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PostPosted: Sun Sep 05, 2010 10:03 pm 
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FDA Approves Suboxone Sublingual Film
Reckitt Benckiser Pharmaceuticals Inc. Receives FDA Approval for Suboxone (buprenorphine and naloxone) Sublingual Film C-III



Richmond, VA (31st August 2010) – Reckitt Benckiser Pharmaceuticals Inc. today announces that it has received approval from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) to manufacture and market Suboxone sublingual film. Suboxone sublingual film has been developed through an exclusive agreement with MonoSol Rx, utilising its proprietary PharmFilm technology, to deliver the opioid dependence treatment Suboxone in a fast-dissolving sublingual film.


Suboxone sublingual film is indicated for maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counselling and psychosocial support. Prescription use of this product is limited to physicians certified under the Drug Addiction Treatment Act, 2000.

Suboxone sublingual film will be available from early October 2010 to patients in the same doses as currently offered by Suboxone (buprenorphine and naloxone) sublingual tablets C-III. A Risk Evaluation and Mitigation Strategy (REMS) program is being implemented as part of the FDA requirements to ensure that the benefits of treatment with Suboxone sublingual film outweigh the potential risks, particularly risks of accidental overdose, misuse and abuse.

Commenting on the FDA's approval, Shaun Thaxter, President of Reckitt Benckiser Pharmaceuticals Inc. said: "The development of Suboxone sublingual film through our exclusive agreement with MonoSol Rx reinforces our commitment to our opioid dependence therapy franchise and to its development. During clinical studies, Suboxone sublingual film was shown to be faster dissolving than Suboxone sublingual tablets. Because of the faster dissolution and the taste profile, patients preferred the film. Each individual dose of Suboxone sublingual film will come in a child-resistant pouch.

Our partnership with MonoSol Rx represents a strategic business opportunity which will contribute to the longevity of Suboxone in the U.S."


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PostPosted: Wed Sep 08, 2010 12:53 am 
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**cough** patent extender **cough**

I don't see any reason to not go generic sublingual tablet personally, especially if I can get it a bit cheaper!


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PostPosted: Thu Sep 09, 2010 12:23 pm 
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Here is a link to get an alert when it hits pharmacies and to also receive a discount of up to $75.00 per fill

http://www.heretohelpprogram.com/suboxo ... fault.aspx

It will be priced the same as the tablets BTW...


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PostPosted: Wed Sep 15, 2010 1:15 pm 
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Well I for one am excited about the "film" I hate the pills. I just got an email this morning with the link that hpchris put up so this is all news to me. I'm currently in the process of tapering from 4mg to 2mg (originally started at 8mg) the smaller dose is a isn't quite as unpleasant as the bigger dose but still the film looks like a good alt.

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PostPosted: Sun Sep 26, 2010 8:00 pm 
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Looks like Reckitt Benckiser are trying new things since this stuff went generic. I'm sure there losing some money.


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PostPosted: Sun Sep 26, 2010 8:35 pm 
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I will be getting the film on my next refill. By the time the 75.00 discount expires I'll be done with my treatment.

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PostPosted: Tue Sep 28, 2010 8:19 pm 
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Switching also. My next refill is for the film. Gonna try it at least, really hope it dissolves faster like they say.


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PostPosted: Tue Sep 28, 2010 10:41 pm 
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I just read in the pamphlet the Dr. gave me that patients switching from tablet to film should be monitored for over-medication because the film has better bio-availability. Maybe a good chance to "taper" a little. I want to taper and have been finding it tough due to life-circumstances (wedding approaching) to even try but it's always in my mind. I asked my Dr. what he thought about cutting the film in order to taper and he said it was a good idea, he hadn't thought of it. I saw the sample film he had and its not super tiny. Looks like it would be easy to measure and be pretty precise.

No one is excited about this film? Waiting up to an hour for the tablets to dissolve has been kind of a drag for me.

