Medication with Lower Abuse Potential Now Available

Medication with Lower Abuse Potential Now Available

By Ed Coghlan

As federal scrutiny over opioid abuse continues to accelerate, news this week that an alternative is commercially available.

BioDelivery Sciences International, Inc. (BDSI) announced the commercial availability of 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™, distributed and promoted by Endo Pharmaceuticals, is now available nationwide.

“BELBUCA is particularly important since it provides an important new alternative for the millions of individuals who suffer from chronic pain,” said Dr. Mark Sirgo, CEO of BioDelivery Sciences.

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.

“BELBUCA is a very important product to BDSI, as well as to our partner Endo, who has a significant presence in pain and who is committing significant resources to support the launch of BELBUCA. We believe BELBUCA is in excellent hands and we look forward to its future growth,” said Dr. Sirgo.

The U.S. Food and Drug Administration (FDA) approval of BELBUCA was based on data from two placebo-controlled, randomized Phase 3 studies showing that BELBUCA™ provided significant improvement in patient-reported pain relief with a low incidence of typical opioid-like side effects. BELBUCA™ is available in seven dosage strengths for flexible dosing from 75 μg to 900 μg every 12 hours, allowing physicians to titrate BELBUCA™ individually for patients to a tolerable dose that provides adequate analgesia with minimal side effects.

BEMA Technology

BEMA Technology

BELBUCA™ is a mu-opioid receptor partial agonist and a potent analgesic with a long duration of action that utilizes BDSI’s BioErodible MucoAdhesive (BEMA®) drug delivery technology. 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 oral MSE, BELBUCA™ offers a treatment choice for a wide range of opioid needs in chronic pain sufferers.

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Authored by: Ed Coghlan

There are 21 comments for this article
  1. daniel at 10:44 am

    i would say this is great news. what many commenters are forgetting is that suboxone had not yet been approved for pain. only addiction. if you get a buprenorphin from your dr, then it’s ‘off label use’. Why the dosage is different is because it’s transdermal. medicinces go into your body different ways and they are broken down or delivered in different ways. For example, much less opiods are required upon iv then when orally administered. I am a chronic pain patient who has had great, wonderful success with suboxone. it’s not for acute pain. it’s only for chronic pain. I’ve gotten down to about 5 mg a day. side effects are minimal. I don’t have sleep apnea any more….i feel normal. i’m really scared about what’s happening right now with opiods in our country. There needs to be more medicine like this and they need to have super aggressive, capatilistic approaches if they are to work in this system and get to us in time.

  2. June at 5:35 pm

    I tried Belbuca!!! I don’t understand how it can treat chronic pain when the dose of Buprenorphine in the films are so low that I would have to take 10 900mcgs films to be equivalent to my regular dose of 2 8 mg Subutex! When my insurance would not pay for Subutex any longer they are way more expensive! And don’t work well! They leave a gummy substance in your mouth that will not disolve! I don’t recommend it for chronic pain!

  3. Lisa at 12:30 pm

    I was taking 2 8mgs subutex a day for my pain!! My insurance would no longer pay for Subutex, so they switched me to Belbuca! 2 900mcgs a day! What does that compare too to two 8mgs of Subutex! The Belbuca is making me have headaches and nauseas ! I don’t understand why my insurance will pay for Belbuca and not Subutex! Belbuca is so much more expensive!

  4. Renee Dribard at 8:39 pm

    I am a chronic pain patient that could not find a doctor to prescribe me any opiates after my doctor retired. I was on methadone and knew it worked for me. I called a methadone clinic as I was willing to go that far for relief. After telling the truth, that I wanted to come there to treat my chronic pain, I was denied admittance. I went to another clinic this time not telling them it was for pain and not addiction. Instead of methadone I was prescribed subutex “for my addiction /pain control ” because they were moving in the direction away from daily doses and subutex can be prescribed one month at a time. It does very little for my pain. I have experienced blatant discrimination trying to get this medication filled at pharmacies. Subutex is not approved for pain control although the active ingredient is the same as this drug and Butrans. It makes absolutely no sense except as stated above the almighty dollar is in control.

  5. Sandy at 8:26 pm

    Today I asked my pharmacist about this not-so-new medication to treat pain, and he looked at me with extremely skeptical eyes as if to imply that it was being recommended to treat an addiction. He then adamantly replied that there are much better options to treat severe chronic pain. At the end of the day are we not at the mercy of our pain doctors for what they are willing to order?

  6. Alvin Hill at 2:40 pm

    Well said, Jean Price, and right on the money. Between greedy, unscrupulous pharmaceutical companies aiming to maximize profit, and fanatical, dishonest government agencies, determined to make opioid medications unavailable, it’s hard to determine whom to trust. The safest answer is probably no one!

    No, Kristine, you’re not out of touch; you’re absolutely correct. These people care about pain patients as sincerely as foxes care about chickens.

