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PostPosted: Tue Sep 25, 2012 10:13 pm 
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As of today on chaindrugreview they have discontinued the tablet due to pediatric accidental risks. They will be start removing all tablets from the shelves as of this week and expect all to be removed by the next 6 months. I have taken the tabs but prefer the films but I know that some of you guys and gals still prefer tabs. Just wanted to see what everyone thinks of this. Hope everyone is doing well!!


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PostPosted: Wed Sep 26, 2012 2:15 am 
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I just did a cursory Google search and dammit if you're not right. I found this article out of the UK:

http://www.guardian.co.uk/business/2012 ... sfeed=true

I don't know why it's not being written about more in the US, but oh well.

I'm one of those people who prefer the tablets, but I guess I'll have to adjust to the film. We've talked about how RB has had a major campaign to convince insurance companies, including Medicaid, just how much "safer" the film is than the tablets. They likely want their customers to switch to the film which has the new patent, whereas the tablet's patent has run out.

Thanks so much for finding this and sharing it with us. This doesn't make me happy, but we've gotta roll with the punches. Recovery has taught me that.

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PostPosted: Wed Sep 26, 2012 4:36 am 
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[font=Comic Sans MS]This is actually great news for me! I hate the tablets! And the government wont carry the films. So I am sure they wil be one of the last pharmacies to do the switch, but it's great to know that they will have to! Thank you so much for this information Imgillt1!!![/font]

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 Post subject: Suboxone tabs
PostPosted: Wed Sep 26, 2012 10:14 am 
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Yea I figured this would be news to alot of people on the forum. Being a user and a stock holder it is definitely news to me!! I check bupe news around the world everyday and I'm also on this site all the time. This site helps out so many people and I know I'm not a huge poster on this site but when I have any news or just need to unwind you guys always provide a good read!! Just want to thank all the moderators and members for making this site what it is!! And of course Dr. J!!

Later


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PostPosted: Wed Sep 26, 2012 10:18 pm 
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That was very noble of them!!!

:lol:


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 Post subject: patches and new mg['s
PostPosted: Mon Oct 01, 2012 3:31 pm 
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theyre making, 4mg and 12mg and a patch.

http://www.drugs.com/mtm/buprenorphine-transdermal.html


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PostPosted: Mon Oct 01, 2012 10:17 pm 
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I'm unsure if RB are releasing a patch. The buprenorphine patch for pain management - aka Butrans - has been around for a while and is made by another company.

If RB is releasing a patch version of Suboxone I would be very very very interested.


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PostPosted: Mon Oct 01, 2012 10:21 pm 
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Oh my fucking God get a load of this... They're lobbying the FDA to ban buprenorphine in tablet form entirely... A really cynical maneuver to ban generic Subutex / Suboxone... Fucking assholes.

Quote:
Plans by Reckitt Benckiser to bounce US doctors and drug regulators into migrating addicts on to its patent-protected heroin substitute drug have been called into question after comments from one of the company's independent experts.

Reckitt, which is better known for making household goods such as Vanish, Finish, Dettol and Cillit Bang, still generates more than 20% of its operating profit from a legacy pharmaceuticals division which sells opioid dependency treatments – substantially to Medicaid-funded programmes in America. After 10 years marketing its suboxone pills in the US, the company said last week it had voluntarily decided to withdraw the tablets from the market. Reckitt told investors it had "received an analysis of data" indicating the pills were more likely to be accidentally taken by young children than an alternative version of the product – an under-the-tongue strip – also owned by Reckitt.

Strip suboxone is protected from competitor products by patent, but the tablet version lost its exclusive marketing rights in the US two years ago. Before the move last week, Reckitt had repeatedly warned investors to expect a fall of up to 80% in sales and profits from the tablets when a generic copycat pill reached the market.

