Bunavail

Buprenorphine Post
drpasser
Posts: 1404

Postby drpasser » Tue Jan 13, 2015 6:56 am

I'm still six for six, disliking Bunavail. I wish it wasn't so.

Each, more or less, independently complained of similar problems. They felt withdrawal symptoms, which I believe, based on the erroneous dosing recommendations from the company, which is something that I'm not happy about. Pts could potentially relapse and die. And they all say, they were left with this sticky gooey glob of stuff in their mouths, that never dissolved or went away. Most just swallowed it, even after 45 minutes of waiting. Then, they weren't certain if they had gotten all of it or not. But maybe not, as they experienced withdrawal.

Best
Kevin

NoDrugs4u
Posts: 198

Postby NoDrugs4u » Tue Jan 13, 2015 6:56 am

Very nice explanation, ckheb, thank you.

fishdoc
Posts: 111

Postby fishdoc » Tue Jan 13, 2015 6:56 am

I had a patient today complain that when Bunavail is in his cheek, "It melts and drips inside my mouth, then leaves my cheek sticky." Upon further questioning, we discovered that he was inserting the film backwards. Apparently both my instructions and the booklet he was given were not clear enough for him to understand.

For those patients who complain that their cheek is sticky after Bunavail, make certain it is inserted with the writing facing the cheek.

ckheb
Posts: 25

Postby ckheb » Tue Jan 13, 2015 6:56 am

OK, folks...I've spent a lot of time trying to sort out the Bunavail confusion....It is a film product and should work well, eventually.

When a new product of Bup/Naloxone is presented to the FDA, it must be shown to be 'equivalent' to whatever the FDA is using as their 'Standard.' Not surprisingly, the current standard is the first one on the market, Suboxone Tablets. So Zubsolv, the generics, and now Bunavail have been shown to be roughly equivalent to Sub tablets. When Suboxone Film was certified, it was shown to have roughly 30% higher blood levels than the tablet. R-B even included a warning that, in changing from tablets to the film, a downward unit dosing may be necessary. But, in general, everyone just went with 'One tablet equals one film,' Well, that same tendency has remained as each new product has emerged...Except that one Zubsolv is 30% weaker than what is now considered, in the Addiction World, the real standard, Suboxone Film. Zubsolv is, of course, just a reincarnation of the Suboxone tablet except that its quick dissolve, 'pleasant, minty flavor' characteristics cause a mouthful of saliva with resultant poor absorption. Bunavail, with its BEMA technology (BioErodable MucoAdhesive) gives a blood level just a little higher than the Sub tablet, but still not as high as Sub film. The uni-directional buccal film technique does allow absorption probably twice that of the absorption of Bup sublingually, allowing about half as much Bup to be used to achieve the Sub tablet level. Residual amounts of Bup and Naloxone are, therefore, substantially reduced, resulting in much less nausea and constipation.

But the point is that these Pharma companies are not divulging adequately that one Zubsolv or Generic or Bunavail IS NOT equivalent to one Suboxone Film. Many of the failures above are simply due to using the one-to-one unit dosing, resulting in substantial under-dosing of Bup. I don't pretend to be able to understand Zubsolv dosing, but Bunivail has consistently been equally efficacious to Sub Film in a 1:1.3 Sub:Bunavail ratio (or there-abouts.) It just requires clinical titration for effect.

As for the complaint of the Bunavail 'Gummy Bear' being around for an hour or 2,the Onsolis Fentanyl Patch uses the same BEMA technology, and more rigorous plasma level testing has shown that about 90% of the med is absorbed at 15 minutes. I suspect the same is true for Buprenorphine, so that after 20 - 30 minutes, the 'Gummy Bear' can be spit out or swallowed.

It's late, I'm tired, and you're bored...

Dave
Posts: 187

Postby Dave » Tue Jan 13, 2015 6:56 am

I had one patient confess that subutex can give such a brief high taken as directed. That is probably why it is in demand as a street drug because it can produce a high even better when injected. I would expect Bunavail to be more slowly absorbed because the drug is in a sticky matrix that is more like a slow release formulation.

mack86
Posts: 70

Postby mack86 » Tue Jan 13, 2015 6:56 am

Thought I'd share one pts interesting revelation:

She had been stable on suboxone films 2x8 mg/day for 2 years, and I switched her to bunavail 2 x4.2 mg. The first week she reported a lot of difficulty, told me it was sticking to her finger or teeth, rolling up. Spent a lot of time discussing proper placement. Finally had her use tweezers so she wasn't handling the film at all. Tried placing in between cheek and gum, thinking that way it wouldn't matter which side she placed on the cheek.

She still kept saying "it isn't working." I asked her how "it isn't working" - asked about cravings, etc. No cravings. She was quiet a moment, then she said, "I guess it is working. With the suboxone I usually get this little head rush for just a moment when I take the strip. I don't get that with the bunavail, so I thought it wasn't working. But I guess it is working, I still have no cravings. So maybe it's better, because that little head rush might not be a good thing for me."

I have never had a pt describe "a little head rush" from suboxone before. I'd never asked. Perhaps a slower absorption of bunavail (because of its unidirectional flow?) accounts for this? So perhaps that it takes longer for the film to "go away" is an advantage, and pts should just be counseled to be patient.

fishdoc
Posts: 111

Postby fishdoc » Tue Jan 13, 2015 6:56 am

ROLLING on the floor laughing!

kcairns
Posts: 571

Postby kcairns » Tue Jan 13, 2015 6:56 am

when in doubt daily observed dosing safest...w bn tho data is of marked decreases in morbidity mortality...but yes of course a pt may exhibit much prosocial improvement and stay alive while reaping the extra "benefits" of injecting film/snarting pills etc putting selves at increased risk for major relapse, injecting we could find from veins but snorting of course no way for us to know...if I know a pt is snorting I would rather send to daily observed dosing than to fight w smarter partial agonists but can also make the case if bunavail really is less snortable that we could help pt help self by rxing such...perhaps only the shadow knows (if under 70 just ignore that)

drpasser
Posts: 1404

Postby drpasser » Tue Jan 13, 2015 6:56 am

Snorting is abuse.

I've had pts snort both the mono and the combo product.

I agree, that the mono product is more euphorigenic.

People will abuse anything. In the 70s, there were people who used IV peanut butter.

I've often thought, if there were no drugs at all in the world, some people would become dependent on rolling down hills, if only just to become dizzy with an altered state of consciousness.

Dave
Posts: 187

Postby Dave » Tue Jan 13, 2015 6:56 am

Kcairns and NoDrugs4u, I have had the same experience as NoDrugs with many people finding out about Suboxone on the street and then finding a legal way of dealing with their problem. Methadone is also a street drug, and I haven't heard any frantic talk about restricting it or finding another delivery system to reduce diversion of that potent opiate. The DEA's business is enforcing the law, not interfering with medical practice and the rescue of a large number of people from the vast epidemic of opiate addiction.

Remember how Suboxone got approved for OBT originally on the basis of the company's claim that the naloxone component prevented misuse? Now we know otherwise. Actually I knew otherwise many years ago from patients telling me about how it could be dissolved and injected without producing withdrawal. The fortunate thing is that it can precipitate withdrawal too. It depends on how it is done, and I am not going to tell. It is best kept a secret.

Despite all this, we still have a good way to reduce the thousands of deaths every year from prescribed and street drugs. I hope the DEA does not eventually prohibit Subutex in the generic form, because that would condemn many poor people who cannot afford the more expensive drugs like Bunavail. It is better to try to reduce diversion as we are doing than to condemn the poorest people to an early death.


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