Probuphine Implants: Impractical?

Probuphine

The more I learn about Probuphine, the less I think it will be practical for use in the average office-based opioid use disorder treatment setting. I predict it will be a specialty medication implanted by a few practitioners who take referrals from other doctors.

Braeburn Pharmaceuticals is sponsoring conferences for doctors to learn how to insert Probuphine, the form of buprenorphine that’s implanted under the skin like Norplant, the birth control medication. This medication is marketed by Titan Pharmaceuticals. Probuphine consists of four slender rods that are inserted just under the skin at the upper arm. These rods release buprenorphine over six months, when they have to be removed, and new rods implanted.

I wasn’t sure I wanted to do Probuphine implants, but I liked the idea of being able to do it, so I asked to attend one of their conferences to learn the procedure.

Alas, the company says only doctors who have performed minor surgical procedures over the past ninety days are eligible to learn to be an implanter of Probuphine. I can still prescribe it if I take the course, their letter says, but I’d have to refer to someone else to implant Probuphine.

Huh? I thought I could prescribe it already, since I have an “X” number. Maybe not.

If I can prescribe it but I can’t administer it, why would the patient see me at all? Why not just go directly to the doctor who can prescribe and implant?

I looked around the room during my recent addiction medicine conference and tried to imagine how many of these specialists had done surgical procedures over the past three months. There was one surgeon, and a few obstetricians, so I decided three out of sixty or so of the doctors who presently prescribe buprenorphine.

Even if the FDA approves Probuphine in May, I have a hard time imagining how Probuphine could be used in a typical office-based buprenorphine practice.

Because besides the implantation conundrum, who pays for it? Drug company representatives were unable to answer questions about the cost.

And how does the implant, the implanting physician, and the patient all arrive at the appointment time? Is the doctor expected to order the implant, store it in her office, and hope the patient shows up for the implantation? Surely we couldn’t give a prescription to the patient to take to a pharmacy for the implant, so I’m not sure how that’s going to work.

Won’t this medication need prior approval? Representatives from the drug’s manufacturer say “no,” but I have a hard time believing that.

I picture one or two sites in North Carolina that will have the resources to do the implants and probably keep them in stock, perhaps at a hospital pharmacy. Maybe the teaching hospitals will have the resources to do this.

Also, the Probuphine delivers drug levels equivalent to six to eight milligrams of sublingual buprenorphine, so patients at higher probably won’t be considered.

I’m starting to doubt the practicality of Probuphine at an average addiction medicine physician’s office.

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16 responses to this post.

  1. Posted by Theodore D Fifer MD FACS on April 29, 2016 at 2:37 pm

    Like my Daddy would say, ” All week wind, very little rain.”

    Reply

  2. Posted by andrew angelos on April 29, 2016 at 7:59 pm

    Correctional facilities could make use of this product I think. It could cut way down on the transfer of bupe inside these facilities also.

    Reply

  3. I couldn’t agree with you more on this….I received my call from the rep the other day and declined to currently become involved in this….I am a PCP who does no surgical procedures at all, no matter how “minor”. This requires a skill I don’t need or want to possess not to mention the OSHA requirements and cost of all of this for 6 to 8 mg of buprenorphine? Not even the standard dose of 12 to 16 mg daily. I don’t know. Maybe we are both wrong on this. Time will tell. I love your blogs. Keep them coming.

    Reply

  4. As an ER doc and an Addiction Medicine doc I feel comfortable doing the procedure. But with the inability to taper off the meds inherent in this product it becomes less appealing. I do have patients stable on 8mg/ day but I doubt they would pay out of pocket for this procedure when the medication costs them nothing currently and the office fee is minimal in comparison.

    Reply

  5. Hey, I take suboxone strips and my fiancé has the pills she ran out of her script early so I gave her some of mine. Now she got hers refilled and I’m now I’m out if I take her pills when I pee for my doc will they be able to tell I had to take hers and not the strips that I’m prescribed? I’m just worried if they see the difference in the two in my pee that the doc will drop me from the program. Thank you

    Reply

  6. Posted by Lois L. on June 1, 2016 at 12:49 pm

    The doctor doing the implant is required to purchase the implant and then seek reimbursement from the insurance company or directly from the patient if self-pay. The cost of the implant will be over $6000.

