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PostPosted: Wed Dec 28, 2011 8:42 pm 
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So, I just found out that Reckitt Benckiser Pharmaceuticals Inc is discontinuing subutex starting January 1, 2012, in order to prevent "diversion and misuse" since the Subutex does not have NALOXONE. This is absolutely RIDICULOUS!!!!!!!

First of all, I am on the generic Subutex from Roxanne, so I am not affected, but two things:

(1) First of all, misuse and diversion of Subutex is not that big of a problem, right? Not nearly as much so as full opiate agonists. Second of all, the nalaxone is ONLY active if it is injected AND you are dependent on a full opiate agonist at the same time. In order words, I would have to be actively taking, say, oxycontin, and then inject Suboxone for the naloxone to make me sick.

(2) I am deeply afraid. In my experience, when one person starts doing something, others soon follow suit. What if Roxanne makes the same decision? I was on regular Suboxone for almost two years before I started generic Subutex. All I had was a discount card and it was so, so expensive. Since switching to the generic form of Subutex, I save almost 400 dollars A MONTH. It allowed me to continue to take the life-saving medication I probably otherwise would have had to be off by now.

I just *pray* that if and when I am forced to switch to the strips or back to Suboxone I have insurance. I guess with the new health insurance law, that will for sure happen by 2014. But then again, who knows, maybe Suboxone won't even be covered under the new law.

First doctors can prescribe only a certain amount of patients, then they pull this crap. There must be some other reason why Reckit is doing this; they must know that the naloxone really does not prevent abuse (except other than maybe by scare tactic). Maybe they are being paid off (i usually am not one to think things like that). I don't know; I am just so pissed right now. Even though I am not being affected by this, it scares me, pisses me off, and shows me things don't seem to be getting any better for the treatment of us addicts with this life-saving drug.

Sorry for my rant.


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PostPosted: Wed Dec 28, 2011 8:47 pm 
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oh, and here is the link if anyone cares.

http://buprenorphine.samhsa.gov/Subutex ... -16-11.pdf


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PostPosted: Wed Dec 28, 2011 10:01 pm 
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Yeah it sucks! We have another thread about this. I think they are discontinuing it because their strip campaign was so effective that it's hardly being prescribed, therefore they aren't making a big enough profit off it anymore. When Subutex is prescribed most patients opt for the generic since it's much cheaper.

At least I hope that's the reason. I too am on generic subutex and it saves me a ton too, I also pay cash. I feel better on the generic and I definately don't want to be paying for Sub again.


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PostPosted: Thu Dec 29, 2011 5:06 pm 
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Actually the misuse of subutex is very high right niw.

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PostPosted: Thu Dec 29, 2011 5:57 pm 
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Bboy42287 wrote:
Actually the misuse of subutex is very high right niw.


What do you mean, Bboy? Do you mean it's being misused more now than suboxone is or just more than usual (whatever that may be)?

Do you have an article or study to share about increased misuse of subutex?

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PostPosted: Thu Dec 29, 2011 6:28 pm 
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That really really sucks................
So Im just wondering how long it will be until the rest follow, and discontinue the generic 'bupe' altogether....
My doc let me take it for about a month, then he got all ''wierd'' about it, saying that they were trying to get rid of it. that was right before I got the patient assistance thru RB.
I guess now he knew what he was talking about.

they really need to make this drug more affordable....its so unfair that dillaud (i know the spellings bad) or morphine is 25% of the cost of suboxone......

Hopefully they DONT disconue 'use' of the generics

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 Post subject: conspiracy theory
PostPosted: Fri Dec 30, 2011 4:22 pm 
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R-B is leading the public, Drs., AND patients on the whole naloxone effectiveness deal...maybe they're hiding or scewing some studies.....someone should file a law-suit...investigate studies they report to FDA *honestly, I don't take suboxone and don't know what i'm talking about but it sounds like a good idea

maybe this is why JJ posted "urgent request" thread.............


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 Post subject: Re: conspiracy theory
PostPosted: Wed Jan 04, 2012 1:39 pm 
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indigochild wrote:
R-B is leading the public, Drs., AND patients on the whole naloxone effectiveness deal


I've been following this story like a dog after a bone and agree 110%. It seems evident that RB is pushing the "naloxone factor," to exert complete control over the buprenorphine market. The timing between RB's introduction of Suboxone film and their patent expiration is neither coincidence nor surprising. Bloomberg Businessweek gives an uncomfortable analysis from a marketing perspective -

Reckitt Benckiser Kicks Heroin Tablet Habit With Film: Retail

I doubt RB has skewed the results of any studies; buprenorphine's efficacy has been proven for years. But when the National Institute of Drug Abuse identifies brand-name Suboxone, rather than buprenorphine, as key factor in its "landmark" study, something seems awry.

Painkiller abuse treated by sustained buprenorphine/naloxone

Most disturbing is the language in RB's letter to health providers regarding discontinuation of Subutex: "...while other mono product may be available on the market, we are concentrating our efforts around less abusable products in order to protect patients, communities and access to treatment."