  7. Brooke at 1:45 pm

    It cracks me up how many pharmaceutical companies are dressing up Suboxone (buprenorphine) in different delivery forms and flavors to make more money. It is all the same and has been around for decades. Buprenorphine has no proven studies showing it works well on severe pain or all pain conditions but pain doctors are ripping many patients off their opioid regimen and claiming miracles with this. Yes, it is a great alternative pain med for some and is good for opioid withdrawal but the way the companies repackage and continue to hype it up for huge profits is criminal. Our FDA will approve anything these days. Subutex, Zubsolv, Bunavail, and now Belbuca are just derivatives of Suboxone but with ever-increasing price tags and copays.

  8. Jean Price at 10:43 am

    I think this will have the same repercussions patients who try methadone for pain are having…labeling of abuse rather than chronic pain. Actually chronic pain has almost become a non entity in the medical community! It has morphed into being chronic drug/opiate use!! So, a not new drug, used primarily to treat addicts is now being touted as a wonderful medication for chronic pain! Does this seem like nonsense to anyone? It does to me!

  9. BL at 9:15 am

    Everyone that is asked to take this needs to remember that it may impact how they are treated for pain in the future and that they may not be able to find a dr that will treat their pain after taking buprenorphine. Not all drs are as well versed with the different meds and uses as the pharmaceutical companies and the politicians want us to believe they are.

    Below is a comment from the National Pain Report’s President Recognizes the Need for Opioids for Pain Sufferers. Suboxone isn’t identical to this drug because it has a combination of buprenorphine and naloxone, but both are used to treat addicts. The dosages are different for addicts and chronic pain patients, but again not all drs are well aquainted with both of these meds for chronic pain.

    “Carolyn N
    February 25, 2016 at 7:41 pm
    I’m a terminally ill cancer patient and I’m being refused pain medication for the chronic debilitating pain I go through day and night. I’ve thought about suicide to end it faster. No one that feels pain the way I do would be able to live this way. I see an oncologist at the university of ky and I’m told to take ibuprofen for pain. I take 10-20 pills at 200mg each every 3-4 hours. What is wrong with these doctors and why do I have to suffer what time I have left in pain like this I stead of spending it with my kids and granddaughter? I’m not nor have I ever been on drugs or addicted. I was given suboxone for back pain 4 yrs ago and now I’m labeled as a drug abuser. I had no clue about suboxone or did I ever hear about it before being prescribed it by a dr. Now terminally ill and treated bad by any dr that reads my medical records. Hard telling what types of things are said about me that are not true in there.”

    http://nationalpainreport.com/president-recognizes-the-need-for-opioids-for-pain-sufferers-8829652.html#comments

  10. April at 10:29 pm

    I have been on Buprenorphine for years for my pain, and I personally love it. Now, I do think that Belbuca dosage is still too low, although it’s much better than the Butrans patch,which at the most was 20mcg. Buprenorphine can be very effective for not only pain,but for its antidepressant effects, and it is used (off-label) as such. I grew tired of the never-ending opiate tolerance hassle, Buprenorphine is very long-lasting, so that I don’t feel like I’m “on something, ” but rather feel “normal ” with descent pain control. I hope Dr.s ,family doctors, are willing to prescribe this,without having to go to pain management.

  11. Carrie at 9:21 am

    I am with the previous posters here, all have VERY valid points, increased costs, Stigma of being on medication DESIGNED FOR ADDICTION TREATMENT, this doesn’t fit IN the opiate receptors, just acts like a piece of tape over a key hole. Each different for of opiate medications fit into the receptors slightly different, giving pain relief in a somewhat different manner. I have had GREAT success with 1 opiate as extended release, and 2 different types of opiates for breakthrough. Together they help me with the different aspects of the pain, allowing some quality of life. Why would I believe that the best NEW treatment doesn’t even actually go IN the receptors?

  12. Theresa at 7:54 am

    Is this drug stronger than dilaudid or exalgo. I have RSD-CRPS in both hands and arms. Not getting enough pain relief to have an okay quality of life. Any thoughts?

  13. Sandy DeWys at 1:57 am

    Does it have the same glue as the morphine patch ? Some of us are allergic to the glue or that ever makes it stick !

  14. Sandy at 5:54 pm

    I read somewhere recently that Buprenorphine is meant for patients with moderate levels of chronic pain. It is not meant for us folks with extreme levels of severe round the clock chronic pain and CRPS. And this same report noted that you must be off all opioids for several days before you can start on this med. Good luck trying to manage your pain w/o a strong opioid during the transition, not to mention the harsh withdrawal while weaning off.
    Drug companies may convince doctors Buprenephrone is effective, but I for one am not willing to give it a try, especially when methadone is doing the job just fine and has been for some time.