Hours after announcing it was to withdraw the tablets, Reckitt revealed it had simultaneously submitted a so-called "citizen petition" to the Food and Drug Administration, urging the US regulator to ban any future competitor pills to its suboxone tablets that were insufficiently "child resistent". A company spokesman has insisted commercial motives played no part in Reckitt's decision to withdraw suboxone tablets from the market. However, Martin Deboo, an analyst at Investec Securites said: "We view these moves as consistent with Reckitt's strategy of protecting the suboxone franchise by hastening migration to [strip] and raising barriers to entry to generics."

The FDA has so far chosen not to ban the pills. "We can't comment on this issue as the agency has not yet reviewed the data leading to the sponsor's [Reckitt's] decision," a spokeswoman said.

Reckitt told the Guardian it had previously urged the FDA to impose such a ban but had been frustrated. "They were not prepared to accept our assertion that we thought that there was a paediatric exposure benefit of the [strip] without us providing scientific data to prove it." Under US law, the regulator is however obliged to review a citizen petition – though one US healthcare expert said the process often takes years and few such actions started by drug companies have been successful.

The Guardian has learned that the data analysis cited last week by Reckitt as the reason for withdrawing the tablets was commissioned by the company itself – a fact omitted from its statement.

Dr Rick Dart, executive director of Denver-based drug addiction monitoring group Radars, recruited by Reckitt to carry out the study, confirmed that the statement had accurately highlighted a significantly higher incidence of young children accidently exposed to suboxone pills when compared with child exposure rates linked to suboxone strips.

He said this appeared to be because each strip dose was packaged individually in a wrapper that was difficult for a child to open, while the pills came loose, in a bottle of 30.

Asked if Reckitt might have considered other alternatives than discontinuing the pills, Dart said: "There are other things they could do, certainly … They could put it [suboxone] in a blister pack. Every study shows that decreases exposure to small children".

A spokeswoman for Reckitt said: "We did look at the US suboxone tablets going into the new child-resistent blister packaging technology, but with the formulation of suboxone in the US we have not been able to develop a robust enough solution on which to submit a change. Even if we resolved these technical issues today, we would still have to go through the validation and regulatory registration change approvals process, which could take a minimum of another 9-12 months. "We were not prepared to wait on something yet unproven to implement the needed safety initiative."

The group pointed out there had been four child deaths in five years because infants had accidentally managed to get hold of its pills. "This is not a theoretical risk. It is real."

The latest official figures show about 2m Americans abused or were dependent on prescription opioid painkillers in 2010, with a further 400,000 people using heroin.

Last year, in a saga unrelated to suboxone, Reckitt was fined £10.2m by the Office of Fair Trading in the UK after it was found to have engaged in anti-competitive behaviour following the expiry of a patent on its Gaviscon heartburn treatment. The penalty followed whistleblower revelations which helped prove Reckitt had hoped to prosper by removing Gaviscon Original Liquid from a list of prescription drugs available to NHS patients shortly after the expiry of a patent.

This delisting, the OFT concluded, was designed to make it harder for chemists to identify cheaper generic alternatives and to boost sales of Reckitt's new variant Gaviscon Advance Liquid. The Advance Liquid product was in patent and therefore not subject to generic competition.

After initial denials, Reckitt did admit abusing its dominant position in the market for heartburn medicines. However it has not settled a parallel £90m civil claim brought by the Department of Health and filed more than 18 months ago.

There is no suggestion that moves to withdraw suboxone tablets from the US market risks breaching competition law, in America or elsewhere. "The RB Gaviscon case is in no way similar to that of suboxone and is irrelevant in this context," the company said. "This [suboxone] issue involves serious child safety risk."


http://www.guardian.co.uk/business/2012/oct/01/expert-questions-reckitt-benckiser-withdrawal-of-suboxone?newsfeed=true


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PostPosted: Mon Oct 01, 2012 10:23 pm 
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BTW Suboxone tablets in Australia have always come in blister packs, and we've had pretty much zero problems with pediatric overdose... And they're getting rid of them here anyway.

Another important bit that needs emphasis...

Quote:
The Guardian has learned that the data analysis cited last week by Reckitt as the reason for withdrawing the tablets was commissioned by the company itself – a fact omitted from its statement.


