The Orange Devil Pill is being removed from market

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The Orange Devil Pill is being removed from market

Postby Zippy » Fri Nov 09, 2012 3:31 pm

Hi.

I just went to Suboxone.com to read what side effects they list for the poison. A big window pops up to let me know that I will not be able to get the pill form. :think:

If you are currently on SUBOXONE® (buprenorphine and naloxone) sublingual tablet (CIII) treatment, it's important for you to know that within the next six months, or possibly sooner, the tablet form will be discontinued. However, you will be able to receive a prescription for the product with the same active ingredient in a different form: SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII).

The decision to take SUBOXONE Tablets off the market was a voluntary choice made by Reckitt Benckiser Pharmaceuticals Inc. as a result of recent information the company received showing higher rates of accidental pediatric exposure (when a child accidentally takes the medicine) linked with the tablet form.

It is unclear, "in the next 6 months" from what date? :shrug:
Cheers,
Zippy

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Re: The Orange Devil Pill is being removed from market

Postby Justjules13 » Fri Nov 09, 2012 5:28 pm

It's a ploy by RB to extend their patent. Greedy fucks....see the blog below..
Last edited by Justjules13 on Fri Nov 09, 2012 5:57 pm, edited 1 time in total.
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Re: The Orange Devil Pill is being removed from market

Postby Justjules13 » Fri Nov 09, 2012 5:56 pm

Suboxone Talk Zone: A Suboxone Blog
Questions and Answers about Opioid Dependence and Buprenorphine
Reckitt Benckiser is Smarter Than I Thought
by J T JUNIG on OCTOBER 14, 2012


Regarding a prior post, I carefully read through the entire Citizens Petition’ filed with the FDA by Reckitt-Benckiser.  I have a better understanding of what, exactly, was accomplished by that action by the manufacturer of Suboxone.

The document explains that the company hired an independent group, RADARS (Researched Abuse, Diversion, and Addiction-Related Surveillance), to investigate the exposure of small children to Suboxone tabs and Suboxone Film.  The results are spelled out in detail in the Citizens Petition.

They show an increase in exposure to Suboxone Tabs over the past ten years.  They also show an increased rate of exposure, i.e. number of exposures, divided by the number of tabs prescribed.  Reckitt-Benckiser wrote that they instituted REMS over the past few years to counter that increase. What are REMS, you ask?

From the FDA site:  ’The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks.’

To meet that requirement, RB claims that they instructed their sales force to be double, extra-especially careful to tell doctors to remind patients to avoid giving Suboxone tablets to their children.  No, I’m not making this stuff up… although the ‘double, extra-especially’ part is my own hyperbole.  I don’t remember exactly how it was worded in the petition.

RB wrote that the warning is actually part of their mitigation strategy—that they expect an impact on pediatric exposure, if their salespeople tell doctors to tell patients to keep the pills out of the hands of children.  Gosh—good thing they did that!  I’m picturing all those people who having their 2-year-old kids managing their Suboxone!

But telling doctors to tell patients this ridiculous bit of information did not solve the problem, so RB claims they needed to do more.  They decided that every dose of Suboxone must be individually packaged.  But they had problems with the stability of naloxone while producing individually-packaged Suboxone Tabs, leading them to make the Film form of the drug.



To read the petition, the expiration of their patent on the tabs had nothing to do with anything.  And the long, new patent on the Film has nothing to do with anything.

I have a couple questions at this point.  First, the obvious one—did RB REALLY have a discussion about having their salespeople remind doctors to remind patients to protect their children?  Do they really think that patients and doctors are that stupid—that their salespeople can make a difference in that regard?

Second, do they really find it necessary to individually wrap each dose of Suboxone, a combination of an opioid partial agonist plus an opioid antagonist, when oxycodone, hydromorphone, hydrocodone, and other potent opioid agonists are sold by the bottle?  I could go on and on about this issue… most patients on Suboxone guard each tablet carefully, as they are prescribed to match up with the number of days in each month… whereas opioid agonists are usually prescribed to take ‘as needed’, meaning the tabs are much more likely to end up in kitchen cupboards or otherwise unaccounted for.

Why would a company hire another company to find fault with their product?  One might think that the manufacturer of a substance would be, if anything, pointing out the safety of their product—not arguing that it is unsafe.  This is where cynicism starts to set in; where I wonoder if they are really just ‘Here to Help.’ I’m supposed to believe that RB discovered a problem with their product, hired a company to assess that problem, and then voluntarily withdrew the product from the market.

To believe the RB line, I have to accept a number of coincidences.  They wrung profits out of the tabs for almost ten years, and just happened to figure out this danger within a year after patent expiration—just when generic pharmaceutical companies were able to manufacture cheaper forms of buprenorphine.  The company has been dreading the flow of generics for years;  heck, their reps spend more time talking about THAT issue than they do about pediatric exposures!  It is also an odd coincidence that RB just happened to be pushing the Film like crazy to insurers and Medicaid agencies, well before their ‘discovery’ of the danger of pediatric exposure to tablets.

To really understand the situation, you must read all the way to the top of page 29 of the Citizens Petition.  There, the attorneys for RB point out to the FDA that if a manufacturer voluntarily withdraws a medication for safety reasons, the FDA is not allowed to approve any new drug application for a generic that is based on the withdrawn medication.

Wow.  They have some darn good attorneys at RB.



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Tagged as: citizens petition, generic buprenorphine, generic suboxone, Reckitt-Benckiser
Even if you fall on your face, you're still moving forward.
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Pills and IV Morphine- 1985-1999
Methadone maintenance- 1999-May 23,2011 (140mg, tapering to 10 mg)
Suboxone-slow taper to zero, very minimal WD (jump date 12/9/14)
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Re: The Orange Devil Pill is being removed from market

Postby Zippy » Fri Nov 09, 2012 6:12 pm

I have an appointment with a prescriber on Tuesday. I will have dozens of questions.
Cheers,
Zippy

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Re: The Orange Devil Pill is being removed from market

Postby Mrblazed » Tue Nov 20, 2012 4:09 pm

If need be you have to take bio just stick to subutex idont see why anyone would have a problem getting subutex I have had doctors that raise a eyebrow intill I say that it gives mr withdrawl like symptoms really just give me a narly headache but if you say I devolped a naloxone intolerence(which is what my old Asa sub doc called it wheb I told her suboxone was causing this, it wasn't intill I got subutex gen. I four out how much cheaper and better of a med the suboxone. I hear some people say it's worse to come off suboxone then subutex due to the naloxone, but I hvent found this true. But I would rather not get sub cut with some nasty anti abuse/OD med. Sorry RB you're hand has been out of my pocket for years now. Now if only I could stop paying teva And roxane so much cash. I think they make ever narc on the planet. So far I have got a few strong genrics from uppers to downers. Intersting they make every common narc used I think they are all pretty bad but Rb can take solid shit abd turn it into hold who ever was te backbone of their marketing, logistics, and law. Because they are some evil guinesses ove there at RB the sub strips I have got them once and was very nail on the suboxone coffin.
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Re: The Orange Devil Pill is being removed from market

Postby ratch » Sun Dec 09, 2012 5:42 pm

As soon as the patent expires for the film in 6 more years they will "introduce" a new patch or gum to keep the profits rolling. People can still get the orange slime generically if they want..but Reckitt wants you to keep those dollars in their own pockets.
From the beginning in was Buprenex (where I got my start)
then Suboxone in 2004/05, then "magically" 7 years later in turned into films...
Cant wait to see how they sucker more fools onto this shit in 2018
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