  15. Alvin Hill at 3:33 pm

    When buprenorphine first appeared decades ago, it was touted enthusiastically as the ultimate answer for chronic pain treatment, potent, yet non-addictive, an ideal drug. Yet nothing came of those predictions. Why not? Addiction treatment clinics apparently find the drug useful for “detoxifying” patients who want to be weaned off opioid medications, and initial clinical trials of buprenorphine as the primary or sole drug for long term pain management seemed promising, but in some cases it also caused troubling side effects, including some not seen with conventional opioid therapy. Nausea, vomiting, constipation, and headaches are apparently rather common and often severe. Unusual side effects included lower leg edema, “intractable” headache, and subjective breathing difficulty (or “discomfort”).
    Why has buprenorphine not enjoyed greater success as a substitute for conventional (especially high dose) opioid pain management? Is this due merely to clinicians’ lack of comfort with such an unfamiliar type of medication? Do the frequency and severity of GI side effects impair its utility? What about the headaches and the discomfort that patients report with respiration ?
    Further clinical studies are clearly indicated. Like many new therapies, this one may offer significant advantage for some, but not all patients.

  16. Dr. Dan Carpenter at 2:38 pm

    This doesn’t sound new. I’ve been using it’s competitor, Suboxone, for years. The hype doesn’t even mention Suboxone or compare the two. This press release is just ADVERTISING for a well known (and effective) medication that now is being distributed by another company and given a new name. Suboxone is available in a film, or sublingual tablet. For whatever reason, I found that the dissolving film style stained the edges of my teeth brown, adjacent to the gums. It was easily scraped off by the dental hygienist but it made me switch to the pill form.

  17. Kirby Accardo at 2:19 pm

    This is just another company producing what’s already available. We need real solutions to pain. Some of us are on higher than 160 MG of morphine. I tried Buprenorphine and thought I was dying. No one told me the dosages where so different. I spent 5 days in hell before I gave up and went back to morphine sulfate. Come on Endo Pharmaceutical gives us a real drug that can control real pain.

  18. HJ at 12:55 pm

    Yes, this isn’t new. It’s a new delivery method.

    Let me tell you what happened with asthma inhalers and why things like this are potentially a bad sign.

    So, asthma inhalers used to be available as generics. These life-saving drugs were affordable.

    However, they contained CFC’s (chloroflorocarbons) in their propellant (which allows you to inhale the drug). CFC’s are harmful to the ozone layer.

    But… are there really enough asthmatics using inhalers that CFCs from them are going to destroy the ozone layer? How does it compare to other potential sources of CFCs?

    Now, what I heard is that the issue was going to be put aside, but it was the DRUG companies that lobbied for CFC-free inhalers to be the only inhalers allowed on the market. I don’t know for a fact that it’s true, but I believe it’s very likely. Why?

    The drug companies re-patented the NEW CFC-free inhalers so no generics could be made available until patent runs out. I have checked to see when patents on Pro-Air will run out and they SHOULD have run out already. But due to the complexities of patent law, they may still be protected… but it’s not clear how long. (Why is patent law so complex that there’s no clear answer on when a generic will be available?!?)

    All inhalers… all life-saving inhalers… are now brand name only. My $10 script is now $70 per inhaler. For each of my inhalers.

    So, folks, welcome to the obliging pharmaceutical companies who are more than willing to sell you the same drug in a different delivery system so that the availability of the generic is delayed. And doctors? They’ll be “protecting themselves” because they’re not prescribing pills. They’re prescribing a different format of the drug that’s MARKETED as being new, different, and without the addiction potential.

    And you’ll be forced to pay… what? 7 times as much or more? If insurance covers it as a preferred brand drug.

    Is it safer than the suboxone pill? I wonder if the company had to do a study on that or if they didn’t bother. It really wouldn’t be in their best interests. Because they can sell you this film you put in your mouth for MORE than the pill costs. Even if the pill is already or will be available as a generic, the film version of the drug is MARKETED as safe!

  19. BL at 12:15 pm

    I understand that the dose for chronic pain is not the same dose that they use to treat addiction to opiates, but I have great concerns about this drug. It seems like chronic pain patients are going to be treated like drug addicts period. I also don’t like that they are misrepresenting the truth in their advertising saying that this is a new drug. Can you imagine family members and friends, not to mention employers, that aren’t aware of the lower dosages are used for chronic pain and thinking that the person that is taking this is an addict ?

    Buprenorphine-
    http://www.samhsa.gov/medication-assisted-treatment/treatment/buprenorphine

  20. Nancy R at 11:04 am

    I would try it. Do you have to withdraw off opioids first? It’s the same as suboxone without the naloxone (?sp). Has anyone used buprenorphine for pain?
    I wonder when it would be available and if my pain center would prescribe it. I like the long acting as you would only take it 2xday.

  21. Kristine (Krissy) at 10:20 am

    Why is this touted as a New Drug? Just to get the company publicity? That’s ok, but here we go again…education is so far behind the amount and types of drugs available, I see it as a big problem. Those of us in this circle have knowledge and are self-educated to some degree, but what about the general public? And what about new pain patients? There has to be a ton of confusion out there unless I’m the one who is out of touch.