Fucking cynical maneuver.


Last edited by TeeJay on Mon Oct 01, 2012 11:19 pm, edited 1 time in total.

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PostPosted: Mon Oct 01, 2012 10:53 pm 
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RB DOES NOT CARE ABOUT CHILD SAFETY????!!!! RB...cares about money. What about Subutex....the generic I take
for ten dollars a month on my drug card?? Are they going to do away with that too...??? There are all kinds of safety
caps for children..childproof caps....I would think a child would be much more interested in playing with a pretty
colored film instead of a pill. I am all for saving children and making everything safe for them, but this is absurd....

This company has done everything it can to increase prices...hold on to patents...and make it hard for the addict to
afford their medication. The Drs. have been even less helpful in charging enormous prices for an office visit and refusing
to give anyone the generic subutex for monetary reasons. In their one day class these Drs. bought it all from RB..
and have learn nothing about the drug...most of us know tons more about bup than our Drs. With the ever increasing
rise in addiction to prescription pain killers it seems to me that SOMEONE out there would figure this thing out and make
some laws that help the addict get the med. to get well at a price he/she can afford, release the cap on the number of
addicts DR,s can have...and make this thing work to help the problem. Surely a few of these DRS really care about their
patients and it not about just all money? I think we could take two or three people on this forum and fix the rules quite
nicely...don't you agree???

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PostPosted: Mon Oct 01, 2012 11:55 pm 
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Un f-ing believable...

4 pediatric deaths in 5 years. Tens of thousands of teen deaths. Q: what will kill more people-- allowing tabs to stay, with generic competition allowed to push the prices much lower....

Or getting rid of tablets and EXISTING generic competition, pushing prices even higher so that people withou insurance can't afford Suboxone-- and more and more insurers try to save money by limiting coverage to one year?

Eliminating tabs is an obvious marketing ploy, shameful to the core--- but the 'citizen' petition is just plain evil.

Wow --- if my patients ever get the options that RB wants to prevent, I'm organizing the boycott of those bastards.

My prediction from a year ago: http://suboxonetalkzone.com/suboxone-business-fix/


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PostPosted: Tue Oct 02, 2012 12:21 am 
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Its almost in-humane..........................

seriously.......they REALLY are trying to do away with the competition.

the ONLY hope I see left is the "BEMA" film (buprenorphine/naloxone)

BioDelivery Sciences Announces Positive Results of Pivotal Pharmacokinetic Study Comparing BEMA Buprenorphine/Naloxone (BNX) to Suboxone
Released: 09/13/12 07:00 AM EDTNDA target remains on course for the second quarter of 2013
RALEIGH, N.C., Sept. 13, 2012 /PRNewswire/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced a positive outcome of the Company's pivotal pharmacokinetic study for BEMA Buprenorphine/Naloxone (BNX), which is being developed for the potential treatment of opioid dependence and utilizes the patented BioErodible MucoAdhesive (BEMA) technology to deliver buprenorphine combined with the opioid antagonist naloxone. Based on the positive outcome of this study, BDSI continues to anticipate that it will be in a position to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for BNX during the second quarter of 2013.

The study, BNX-103, was designed to compare the relative bioavailability of buprenorphine and naloxone between BNX and the reference product, Suboxone, which is currently approved for the maintenance treatment of opioid dependence. Based on the FDA agreed upon 505(b)(2) pharmacokinetic regulatory pathway for the BNX program, the goals of the study were to demonstrate that two key pharmacokinetic parameters, maximum drug plasma concentration (Cmax) and total drug exposure (area under the curve or AUC), for buprenorphine were comparable to Suboxone, and that the same parameters for naloxone were similar or less than Suboxone. These goals were achieved in the study.

"We are pleased with the outcome of this study and believe, based on our prior discussions with FDA, that the data supports a key component for our NDA," said Dr. Andrew Finn, Executive Vice President of Product Development. "The positive results of this study once again demonstrate the value and versatility of our BEMA drug delivery technology and its ability to effectively and efficiently deliver drugs to treat important medical conditions."

