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Suboxone: The Light At The End Of The Tunnel

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 New Suboxone "Film" approval

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nannamom
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nannamom


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Humor : Once you choose hope, anything’s possible. -Christopher Reeve
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PostSubject: New Suboxone "Film" approval   New Suboxone "Film" approval EmptyThu 16 Sep 2010, 9:37 pm

New Suboxone "Film" approval News_r10




Reckitt Benckiser Group Plc on Tuesday said its pharmaceutical unit has got US Food and Drug Administration (FDA) approval to make and sell its new drug Suboxone sublingual film to treat opiod dependence.

The specialty pharmaceutical company said the new drug has been developed using MonoSol Rx's proprietary PharmFilm technology through an agreement, to provide the opioid dependence treatment Suboxone in a fast-dissolving sublingual film.

The company said Suboxone sublingual film will be available from early October to patients in same doses as currently offered by Suboxone (buprenorphine and naloxone) sublingual tablets C-III.

Suboxone sublingual film helps maintain treatment of opioid dependence and should be used as part of a complete treatment plan to include counselling and psychosocial support, it said.
"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," said Shaun Thaxter, president of Reckitt Benckiser Pharmaceuticals Inc, in a statement.
Reckitt Benckiser Pharmaceuticals Inc makes and sells Suboxone (buprenorphine and naloxone) C-III sublingual tablets and Subutex (buprenorphine) C-III sublingual tablets and formulations of buprenorphine used to treat Opioid Dependence.

MonoSol Rx's PharmFilm technology is designed to benefit patients by improving the convenience, efficacy, and compliance of new and currently marketed drugs.

The company has also issued some safety norms for administering its Suboxone sublingual film. It has warned patients against taking this drug for those hypersensitive to buprenorphine or naloxone while cautioning that chronic use of buprenorphine can cause physical dependence.

A sudden or rapid decrease in dose may result in an opioid withdrawal syndrome that is typically milder than seen with full agonists and may be delayed in onset, it said.

Suboxone sublingual film can also cause serious life-threatening respiratory depression and death particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other central nervous system (CNS) depressants (sedatives, tranquilisers, or alcohol), the company said.

The pharma company said the new drug is extremely dangerous to self-administer nonprescribed benzodiazepines or other CNS depressants while taking Suboxone sublingual film and that liver function should be monitored before and during treatment.

Opioid dependence is a medical diagnosis characterized by an individual's inability to stop using opioids (morphine/heroin, codeine, oxycodone, hydrocodone, etc) even when it is in his or her best interest to do so.

News Article Written by IB Times Staff Reporter
August 31,2010
Source:
International Business Times
Posted by: Dee
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nannamom
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nannamom


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Number of posts : 2210
Age : 66
Humor : Once you choose hope, anything’s possible. -Christopher Reeve
Registration date : 2008-11-09

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PostSubject: Re: New Suboxone "Film" approval   New Suboxone "Film" approval EmptySat 18 Sep 2010, 4:27 pm

Some Additional Information





*Data on file, Reckitt Benckiser Pharmaceuticals Inc., Richmond, VA:

Patient preferred:
Clinical trial participants preferred SUBOXONE Film over the SUBOXONE Tablet. Results from a questionnaire collected at discharge of a 13-week, multicenter, open-label safety trial. Patients were asked, "Based on your previous experience with SUBOXONE Tablet and your current experience with SUBOXONE Film, which product do you prefer?"

Dissolve time:
The time required for both SUBOXONE Film and SUBOXONE Tablet dissolution is dependent on saliva quantity and is subject to individual variation, and dose and strength taken. Mean dissolution time for all doses tested (8 mg, 2 mg) was between 5 and 6.6 minutes for SUBOXONE Film and between 7 and 12.4 minutes for the SUBOXONE Tablet.

Taste:
In a patient questionnaire, more than 71% of patients who have tried SUBOXONE Film rated the taste as neutral or better on a 10-point scale. Results from a questionnaire collected at discharge of a 13-week, multicenter, open-label safety trial. Patients were asked, "Please give this product (SUBOXONE Film) a score which shows how you would rate the flavor." 10=extremely pleasant and 1=extremely unpleasant.