    The biggest advantage of the implant is that it creates additional barriers to diversion and misuse. However, prescribing information and REMS states that the implant is for stable patients on relatively low doses of buprenorphine which are exactly the type of patients who are less likely to divert buprenorphine in the first place.

    What about patients who are stable on lower doses of buprenorphine? Can they get one or two implants rather than four or five? Can the implant be left in for longer than six months to effect a gradual taper of the patients buprenorphine dosage?

    I am going to take the training next week. I do family medicine, and do minor procedures in my office, and did norplant in the past. Requiring physicians to have done minor surgical procedures in the office in the past 90 days is crazy. Anyone who did a surgical rotation in medical school should have enough background to place the implants.

    Reply

  7. Soon, I will be trying Probuphine. I’m currently stable on 4mg per day, I’ve been prescribed Suboxone for much longer than I’d like to admit. While Suboxone is very effective and I’ve never had a relapse, it would be nice to be free of the bupe “shackles” . I think Probuphine may offer a way to that goal.

    Probuphine may have some benefits that others forms of bupe don’t have. I’m thinking that if left in for longer than six months, it may keep working and offer a slow, controlled taper off of bupe. Of course, Titan will not say this is an option but its a risk I’m willing to take. I’ve talked this over with my doctor, he agrees that this may just work. He is willing to try, if it doesn’t work I will just go back on a lower dose of Suboxone.

    Reply

    • Just an update. I’m currently scheduled to receive the implant next Thursday! I’m excited and slightly nervous at the same time.

      My nervousness stems from hoping that the bupe will maintain steady blood level equal to the dose I’m currently taking. But if not “no pain, no gain” .

      I’m excited that I will no longer need to worry about a prescription every month, this severely limits my life at times. With work, vacations, and travel I always need to make sure I have enough Suboxone to last me. I’ve had this happen ( I suspect they were stolen from a coworker while traveling for work) its no fun! I’ve found I can last about four days before the WD’s slowly creep up on me, I stayed for a week, I had to fake the flu. Regardless, it’s something you just can’t tell the boss!

      Also, I look forward to the possibility that this implant may offer a linear decrease in drug over time. I have some hope that this may be the ticket to be bupe free.

      I will keep you updated!

      Reply

      • Ok, I promised to give an update after I received the implant. There was a delay in having the procedure, first due to a temporary shortage of the lidocaine/epinephrine anesthetic and then personal/professional commitments. Anyway, I had the procedure two weeks ago and I’m happy to report that so far Probuphine has exceeded my expectations in ways I didn’t even expect.

        I did a lot of research before deciding that the implant could be a better option for me than sublingual buprenorphine. I have a good relationship with my Suboxone doctor, I’ve never relapsed since I started many years ago, Suboxone really worked for me but it does have a few negative side effects and I don’t like being dependent on it. Even though I “stayed clean” the sublingual route is far from ideal, I could feel the bupe levels fluctuate throughout the day, even with splitting the dose. I’ve tried all sorts of dose levels and dosing regimes throughout the years and never could achieve a “steady state”. Some may say this phenomenon is a placebo type effect, I thought it could be as well but I can assure you it most definitely is not. Maybe its a metabolite type issue IDK, I just thought there had to be a better mousetrap.

        Several years ago I read that a company was developing a buprenorphine implant, it immediately struck me as the ideal delivery method. Technically it should be superior to sublingual and by design deliver a steady release of bupe. I was disappointed when I heard the FDA rejecting its approval.

        Fast forward to eight months ago and I was surprised when I found out the implant was approved. I met all the criteria that is recommended for its use I was the one who pitched the idea to my Suboxone doctor, he acknowledged that he was aware of the approval and surprisingly it seemed to piqued his interest. I wasn’t really optimistic that it would become a reality but after a few monthly check up appts. he asked me if I was serious about the implant and if so he was willing to prescribe it and do the procedure himself. I said yes, but I also asked if this could be used “off-label” as an easier, more controlled way to slowly wean off of bupe by leaving the implants in longer than the six month recommended replacement schedule. My thinking is that after six months the buprenorphine should decrease in a linear fashion instead of an exponential drop. It would be much easier than trying to decrease by cutting films to microscopic sizes. Lol! He thought my theory made sense and agreed to give it a try. He handed me a few forms to read and sign which got the ball rolling with my insurance and with the company which sells the implant. Braeburn (I think?) is who sells/markets Probuphine, they actually did all the footwork with my insurance. I did nothing but sign a few papers and receive a few phone calls. Luckily, I have decent insurance, I was approved and the implants were delivered to my doctor’s office.