I will be sure to report back, starting in 5 days or less depending on the pharmacy. Got that $75 off card too.

:)


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PostPosted: Thu Sep 30, 2010 9:00 am 
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this sure is exciting for me, it takes my tablets almost 2 hours to dissolve!!! craaaaaaaaaaaazzzzyyyyyyyyyyy

i have some whacky spit...but the film brings me new hope...although i have been clean for 305 days, bc the tablets take so long to dissolve, in certain aspects i still act like an addict...planning my day around taking he pills, not going out with my friends bc i know i have to put them in before bed and then in the am i have to get up extra early for school to get them in

so i for one am extremely excited, and those of you who say why switch if the tablet is working...well if it is taking an hour to dissolve...ITS NOT WORKING!!! why not try the film? if you dont want to atleast try the film, thats the addict in you not watning to switch to something new...and by no means am i trying to be a negative nancy, just wanted to throw that out there...i saw on some other blogs people not wanting to switch...but if it can take 10 minutes instead of atleast 60 minutes!!! why wouldnt you want to switch?!?! (i understand if people are taking it and it only takes 10 minutes to dissolve, he tablets that is, but this statement is more for those of us who have to sit around for atleast 60 minutes to have these life changing medicine dissolve)

hope everyone is doing well and stay strong!!!

"my worst day sober is always better than my best day high"


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PostPosted: Thu Sep 30, 2010 12:58 pm 
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Hi Everybody,

I was wondering how do you get the discount card for the film? Does your doctor just give it to you? And, how long is the discount for (how many months, or prescriptions)? If anybody who is knowledgeable in this could let me know that would be great.


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PostPosted: Thu Sep 30, 2010 6:29 pm 
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Your doctor will give it to you when you get your script and it's good for 6 months and it's 75 bucks off your out of pocket expense including your co-pay. Last night I tried to see how small i could cut the strips and I cut an 8 mg strip down to .25 mg pieces easily and could prob get down to .125 mg.


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PostPosted: Thu Oct 28, 2010 12:35 pm 
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I take 24mgs, you have to cut these packages open across the top then rip them down the sides, so you need a scissor for sure( or use your teeth, I guess,lol), if you take your doses in a car on the way anywhere this is not going to happen, it is a pain in the A##. Then if you have any problems with dexterity well, that is a whole other issue! If you happen to drop one on wet surface, you'd be sh#t out of luck too, in my opinion! I just started these and they are not my cup of tea at all. 3 boxes with 30 in each box, instead of one pill bottle?? How does that make sense?? Keeping track of 3 boxes? The packages looks like condom wrappers. Nope going back to the Doc, this is not for me. I have MS and getting one package open was a problem, but 3? Sometimes I take my dose on my way to my daughter's house, not anymore, this is one big ritual! If I pulled over to the side of the road to open these, a cop would think I opening a bag of smack or coke!!! Thanks but no Thanks! Today was my first dose, 3 of these in my mouth. I don't know yet if they are the same or different, I am still sitting here with a mouth full of saliva, same amount of saliva! The taste isn't as bad. I"ll be back in a few days to let you know if there is a difference. I for one, DO NOT PLAN ON TAKING THESE AGAIN, TOO MUCH RITUAL AND TOO MUCH BULK to keep track of, this is a disaster waiting to happen for me! 3 boxes versus 1 bottle, scissors to cut the wrappers...nope not for me, just hope I can finish this month with these without something going wrong! I vote the pills any day!

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PostPosted: Thu Oct 28, 2010 2:26 pm 
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You don't need scissors to open the package it's got a notch in it so if you read the package it tells you how to do it. I def like the strips better you don't look like a rabid dog with orange crap around your lips when your done with your dose. They're more potent than the tabs I went from 4 pills to 1 and a half strips and absorption time is more than cut in half, and I actually think the strips are more convenient to carry, I take my dose to work with me in my wallet instead of having to carry around a rattling pill bottle. And you can't cut an 8 mg pill down to an eighth of a mg like you can the strip. My doc made everybody switch to the film, the reckitt reps are asking doctors to switch their patients.