Not only has RB suddenly realized it's OWN drug is unsafe (what an epiphany!), but not-so-subtly hints that doctors who prescribe product from OTHER COMPANIES are putting the (insured) community at risk...and their own careers.

Reckitt Benckiser is a private corporation, not a government agency, and their tactic reek of coercive monopoly.

Seriously, is this legal?


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PostPosted: Wed Jan 04, 2012 10:37 pm 
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If anyone has the time / inclination, there's a really interesting collection of studies & information about Suboxone Film here:

http://www.tga.gov.au/pdf/auspar/auspar-suboxone.pdf/

RB is referred to as the sponsor

Some of my fave bits:

Quote:
Study CR92/111 involved the administration of sublingual buprenorphine solution at
a dose of 4 mg then 8 mg daily to opioid-dependent subjects until Day 8. This was
followed by “challenges” on Days 9, 10 and 11, in which subjects received, in random
order, single doses of buprenorphine 8 mg + placebo, buprenorphine 8 mg + naloxone
4 mg and buprenorphine 8 mg + naloxone 8 mg, each given as a sublingual solution.
On Day 12, subjects received a single intravenous dose of buprenorphine 8 mg +
naloxone 4 mg. Withdrawal symptoms were assessed using a subject-rated 21-item
questionnaire, a subject-rated visual analogue scale (VAS), and an observer-rated
VAS. The investigators found no significant difference between the sublingual
treatments and the intravenous challenge for any of the withdrawal measures. In
summary, this study does not support the sponsor’s claim. On the contrary, it indicates
that subjects who regularly take Suboxone will not experience significant withdrawal
if they inject their usual dose (suggesting that the presence of naloxone in the product
is not a deterrent to patients injecting their own medication). The study provides no
information as to whether the naloxone content of Suboxone will produce withdrawal
if injected by users who are dependent on other opioids.


This kinda mirrors my experiences. Suboxone did induce a LOT more precipitated withdrawal in me when I IV'd it while I had a heroin habit... Subutex I could IV literally the next day and be OK. But people still seem able to inject Suboxone if that's all they're using, which goes against RB's claims.

This means Suboxone still has some benefits over Subutex, because so many people who IV buprenorphine are also abusing agonists. But is it worth the risk of people being exposed to potential risk of naloxone?

Quote:
The claimed benefits of the soluble film need to be weighed carefully against its clear
disadvantages and against the risk/benefit profile of the currently available sublingual tablet.
Naloxone is extremely unstable in the soluble film formulation, degrading rapidly to a large
individual impurity or a given impurity profile at the level(s) specified. The
number and high levels of impurities, whereas naloxone is relatively stable in the sublingual
tablet. As naloxone is present only as an abuse deterrent, compliant patients taking the soluble
film would be exposed to unnecessary additional risks with no concomitant benefit.


Quote:
The sponsor has argued that because each soluble film is packaged individually in a child-
resistant laminate sachet, this should reduce the risk of unintended exposure in children
compared to Suboxone tablets (although only where the patient is allowed to take a
supply of the medication home for self-administration). However, if it is truly the case
that the child resistance of the current sublingual tablet packaging is inferior to that of the
proposed soluble film packaging, then this is an argument for improving the tablet
packaging, rather than a valid rationale for registering an entirely new formulation.


I was talking to a couple of doctors over Xmas. They said the real problem isn't so much a skewing of data in studies. Moreso it's that negative findings of any pharmaceutical seem to not be published in journals anywhere near as much. Most drug studies have funding from their manufacturer, which isn't bad as studies really rely on that money. But it means companies can also influence which parts of their drug get studied. In the case of Suboxone, there seems to only be one study revealing the fact Suboxone can be injected easily, yet so many studies showing it induces more withdrawal in active heroin addicts. So when a journal sees so many studies pointing one direction, and only one pointing the other, they seem to go with the herd.


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PostPosted: Thu Jan 05, 2012 6:58 pm 
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I would LOVE to go over those studies in depth and have already gathered a folder of the EXACT type of information - Tear, thanks SO much for posting the Australian study! If anyone else had problems accessing the hyperlink, I think it's because of a tiny typo at the end. This should work:

Australian Public Assessment Report for Buprenorphine/Naloxone

After getting sick and tired of RB's antics (literally, "sick and tired"...while trying to get a prescription refilled!), I brought these issues up to various friends and was urged to "put the story" on paper. Right now, I'm gathering as many supporting documents as possible, as well as attempting to write a bare bones story of Suboxone, from the drug's inception to the present. While most of the story is available on the internet, there's one thing I can't figure out -

Buprenorphine was originally intended as an analgesic. When and how did it make the leap from pain-killer to opioid replacement?

From a public health perspective, I'm still pondering the legality of RB's letter to doctors and it's lasting repercussion on low-income patients. Pharmaceutical companies have historically taken extreme measures to encourage prescribing of their product (think exotic cruises for doctors). But RB's discontinuation letter, in my opinion, goes beyond promotion to intimidation.

Of course, I'm a writer, not a lawyer. But does anyone have any legal knowledge on this subject?


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