Portability:

Because each unit of SUBOXONE Film is individually packaged in a compact, child-resistant pouch, it's easy to carry with you. Remember to keep this medication out of the sight and reach of children, and take your prescription label along with you. If a child takes the medication, seek emergency care.

Child resistance:
Meets the Consumer Product Safety Commission's standards for child resistance. During testing, one child out of 50 was able to open 2 or more pouches. After receiving instruction, the children's ability to open the pouches increased. It is important not to open the pouches in front of children.

© 2010 Reckitt Benckiser Pharmaceuticals Inc.
Full product information for Suboxone "Film" (PDF file)
http://heretohelpprogram.com/pdfs/SuboxoneSublingualFilmPI.pdf



Discount Coupon Offer

The makers of Suboxone; Reckitt Benckiser are offering a discount coupon that will save up to $75.00 per month on your prescription of Suboxone film, this discount does not apply towards the Tablet form of Suboxone. One prescription per month. This offer will be good until March 2011.
Click here for the Discount savings coupon
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MarkHelpsAll




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PostSubject: NEW SUBOXONE SUBLINGUAL STRIPS !!   New Suboxone "Film" approval EmptyThu 30 Sep 2010, 4:52 pm

Just got back from my Suboxone appt and the doctor asked me to switch to new Suboxone STRIPS. They are sort of like Listerine breath strips. They go under the tongue just the same. Available in the same dosage. I imagine that all Suboxone will switch to this. I talked a while with the doct and they are doing this to cut down on diversion to Suboxone to the street. Every strip packet has a unique serial number. I don't know if the pharmacy logs all but it would be real easy to track down where they came from if sold blackmarket. ALso, the doc asked me to bring back the empty packets. The docs can use this as verification that the Suboxone was not diverted. I suppose technically somebody could take the little strip out and sell it but I have to wonder what the life of the strip is once it is out of the packet. It could just dissolve on its own.

ALSO, IMPORTANT!! the makers of Suboxone have given introduction packets to doctors that explain the new strips and come with a card worth $75 off Suboxone, either cash or off your drug copay. And the card is actually good for more than one use although it can only be used once a month. My copay was $40 and I got mine for FREE with the card. Apparently it still has $35 on it for my next fill.

I suspect that they will phase out the tablets fairly soon as technically, there really is no reason for them to have both since the dosages are the same.

as a side note, I sort of liked the flavor of the tablets . The new strips aren't the greatest tasting but certainly didn't gag me either.
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nannamom
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nannamom


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PostSubject: Re: New Suboxone "Film" approval   New Suboxone "Film" approval EmptyThu 30 Sep 2010, 5:42 pm

Hi Mark
That's great. As you can see I merged this post over with one that I had posted when the FDA gave the approval for the new strips, to keep everything together on the forum.
I am glad to be able to talk with someone who is actually trying them out.
Did you doctor say that he was going to be prescribing the strips only or will he give the patients the option of staying with the tables if they want to?

That's an interesting thing you brought up about each strip having it's own product ID number on it. And actually it is a good idea for providers to require their patients to bring back the packaging on each appointment. I'm not sure if it will actually cut down on the diversion of Suboxone but it will make it more difficult for people to sell them. And like you said it will make it easy to trace them back if sold on the black market. So maybe it will cut down on diversion after all.

The discount card that you got can be used once a month through the end of March 2011, that will be a great relief to the patients who have a large co-pay. From what I was able to read on the manufacturers website, the card will be good for 75.00 each month. And it that is right you will have $75.00 off of your prescription next month as well.



Quote :
"I suspect that they will phase out the tablets fairly soon as technically, there really is no reason for them to have both since the dosages are the same."

That could be true and maybe I shouldn't say this, but I wonder if they will phase out the tablets. In most medications there are more than just one type of the medication, now with Suboxone being available in not only tablet form but a film strip as well, I would imagine the profit margin for the company will jump at least during the introduction time period. I guess this is something we will have to wait and see.
Thanks again for sharing that information.
Dee

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MarkHelpsAll




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PostSubject: Re: New Suboxone "Film" approval   New Suboxone "Film" approval EmptyThu 30 Sep 2010, 6:03 pm

I am not sure if my doc is going to prescribe JUST the strips or still do tabs too. I will ask on my next appt.

