Tuesday, April 6, 2010

U.S. FDA Approves New OxyContin Formulation

In The NewsThe U.S. Food and Drug Administration (FDA) just approved a new formulation of the popular controlled-release opioid pain reliever OxyContin®. The reformulated version is expected to help discourage misuse and abuse of the medication; although, caution is still needed by prescribers and patients.

Approved by the FDA in 1995 and manufactured by Purdue Pharma L.P., Stamford, CT, USA, the active ingredient in OxyContin is oxycodone, which slowly releases to treat patients who require around-the-clock medical management of moderate to severe pain with an opioid analgesic. Persons intent on abusing the previous formulation were able to release high levels of oxycodone all at once, contributing to high rates of abuse and potentially fatal overdose. There also were reports of inadvertent overdose with OxyContin after healthcare practitioners crushed the drug for administration to patients who could not swallow the tablet.

The reformulated version is intended to prevent immediate access to the full dose of oxycodone via cutting, chewing, or breaking the tablet. Furthermore, attempts to dissolve the tablets in liquid result in a gummy substance that cannot be drawn up into a syringe or injected. However, if administered in higher than recommended doses, the new formulation can still be abused or misused and result in overdose, so healthcare professionals need to remind their patients of the risks associated with using OxyContin not-as-directed. “Although this new formulation of OxyContin may provide only an incremental advantage over the current version of the drug, it is still a step in the right direction,” said Bob Rappaport, MD, of the FDA.

The FDA is requiring an “interim” REMS (Risk Evaluation and Mitigation Strategy) for this product that will include a Medication Guide for patients and required prescriber education regarding the appropriate use of opioid analgesics in the treatment of pain. Purdue also is required to conduct a postmarket study to collect data on the extent to which the new formulation reduces abuse and misuse of this opioid.

Sources:
> FDA Approves New Formulation for OxyContin [news release]. April 5, 2010 [
available here].
> FDA teleconference; April 6, 2010. Presentation by Bob Rappaport, MD, and staff.
More Information:
> OxyContin - Questions and Answers. April 5, 2010 [
available here].
> A Guide to Safe Use of Pain Medicine. February 23, 2009 [
available here].

16 comments:

Anonymous said...

This is a very good idea as we are seeing more family abuse of patient medications.

Anonymous said...

I don't understand what they mean by reformulation? Are they putting suboxon or something like that in it? They are not being very clear about how they have altered it and when does the new formulation come out?

I just pray it doesn't make the medication less effective. Its the only one I can take without horrid side effects, so I hope, just because some people abuse this medication, that they haven't hurt those of us who take it legitimately and as prescribed.

Anonymous said...

I have even emailed the manufacturer about this as it's the only long acting one I'm not allergic to and finally they did the right thing.
I'm not an abuser; I'm a chronic pain patient and I've remained on the same dose for 9 of 11yrs.
It is about time. I too pray it doesn't take away the effectiveness as the generics were 40% less effective and my doctors told me this.

Anonymous said...

I think this is very bad because for people like me who have a hard time swallowing my medication , I crush them and then sallow my medication. Now because of this new (Reformulation) they are punishing people who dont abuse are meds. I don't think this is very fair if people are going to abuse meds this is not going to stop them, if their going to do it, thier going to do it.

Anonymous said...

I have remained on the same medication at the same dosage for the past 5-6 years. This medication allowed me not only to work full time pain free, but I was able to do things after work at home and with my family that are important too. I have been on the new formulation for almost a month now. In my experience it isn't nearly as effective as the original. I have began limiting my self at work and home, something I have not had to do in so many years. In turn depression is creeping back into my life and my family pays the price. I have to tell my 9 year old that mom can't play ball today....because I can hardly lift my right should or turn my neck. The pain from numerous operations I have had performed on my feet cause me to close my business early (2 or more hours) at least 3 time a week. I have no insurance and by the grace of God a local pharmacy on charges me a small amount over his cost, in return we provide our business services to him at cost. Even so I pay a fortune for the Oxycontin medication, if the generics had worked people would have taken them. I work hard to live a pain free and now I'm not sure what will happen. I can't pay this much money for somthing that doesn't work, I have tried other alternative medications with no luck.
People that abuse these medications will simply go one to another drug, like morphine or herion. It seems to me the only people to suffer will be legit chronic pain patients. I welcome any advice or reccomendations.

Anonymous said...

anom poster from aug 19 states they crush oxycontin and in the same breath claim to not be a drug abuser..if you are crushing oxy CR you are abusing the med period.

Anonymous said...

I too am a chronic pain patient. I have the new oxycontin and it is not as effective. I thought it was my imagination because I din't realize they where the ones. Yep a definite difference. I have to tell my granddaughter that I can't play because of [pain. UGH

Anonymous said...

I also take Oxy for chronic pain and I am finding the new formulation to be MORE effective. I had no breakthrough pain today and did not need to take my "rescue" medication. Weird. I wonder why it affects me that way while other people are finding it to be less effective.

Anonymous said...