        Since I did so much research I was a little nervous about the procedure. The obfuscator instrument that inserts the rods looked huge in some of the professional literature I read. But my self-induced anxiety turned out to be unwarranted, in real life its smaller than I thought. My doctor is equipped for procedures like this, he did the procedure in his office, only local anesthetic was used, all I felt was a little pressure and it was much quicker and easier than I thought. It was my doctors first time doing the implants and it took 15-20min tops. The pain and swelling were minimal after the lidocaine wore off, I didn’t even need Ibuprofen!

        I’ve read that the FDA was a little concerned that there will be a period of time(one-two weeks) between the implant procedure and the desired effectiveness of the implant. It was suggested for doctors to prescribe Suboxone to be a supplement if this occurs. My doctor was also aware of this, he told me if it becomes an issue he could always call a limited script into the pharmacy.

        For me, this “delayed release” concern was a non-issue. About six hours after receiving the implant is when I first noticed that it was releasing buprenorphine. It wasn’t too much nor was it too little and little has changed in the two weeks since then.

        So far, I will say my experience is that Probuphine is far superior to that of Suboxone. I feel it truly is a game changer. Just the steady delivery would make it worth it but there have been other positive changes. My mood has changed for the better, I used to be one grouchy, irritable, depressed f#@$r at times, now I feel more even-keeled. This is embarrassing to say but I can finally take a normal satisfying s#$t! Lol! Suboxone seemed to really screw up my bathroom habits, almost every time was an epic “struggle”.

        All these pale in comparison to biggest positive change I’ve noticed and that is my sleep. About a year after starting Suboxone I started having serious sleep issues. My wife tells me I started screaming, kicking and flailing my arms while sleeping, I actually gave her a bloody lip! She also said I would stop breathing. I would wake up absolutely exhausted but could not remember doing anything she described. It got so bad my wife kicked me out of the bed and I now sleep separately. I went in for a sleep test and was diagnosed with REM sleep disorder and severe sleep apnea. I’m actually in pretty good shape and am not overweight, my only other prescription is Pristiq, I never drink, smoke, or do any unprescribed/illegal drugs, the doctors had a hard time understanding the obstructive sleep apnea issue. The sleep issues were strange though because some nights were good, some bad. I could never pin down what caused the bad nights.

        I’m crossing my fingers, but ever since the implant my sleep has improved tremendously. I’m waking up refreshed for the first time in many years. Hopefully, it continues but I’ve never had a stretch of quality sleep last this long.

        One more thing, I’ve read some concerns from professionals that diversion could be an issue with the implants. I really can’t see this as a valid concern. I could not imagine someone being desperate enough to extract the rods to sell or to use themselves. In know, there are some wackos out there but that is just not an issue I can see happening often enough to be concerned about. Another issue is what will happen if, god forbid, someone with an implant needs emergency surgery/pain relief. I guess that’s a risk I have to take but I do keep a card in my wallet that will (hopefully!) alert doctors that I have the implants, I was also provided a medical necklace/bracelet tag for the same purpose. I will just use the wallet card.

        Sorry about the marathon post but I do think Probuphine is a game changer. If my experience so far stays the same I wouldn’t hesitate to recommend it.

      • Thank you for writing with your experience!!!
        Please keep us updated.

  8. Posted by Scott Bryan on February 26, 2017 at 10:47 pm

    I am getting the implant next week due to the fact that i qualified for their new patients assistance program. I am having a lot of trouble finding any testimonials online though and this has me a little anxious. I am currently on Bunavail 4.2 2x per day. So please, if anyone who has it would leave me a comment i would appreciate it.
    I guess at this point what i’m most concerned about is the psychological effect of not actually taking it… if that makes sense.
    I will comment more after I have it and give first hand support.