"The results of this study allow us to not only move a step closer to the potential filing of an NDA for BNX in 2013, but also advance our commercialization considerations that include furthering our active partnership discussions for BNX," said Dr. Mark A. Sirgo, President and Chief Executive Officer. "In the upcoming months, we will continue to evaluate our strategic options for the commercialization of BNX within and outside the U.S., including internal approaches, partnership or a combination of these. BNX is a significant asset to BDSI, and we believe, if approved, provides a relatively near-term opportunity to enter and capture a meaningful share of the over $1.2 billion and growing market for buprenorphine/naloxone by being the first film to compete directly against Suboxone."

http://markets.financialcontent.com/ir/ ... icker=BDSI
there's alot more, I just copied a snippet........................

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PostPosted: Tue Oct 02, 2012 12:28 am 
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Shame on them, don't know what else to say. They are goin to hell and if they are able to pull this off I am going to lose my shit.


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PostPosted: Tue Oct 02, 2012 12:30 am 
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And I'm on the films btw.


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PostPosted: Tue Oct 02, 2012 6:14 am 
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Unreal, but who among us is really surprised? We've all talked about RB before and how their tactics always seem to boil down to them protecting their patents ($$$). And yes, TJ, the bit about them not admitting that they commissioned the study, well, it's a typical way to slant a study. It's something that we always have to look at when looking at any study - not just how it was done, but WHO PAID FOR IT? This gives us a damn clear answer. It doesn't mean the study isn't valid, but it sure paints it suspiciously, and in RB's case, even more suspiciously.

Notice how these articles always seem to appear out of the UK and not the US? At least at first.

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PostPosted: Tue Oct 02, 2012 8:40 am 
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I wonder how many pediatric deaths each year result from oxy, roxi, hydro,morphine, etc. exposures each year? That statistic alone should be enough to call BS on RB's so called concern for children.


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PostPosted: Sat Oct 13, 2012 6:10 pm 
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My sub doc just told me about this so I came home and did some googling to confirm it.

There is no doubt that this is a ploy on RB's part to prevent generic tablets from entering the market and to keep their insane profits. This was a premeditated play on RB's part for sure.. file a patent on the film near when the patent on the tablet ends, then convince the FDA that Sub in tablet form (from any manufacturer) is dangerous and should not be approved...only their patent-protected cash cow the film should be on the market. This is gaming the system. As was said above, how many children OD on their parents' oxy or morphine tablets? Orders of magnitude more than for sub. It's all about the $$. This is anything but "noble."


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 Post subject: Harvesting Assets
PostPosted: Sat Oct 13, 2012 10:39 pm 
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Preventing kids from taking adult meds one would think making sure theres no sugar in the pills, and I don't how candy tasting pills get approved in the first place. I'm on low dose subutex ~1mg, comes wrapped in 0.4 doses and tastes like bitter salt. May be R/B should give us all "Property of ----" T shirts.


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PostPosted: Thu Dec 27, 2012 1:28 pm 
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I was stunned when I read this. I haven't heard word one about Tide pods being removed from the market, and it sounds like it is much more prevalent than Suboxone exposures:

Excerpt from article:
Ten minutes after a 20-month-old swallowed a laundry detergent packet, the child developed profuse vomiting, wheezing and gasping and then became unresponsive to even painful stimuli.

A 15-month-old who bit into a pack and swallowed a mouthful had profuse vomiting and, after arrival at a hospital, had to be put on a ventilator for airway protection.

A 17-month-old bit into a packet and then rapidly developed drowsiness, vomited, breathed the product into the lungs and had to be put on a ventilator.


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PostPosted: Wed Feb 06, 2013 4:03 pm 
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Unreal.. 4 deaths in 5 years.. so they take the tabs off the market?? what about every other medication in this world, they come in tab form also.. I def. dont like this company.. another reason why i will stay on subutex.. i will never give another dollar of my money to RB.. i would get off sub b efore that ever happened.


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