I think part of the reason he had me switch right away is that I am on three 8/2 per day and I've heard that the common opinion among the feds and many doctors is that anything prescribed over 2 / day ends up on the street.

Not from me though. I've never diverted one single tab the entire time I've been on Suboxone.

I think my doc was almost afraid that I would be offended when he asked me to bring the empties with me next appt but it was fine with me.

I am sure that the strips will cut down on diversion by some degree, how much, who knows?

I did notice that the strips absorbed and worked much faster than tablets.

I almost felt a sort of "RUSH" but NOT a high type of rush, just a feeling of the Suboxone entering my system quickly.

Other than that, I think the new strips will be fine for me.

What the FUTURE brings I have to wonder though. The tablets probably cost almost nothing to make compared to the individually packaged strips. And if the unit production price is much higher, does that mean it will be passed on to us and if so, how much?

It's possible that docs might just prescribe the strips when they have a question about whether individual patients are diverting.

BUT, i have to wonder if they will be MORE inclined to prescribe the strips from a "cover my A$%" standpoint.

It is going to be a lot harder to divert just the strips if the patient has to bring back the empties. The strips are very thin and flimsy. I think it would be fairly hard to maintain them outside the packet for very long due to moisture , handling, etc.

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MarkHelpsAll




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PostSubject: Re: New Suboxone "Film" approval   New Suboxone "Film" approval EmptyThu 30 Sep 2010, 6:23 pm

One thing I am not sure on is the discount card. I couldn't tell if it is worth $75 total or $75 every months until March 2011. I won't know until my next fill. It sure would be great if it was $75 every month !!
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nannamom
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nannamom


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Humor : Once you choose hope, anything’s possible. -Christopher Reeve
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PostSubject: Re: New Suboxone "Film" approval   New Suboxone "Film" approval EmptyThu 30 Sep 2010, 10:21 pm

Mark
About the savings. I just went to the website and this is what they have to say:

Get up to $75* in savings each time you fill your SUBOXONE Film prescription (limit one prescription per month), now through the end of March 2011.
And here is the link to check it out:
http://suboxone.com/patients/here_to_help/savings.aspx?cid=sav/Default.aspx?cid=hthpf
Dee
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MarkHelpsAll




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PostSubject: Re: New Suboxone "Film" approval   New Suboxone "Film" approval EmptyFri 01 Oct 2010, 7:06 am

HELPFUL HINT FOR OPENING STRIP PACKAGES.

I noticed when I opened one of the stip packages that a small piece of the Suboxone film got torn off with the tear strip.

You can avoid this by tapping the opposite edge of the packet to shift the film away from the tear area, sort of like the way people hit the end of a pack of cigarettes to tighten the tobacco to one end.

It wasn't a big deal but since the strips are fairly small and expensive, no sense wasting part of one.

and if I was on the panel rating taste, I would have given it about a 2 on a 1-10 scale. Some people may like it better though
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nannamom
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nannamom


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Humor : Once you choose hope, anything’s possible. -Christopher Reeve
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PostSubject: Re: New Suboxone "Film" approval   New Suboxone "Film" approval EmptySat 02 Oct 2010, 10:59 pm

Thanks Mark
I'm sure your post will help many who have or will be doing the switch over to the strip. As for me, my provider hasn't brought it up yet. I had my appointment with her on Tuesday this week.
I don't see her again until next month so I'll see what she says.
A 2 on a scale of 1-10 huh?
I imagine I could get used to it if I had to as I did get used to the tablet. Now days the taste of the tablet doesn't bother me at all.
After four years it shouldn't.
I will admit that after reading about it from someone who has knowledge of it, I am leaning more towards trying it if my provider will agree to it.
I'm sure I'll have to get another prior authorization since it is a different form but that's ok. It only takes but a minute as long as my provider makes the call while I am sitting in her office at the time.
I'll let ya know.
Dee
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