Probuphine Update


About a month ago, the FDA accepted the re-submission of Probuphine, an implantable preparation of buprenorphine, for review. New Phase III studies apparently showed this form of buprenorphine to be “non-inferior” to existing products presently on the market.

As you may recall from my previous blog entry from May 21, 2013, Probuphine is an implantable form of buprenorphine that releases the medication over six months. The FDA rejected this form of buprenorphine in 2013 because the implanted rods impregnated with buprenorphine didn’t produce an adequate blood level of buprenorphine. The FDA also wanted more information about how physicians would be trained to implant the medication.

A double-blind, double-dummy phase 3 trial was completed in May of 2015 which apparently showed Probuphine did as well as the present sublingual buprenorphine products now available. I’ve searched the internet for this information but haven’t found the actual data. I’ve seen some information saying the Probuphine implant was compared to sublingual buprenorphine patients dosing at 8mg per day or less. If so, this would mean the company set the bar lower than the last study, when it was compared to patients on 16mg or less.

The process of Probuphine implantation may be cumbersome; doctors who wish to do this procedure must have a DATA 2000 waiver, and most of these doctors are not surgeons. Will general medicine doctor and psychiatrists presently prescribing buprenorphine want to learn this surgical procedure? I don’t know.

Unless the regulations are changed, if DATA 2000-waived physicians prefer to let surgeons implant the rods, we still must be physically present with the surgeon during both implantation, and explanation six months later. Will the patient’s insurance pay for the time and expertise of two doctors? I don’t see that happening.

What do I think about Probuphine? I think it’s an excellent method to reduce diversion. I think it would probably reduce opioid overdose deaths. However, I think it will make it more difficult to get patients to engage in the psychosocial counseling that’s so necessary for long-term change and recovery.

At present, the need to get new buprenorphine prescriptions keeps patients coming back to healthcare providers. We can, in a way, hold the prescription hostage until our patient engages in counseling. With an implantable form, we have no such leverage.

Probuphine could be an ideal treatment for incarcerated patients. If opioid-addicted patients are sent to jail, they could agree to have Probuphine implanted in order to reduce opioid craving and withdrawal symptoms. These patients would still need the psychosocial counseling for the treatment of addiction, but the Probuphine would be a humane comfort measure for these pateints.

If any of my readers have more information about Probuphine, please chime in.

And buprenorphine patients, what do you think about getting buprenorphine implanted every six months? Would this be something you’d be interested in, if it were covered by insurance?

10 responses to this post.

  1. Posted by William Taylor, MD on November 7, 2015 at 3:14 pm

    One issue that comes up all the time in buprenorphine treatment is how to handle acutely painful injuries, surgery, dentistry, and medical conditions such as kidney stones. Implantable buprenorphine is the product of developers with tunnel vision who see only the addiction and ignore the wide range of miseries that are part of the human condition.


  2. Posted by nspunx4 on November 7, 2015 at 7:58 pm

    Bad idea. What if your in an accident are EMTs going to be able to remove it to give you adequate relief in an ambulance? (I have the same issue with the naltrexone shot) What if u need a dose adjustment?

    This is my issue with buprenorphine as the new “miracle” first line treatment. its too easy to jump on and off and use when u want/can and jump back on buprenorphine when u need too. Methadone isn’t as easy to jump on and off.

    I see too many people who were on Suboxone and selling them on the side eventually end up at the methadone clinic in the end.

    No offense to those who use buprenorphine correctly and benefit from it. I support all types of MAR and harm reduction but nothing is perfect under the current system I see two types of diversion Suboxone (or its generic) and pain pills (including methadone pills prescribed for pain) I do not see OTP methadone on the market in either liquid or diskette form.


