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FDA approves Belbuca, new pain medication delivery system

Oct 27, 2015 5:35 AM

the U.S. Food and Drug Administration (FDA) has approved Belbuca (buprenorphine) buccal film for use in patients with chronic pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Belbuca, which is the first and only buprenorphine developed with a dissolving film that is absorbed through the inner lining of the cheek for chronic pain management, is expected to be commercially available in the U.S. during the first quarter of 2016 in seven dosage strengths, allowing for flexible dosing ranging from 75 μg to 900 μg every 12 hours. This enables physicians to individualize titration and treatment based on the optimally effective and tolerable dose for each patient.


“The availability of new, convenient and flexible treatment options is important for patients whose lives are burdened by chronic pain, a debilitating condition that affects more Americans than diabetes, heart disease and cancer combined,” said Richard L. Rauck, M.D., Director of Carolinas Pain Institute, Winston Salem, NC. “Belbuca provides a unique approach for chronic pain management, combining the proven efficacy and established safety of buprenorphine with a novel buccal film delivery system that adds convenience and flexibility. For both opioid-naïve and opioid-experienced patients who require around-the-clock treatment and for whom alternative treatment options are inadequate, Belbuca offers appropriate, consistent pain relief and a low incidence of typical opioid-like side effects.”

Belbuca is a mu-opioid receptor partial agonist and a potent analgesic with a long duration of action that utilizes BDSI’s patented BioErodible MucoAdhesive (BEMA®) drug delivery technology. Through this unique delivery system, buprenorphine is efficiently and conveniently delivered across the buccal mucosa (inside lining of the cheek). Buprenorphine is a Schedule III controlled substance, meaning that it has been defined as having lower abuse potential than Schedule II drugs, a category that includes most opioid analgesics. Among chronic pain patients taking opioids, the vast majority are on daily doses of 160 mg of oral morphine sulfate equivalent (MSE) or less. With seven dosage strengths up to 160 mg MSE, Belbuca offers a treatment choice for a wide range of opioid needs in chronic pain sufferers.

Oct 27, 2015 9:17 AM

Thanks for the info, Profiler!! It's definitely good to know. I'll have to ask my pain management doctor about it. I'm sure it's going to be very expensive and it will be difficult to get some insurance companies to cover it. When I was on Fentenyl Lollipops I did very well with them but I was in 1200mcg pops up to 10 a day and it was $15,000 a month!! The insurance company stopped covering them and now will only give them to cancer patients. Hopefully this will be different and helpful to those who don't get lasting relief from their pain with their current medications. I'm glad you're always on the prowl for new stuff, Profiler.. You're such an awesome guy!! Sending {{{Hugs}}} and prayers your way. I am so glad that you've been hanging around with us more.. No more disappearing for you!! You're needed (and wanted) here!💕🙏🏻🌻

Oct 27, 2015 2:38 PM

Profiler. I don't need to be a "negative Ned," but men should BEWARE. Buprenorphine drove my testosterone levels to that of a 95 year old man when I was 40. It took me 4 years to get it back to normal and stop taking testosterone.

My doc had me see a specialist to get off of a Fentanyl patch that wasn't working. Real dark experience with a happy ending (once I lose the remaining 25 lbs ... of the 40 I gained!)

I know it is a miracle drug for Heroine users. I hope it helps many of you too.

Oct 27, 2015 9:14 PM

Profiler, thanks for sharing. As I'm allergic to most pain meds everyone else is on, I doubt my pain doc would even try it. Good luck to others who use it! 🙏🌼

Oct 27, 2015 10:07 PM

Profiler thanks for the information on this new drug. How have you been doing? I haven't been on very regular since my granddaughter arrived in April. She keeps me on my toes every day lol.

Oct 27, 2015 10:45 PM

Basically this is suboxone with a different delivery system. The part that is scarey is this blocks opiods from attaching to thier receptors. Short version if you take this drug and have any type of acute injury say a car accident the drugs to make you stop hurting will NOT work. I had a patient on suboxone that did not let us know and we kept dumping pain medication into him and he was screaming in pain. Finally, he told us that he had been addicted to opiods then heroine and used suboxone to kick the habit. The moral to my story is if you take this make sure all of your health care team knows it and understands exactly how this drug works. This is just my two cents. Please just educate yourselves on the details. Stay safe my friends.

Oct 28, 2015 12:15 PM

I tried the bupe patch a few years ago when it was just being approved for chronic pain here. It was not effective for me. Like LMB says it is important (imperative in that case) to tell your doctors though I found most didn't know what it was. I had to get a colonoscopy and called before to discuss the sedation concern. The dr wasn't familiar with it, then thought it was only for addiction. She told me to stop three days prior to the procedure. I called the pain specialist who prescribed it and he said I could absolutely stay on it and just not to tell her. Unfortunately this illustrates the attitudes on either side that I've run into. As I was being wheeled into the procedure the dr asked if I took myself off of "whatever that stuff was" in front of the other patients, nurses and anesthesiologist, even though I'd called to prevent exactly this from occurring. I was duly shamed, the anasthesiogist expressed concern and I was 45 seconds away from the procedure. So I lied, because the bupe prescribing dr said I'd be alright. I was alright and the sedation worked, mercifully. Maybe it was medically morally reprehensible but frankly, that dr's was the most humane and helpful suggestion. He said it's dose dependent, meaning anasthesia or pain meds can still be used effectively in an emergency situation depending on how much you're taking. I was on a small enough amount and on the Rx with just bupenorphine. There are two formulas that I know of, that (subutex or bupenorphine) and subuxone (bupenorphine with a small amount of naltrexone added). The latter is more commonly used to treat addiction or people with history of addiction. Bupenorphine is somewhat similar to Tramadol in that it has a ceiling effect by itself, without the addition of naltrexone, and is a partial opiate agonist/antagonist. But it didn't feel druggy or heavy at all which would have been nice had it worked to relieve pain. I was also prescribed Vicodin for a root canal while I was on it, the dr said it wouldn't hurt to take it but it was pretty much like taking a Tylenol. I believe now that bupenorphine was partially responsible for some of my respiration problems during sleep and did see an article to support that a while ago. But the truth is no one really seems to know enough about it, even prescribers. The medicine does not feel as powerful as it is in that it does mess with the opiate receptors. That concerns me when it comes to chronic pain but I hear people do well with low dose naltrexone for pain so the whole thing is confusing. It wound up creating problems and questions that still can't be answered for me, though it seemed promising at the time. One dr said bupenorphine is a huge pharma conspiracy and he won't prescribe it at all anymore. I don't know about that but it is certainly not altogether benign. Personally I don't know anyone who has used bupe for pain effectively. I do know a few people who use the bupe/naltrexone combo for getting off of other opiates (for whatever reason) and are doing well with it.

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