Bunavail Question

Buprenorphine Post
Posts: 32

Postby mattkeene » Tue Oct 06, 2015 8:39 am

That impacted me as well but the issue was quickly resolved. They used a different supplier for on the the polymers in their matrix and needed to get specific FDA approval to switch polymers. The FDA and Bunavail folks addressed this pretty quickly. They issued a press release one day stating we could face delays...then the next day issued another press release stating the problem was solved.

I've become an advocate for this particular formulation. It seems to have the lowest abuse potential, and hence less diversion risk. Constipation seems to be significantly less. For me, the biggest barrier is plan coverage.

Posts: 64

Postby adavid » Tue Oct 06, 2015 8:39 am

My Bunavail rep informed me that the issue was that the company had switched to a different manufacturer which used a some different polymer which was not FDA approved. As of a week ago FDA did issue approval and product has been shipping. It is back in the pharmacies.

Also, I find the discussion of sublingual use of Bunavail somewhat perplexing. One of the perks of the buccal use of this product is that it keeps the buprenorphine off the tongue/taste buds. Bup has a bitter nasty taste so why would you want it back on the taste buds???

Posts: 111

Postby fishdoc » Tue Oct 06, 2015 8:39 am

Has anyone heard of a change in the Bunavail formula that has temporarily created a situation where Bunavail is unavailable pending approval of the new formula? It has become even more difficult for patients in northeast Ohio to obtain and I was told this is the reason.

Posts: 187

Postby Dave » Tue Oct 06, 2015 8:39 am

I would be concerned that the off-label sublingual use of Bunavail may not deliver all the bupe. Saliva collects under the tongue and may dilute the patch by leaching the drug at the edges. The sublingual route may also be uncomfortable for some people since the patch is a lot more rigid than a film strip of Suboxone. However, I have no doubt it can work and be absorbed sublingually. But the actual administered dose may be a little less than given by the buccal route. You can find out if the patient starts asking for a larger dose.

The fact that the standard dose of bup (4.2 mg) in a buccal patch is about half of that in a sublingual film (8 mg) should make us wary.

Posts: 111

Postby fishdoc » Tue Oct 06, 2015 8:39 am

Make certain the active side of the Bunavail patch is contacting the mucosa: unlike Suboxone, the two sides of Bunavail are NOT the same. The sublingual application of Bunavail, however, should be quite uncomfortable due its shape, size, and stiffness.

In my experience, when a Bunavail fails to adhere, it has been applied with the active side side facing the teeth, not in contact with the buccal mucosa.

Posts: 180

Postby entjwb » Tue Oct 06, 2015 8:39 am

Sorry, buccal not Buccaneers.

Posts: 180

Postby entjwb » Tue Oct 06, 2015 8:39 am

The clinical trials used Buccaneers application so that is what needs to be what they recommend. Sublingual would be off label usage, but should be just as effective.

Posts: 1404

Postby drpasser » Tue Oct 06, 2015 8:39 am

I can't think of any reason why sublingual wouldn't work the same as buccal administration. It's all mucosa.

Kevin :-)

Posts: 10

Postby timbaldwin1 » Tue Oct 06, 2015 8:39 am

good idea. Its mucous membrane.Also lemon juice one drop helps.

Posts: 198

Postby NoDrugs4u » Tue Oct 06, 2015 8:39 am

Wow, from reading posts on this forum it seems like Tennessee and Kentucky are tough places to practice MAT. So many rules and regulations (i.e. - politicians) seem designed to circumvent a physician's judgement. Sympathy for those docs fighting the good fight in those states!

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