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PostPosted: Fri Nov 19, 2010 9:12 am 
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These strips are AWFUL. I am more upset that my doctor is MAKING me switch. The pills work fine....I take a tiny peice of a pill each day but now I have to cut these tiny little peices of paper and its such a pain, I always loose the open package and personally I think the strips taste terrible. Its so unfair to MAKE us switch to something we find less convenient, I understand the only reason they are switching is because its supposed to be easier and more convenient...well if I'm telling my doctor it is NOT more convenient anjd she still refuses to let me go back to pills....I feel like she has alternative reasons....are doctors getting incentives to switch patients to strips??? I HATE THAT PHARMACUETICAL COMPANIES CONTROL PATIENT CARE AND NOT DOCTORS!!!! My doctor says you have to switch because everyone is switching....???? What kind of reason is that? She says they are better....??? Well if I say they aren't and I'm the one taking them WHY WON'T SHE SWITCH ME BACK???? Please if there are any doctors reading this please tell me what is going on why is my doc making me switch aginst my will???


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PostPosted: Fri Nov 19, 2010 10:24 am 
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Dr. Paul - Many of us believe that the manufacturer started these new strips so that they will have a brand new patent. Some say they will even be phasing out the pills, which sucks if you ask me. I'm like you - I cannot stomach the taste of the film. They make the tablets taste like candy.

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PostPosted: Fri Dec 10, 2010 2:41 pm 
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[quote="SUBliminal"]You don't need scissors to open the package it's got a notch in it so if you read the package it tells you how to do it.

Well I have MS and believe me I need the scissors, it is not so easy for someone with a neurological condition!

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In a night, or in a day,
In a vision, or in none,
Is it therefore the less gone?
All that we see or seem
Is but a dream within a dream."
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PostPosted: Fri Dec 10, 2010 2:45 pm 
hah subliminal the strips are far from "more potent than the tabs", they are a pain in the ass and end up stuck in the wrong spot so easily and the absorbtion is no better. Pills held me so much better than the films. I already had enough of a problem feeling maintained with being on the tablets and If I have to stay on the film its just another push for me to get on methadone sooner (which i will be doing its just a matter of time so I can afford it)


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PostPosted: Fri Dec 10, 2010 3:23 pm 
This approach Reckitt Benkiser is taking is soooo obvious!! Its absolutely a patent-extender. It has to be!! I just dont believe that its for the better good of the people. I believe this strip thing is a scam. Personally i take subutex but i cant help but be angry with how this company treats the people they claim to be concerned about. Their wasnt 1 single thing wrong with those tablets. I've never tried the strips but i started my treatment with the tablets and they worked just fine, other than me finding out they have an artificial sweetner in them which im allergic to. So, the only logical reason for them to make another version of suboxone, which is retarted is to keep their business running. Think about it, if someone came out with generic suboxone, Reckitt would be screwed because nobody in their right mind would pay their prices unless the generic didnt work for them or they had insurance. I could go on and on and on but i would be here all day. Anyways, thats my 2 sense about the strips.


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PostPosted: Wed Jun 08, 2011 5:45 am 
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What would you tell the food manufacturer if you were the spokesperson for the FDA? Entire Question: A food manufacturer is advertising a new cake mix as fat-free. Scientists at the U.S. FDA are testing the product to see if it truly lacks fat. Hydrolysis of the cake mix yields glucose, fructose, glycerol, a number of amino acids, and several kinds of molecules with long hydrocarbon chains have carboxyl group at one end. What would you tell the food manufacturer if you were the spokesperson for the FDA?


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PostPosted: Tue Jul 26, 2011 1:45 am 
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Anybody knows the details of FDA approval? I have a Lutein health care product need to get approval by FDA, anybody knows how and how long will it take? i need some details, thank you :)


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