turn, my state of use. If you decide to tell your friend, be gentle. Sometimes, even the best of intentions may result in situations that are unfavoruable. Use discretion, is the least I can advise. [n o t h i n g : e v e r y t h i n g : : r e a l i t y Good read
As a pharmacy employee, I was interested when a patient came in with an Opana RX but unfortunately, didn't do much research. Now that I've got some extra hours on my hands, I'd be interested to read some studies. [n o t h i n g : e v e r y t h i n g : : r e a l i t y Opana and Alcohol
this is a warning for all of those who like to try and give your pain pills a little kick with alcohol. Opana is an extended release pill, which is true, but is also one of most dangerous pills to mix with alcohol. In my studies of this back in 2005-06, I came across a detailed break-down of Opana and it described the use of alcohol with this product and it was very unsettling. Alcohol makes Opana to become metabolized at a 3X normal rate...i.e. it makes more of the oxymorphone hydrochloride to be released into the blood stream. It can and will cause an almost immediate overdose and the supression of the breathing( caused by any overdose with opiates) is almost immediate ( usually within 15 to 30 minutes) and even Nargon( the drug that EMT and Er people give to persons who have overdosed with pretty much any opiates including herion) is not effective enough to reverse the effects of the supression of the lungs. It is an 85% chance that if you drink more than 20 Oz. of alcohol with Opana, if you have a really low or no tolerance, death is almost imminant. Now, having said that, if Opana works for you and if this has made you think twice about continuing your regiment, please don't be too concerned. Just talk with your doctor and be honest with them. I have been in pain management for over ten years now and it is sad to say that I don't see the end anywhere in sight. I have taken several different meds and have tried to make the best of my life even though I have so many problems. When I come across information like what is above, I like to put things up that help others understand and respect what those meds are for and also to show that thru medicinal therapy, we can try to live productive lives despite our afflictions. Please, if there is something ou t there that is new and you feel needs to be put up in forums, please take the time out to do so...you nevr know, you may just save someone from accidentally over-dosing and just might teach us all something new!!! Peace. Love, and Prosper!!! " Even Nargon( the drug
" Even Nargon( the drug that EMT and Er people give to persons who have overdosed with pretty much any opiates including herion) is not effective enough to reverse the effects of the supression of the lungs "
I believe that you mean Naloxone otherwise known as Narcan or Naltrexone otherwise known as Revia  |
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