  3. In ten years, of using buprenorphine, we have, yet to have a patient opt for methadone. Conversely, we have had some patients who had a really tough time getting their methadone provider to cooperate with a realistic taper schedule that would allow us to start the patient on bupe.
    We have found that buprenorphine has significant positive effects as an anti-inflammatory medication and for its anti-cortisol properties. The vast majority of patients, admitting with a chronic pain condition, have used the full gamut of dilaudid, fentanyl, oxy etc. etc. and have begun to suffer negative symptoms, including not being able to control their pain. The bupe appears to be superior, for the vast majority of our legitimate pain patients.
    Regarding the possibility of being stuck in an intractable acute pain situation, like auto accident, kidney stones, procedures like an endoscopy and others, we find versed can help. ASAM gives some directives on the ER physician using a full agonist, in greater doses to come over the top. I’m sure that JanaBurson has more complete answers.
    While I do have some concerns about patients choosing the implant alone, we spend a large amount of time during the assessment process, explaining the nature of addiction, recovery and motivational counseling. Our retention rate, with prescribed buprenorphine has been in the 90% but, boy, it hurts when we spend all that time and sometimes pay for the physicians’ appt. and later having the patient abort the treatment process.


  4. Why not naltrexone orally- Have it paid for by private insurances for client’s that are out in the community and need it.


    • Because it doesn’t work.
      The problem is with compliance. Patients can “forget” to take it, then relapse. However, it could be helpful with a highly motivated patients, or a patient under intense monitoring, like recovering healthcare professionals, where if you don’t take naltrexone, you can’t go back to work.


  5. Posted by kevin on November 11, 2015 at 7:57 pm

    I wish they would come out with other drugs for opioid dependence other than just buprinorphine and methadone. We need other options.


    • Posted by Matt on November 14, 2015 at 5:11 pm

      As someone on buprenorphine (8 months), began at 16 mg and now i am on 6 mgs, i think this is a terrible idea. While it may be convenient for the patient, i think it will essentially convince people that so long as they have the probuphine implant inside them, that they are alright.
      I am so grateful for buprenorphine but it is NOT in anyway a cure-all. Addiction is a disease, and a disease of the mind, body and most importantly spirit. I know many addicts shun the 12 steps and meetings, but that is the only way i got my life back. Yes buprenorphine keeps me from craving opiates and ensures that if i do relapse, there will be no high.
      I really do love this blog and admire your commitment and expertise in the field of addiction. Many doctors still refuse to help addicts because of the strong stigma in this country. The real problem is the so called war on drugs, which is really a war on people.
      But back to the topic. Personally i would not trust any company to put a foreign object inside my body which then contains 80 mgs of buprenorphine, a highly potent opiod 25-80x stronger than morphine. What if something goes wrong and it all releases at once? What if it isn’t able to get my blood levels where they should be? What if i need pain management from an injury or accident? I have a hard time believing anyone in their right mind would want such a thing.
      I like being able to see a doctor once a month, it is a lot more than most people are able to get access to a medical professional, sadly.
      See i think the pharmaceutical companies believe that there products are the cure. I mean come on go and look at Reckitt’s website for suboxone. They paint such lovely pictures for the ugliest of diseases.
      On another note, i would not be one bit surprised if the government embraces this idea because it’s a great way to control the addict population…


      • I think you make many good points. If I were a patient, I might try an injection lasting a week, maybe even a month, but six months??? Let’s just say I wouldn’t want to be among the first patients to try it.

  6. Posted by Paul on November 16, 2015 at 3:12 am

    Sign me up. I am ready to be free of monthly visits. I love my doctor but I really don’t have the time to even see him every 3 months: I am lucky and am able to do urine screens and check ins with his OBOT nursing team but he likes to see his patients every 3 months. I have been on Bupernorphine since it came out in April 2003 and I have access to him on email anytime I have question. He was a ASAM past president and has a big role in developing public health policy in my state as a advocate for MAT patients I see him outside of his practice. I think this implant has a market in both compliant patients and the ones who keep diverting these medication this implant will save so many lives by keeping patients safe from our own bad decisions. This will keep the people screaming about diversion quiet.i know if I had a pain issue my doctor could figure out how to get over the Suboxone affinity to my mu receptors. They did it once before in a emergency surgery. I hope they get approval.



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