Oxycontin is one of the most addictive opiates because of the sustained release. It provides the body with oxycodone for extended periods wherein the body becomes tolerant to its presence much more readily than immediate release. An individual would need to take other immediate release opiates six times/day to have the same effect and build the tolerance required for chemical addiction to form. In that way, it is much harder for someone taking oxycontin (as intended) to stop when compared to a immediate release oxycodone. Purdue wants to prevent abuse, but addicts will always find a way to get high. IV drug users don't care if there is shoe polish in their heroin. Where are the studies showing no affect on chemical dependence. Cigarettes have gone through many formulation changes, at first the lower tar versions were thought to be safer, but later we found out that they had additives that enhanced nicotine or even increased the nicotine content itself making them even more addictive. We are so concerned about the abusers, but we have forgotten the majority of people taking the medication as intended. This new formulation may produce chemical dependence on a scale never seen before. Less abuse, but more regular customers.

Anonymous said...

This new oxycontin recipe is going to cause more harm than good. First, they are what I joke as being "delayed release". The medication lasts a very, very long time, probably a bit longer than normal, which is why some patients give it a thumbs up. The concentration of the drug that gets released, however, is lower than it used to be. A patient can find themselves taking twice as much at a time, just to get similar effects from old oxycontin. This is of course problematic because 1. They could quickly develope a higher tolerance to the drug, if they do find it is neccessary to take more... (and chances are they will), and 2. They will end up running out before it is time for their new prescription, leaving them in a painful position because asking a doctor for more of a narcotic is a sure fire way to get kicked off the stuff. If a patient doesn't take more than usual, they will find that they are in quite some pain. It's a catch 22. As for this being a "good idea" because it will make abusing the drug more difficult, one has got to realize it is not that easy to detere an addict. They are, after all, addicted to opiates. All that an addict will end up doing is taking much more of it at a time, and increase their chance of an overdose. To think that by making it more difficult to abuse will stop people from doing so, is ludacris... remember THEY ARE ADDICTS AND WILL DO WHATEVER IT TAKES TO GET THEIR HIGH. So it can't be crushed or shot up, that doesnt mean they will just give it up and walk away. They will find a way to make it work for them, no matter what. And don't be fooled, Purdue Pharma knows that this is exactly what will happen. It is even more money in the bank for them. They will pay docs to give this to patients, instead of oxycodone, codeine or morphine under the guise that it is less harmful, or less likely to be abused. As I have said before, neither of these points are true, and they will be cashing in on people's pain and suffering, and rob even more food out of the mouth's of familys and children of drug addicts.

SB. Leavitt, MA, PhD said...

In the interest of free speech, we have permitted public posting of the above commentary. However, we would caution readers that it is one person’s opinion and does not reflect scientific or other verifiable evidence regarding actions of the new oxycodone formulation, the nature of addiction, or the motivations of pharmaceutical companies. -- SBL

Anonymous said...

Waaaay less effective!!! I am a CPP and I have been taking this medication (successfully) for almost ten years now. I haven't had to increase my dose in over three years BUT these "new" OP's come out and yeah, now I have to go into my Doc and discuss another alternative. I do not abuse my meds but find that I have to take at LEAST twice my dose for the same effect. Shame on Perdue for changing their formula!!! There always have been and always WILL be opportunistic people out there. Now I have to suffer!! Thanks, Perdue, thanks a million.

Anonymous said...

This drug is something that needs to be monitored much more strictly, almost all of my graduating class used this recreationally, getting it from older adults who were selling the scripts they didnt need. As a nursing student, yes I understand it may help some in the way of living better lives when used correctly but if it means you are saving someone from ruining thier life due to addiction, does taking an extra pill really seem like that big of a deal? Maybe the people who are addicted now will find another way to get high but when I think about the people who may be prevented from beginning to abuse this drug i believe there are only benefits from this change.

Anonymous said...

Dear "Nursing Student," I understand naïveté but being a nursing student you should get this!! Making someone "take an extra pill" will make THEIR tolerance to the medication increase. Come on, really?? Do you REALLY believe that your POTENTIAL, hypothetical, future, maybe, coulda-woulda-shoulda ADDICTS that MIGHT exist wont find something ELSE to take? If you don't then you might want to consider a new career path (or something) that doesn’t require you to actually think, let alone one that requires you to have empathy for someone else. This is only 'punishing' the patients who already take this medication and NOT those who "might." I pray that the nay-sayers that do NOT live in constant pain ever have to experience life like those that live with chronic pain do.. And when a medication that allows one to live life in less pain is altered, then, well, I am sure you can figure it out. Then again, maybe not...

Patrick said...

Also, thank you to all you little BASTARDS who decided to abuse this medication in the first place thereby in the process, effectively have all the doctors unwilling to help, anyway long story but I'd really like to know what you all think. Is it working?

Anonymous said...

I am a CP pt who was changed to OPs in the summer. I actually went thru withdrawal then found taking the meds w food helped. But my pain levels are much higher & more unpredictable than when I was on OCs. IMO this new formula was not tested adequately. It might turn into gel but who cares when it doesn't provide good pain control. Addicts will still find a was to abuse any drug. How is already on the net.