    Reply

  9. Posted by Scott Bryan on March 10, 2017 at 5:37 pm

    Update… I have been approved for the Probuphine pateints assistance program and was supposed to get the implant last week but of course there had to be a hiccup. Before sending out the kit they realized that my doctors DEA number doesn’t match the address of his new office and apparently that takes about 6 weeks to change. I have spoken to the receptionist at another office and she was able to speak shortly to her doctor. So far it looks like he will be willing to do it, but now he is going to have to fill out the paperwork to go to the patients assistance program. Hopefully this will all work out as I don’t have insurance (Florida doesn’t have expanded Medicaid) and I am currently applying for disability. I would love any feedback that anyone has concerning the implants effectiveness or the procedure itself.
    Thanks.

    Reply

  10. Posted by Corey P. on May 12, 2017 at 9:57 pm

    After weeks of going back and forth with my Dr.’s office, and unfortunately the way things are in this day and age, one has to do their OWN personal research and due diligence before undergoing any type of surgical procedure. One thing I was pretty sure of, and it was verified on the day of my procedure was that I was the first person to have the implant by my current Bupe Doctor. After weighing the idea of being a guinea pig, or continuing on my maintenance of Bupe in some form over these last six plus years, I decided to give it a shot.

    I am going to be completely honest here with this posting. Its been 10 days now since I had my procedure I take my sobriety from “getting high” very seriously, and its always been a mental struggle in dealing with what “other people” considered being “clean”. I saw that as one of the biggest benefits with this procedure. Its my decision if I tell people about it.

    From what was explained to me, six months was just a period of time they decided on in taking out the implants, and that they can last much longer. So, I’m going to be following up on this page, as I’m curious to find out from the guinea pigs before me if they continued treatment after their initial implants. Personally, I hope this isn’t a six month then six month treatment. But, I also know myself, and having had Bupe in my system for so many years has kept me out of harms way. Honestly, I’ve been thinking more and more about undergoing Ibogaine treatment at some time. Its been so long since I was in the “dope” game, that I’m truly frightened to live in a world w/o Bupe helping me get through each and every day. I can honestly say that while being on Bupe all of my cravings disappear. Getting high just never enters my brain.

    I guess I’m just curious about what happens next? I’ve read amazing things about Ibogaine, and I don’t trust the FDA or big Pharma for one minute. If Ibogaine is the cure, then it makes complete sense why its banned in the USA.

    Reply

    • Ibogaine is not an evidence-based treatment. Since it’s banned in the U.S., not enough research has been done in this country to know whether it works or not. Some limited data from overseas may exist, but not enough for me to endorse it as a realistic treatment.

      Reply

  11. Update #3: It’s been past the six-month mark with the Probuphine implant. My experience so far has literally been life-changing. I directly attribute it to the implant. In hindsight, I now realize Suboxone had some pretty severe side effects, mentally and physically. I was extremely moody/angry/depressed, my endocrine system was affected(low testerone), normal sleep was a total disaster (sleep lab confirmed severe sleep apnea along with a weird kicking/twitching sleep disorder), my immune system was also extremely compromised. I picked up every bug/cold there was, I even had chronic Giardia(a tenacious, disgusting intestinal parasite!), its a very rare occurrence where I live. My primary doc was dumbfounded, he actually thought I might have HIV/AIDS(!) because I was sick so often, thankfully the test came back negative. Ever since the implant, my health has rebounded to what I consider normal, IMO, this can be no coincidence. I feel the steady state delivery from the implant mitigates those negative effects. It could be possible that the naloxone in Suboxone created some of these issues but I seriously doubt it.

    I definitely do not miss the worry of losing or running out of Suboxone. I actually found some film strips while cleaning a few weeks ago, I just looked at them with indifference. No addict behavior of “yeah, I just hit the jackpot!”, I didn’t save them “for a rainy day”, I actually threw them out! That would have been impossible before. Another hind-site revelation has been that sublingual/transmucosal bupe still has a ritual aspect to it. The body/mind expects the drug, even though the half-life is long with bupe, you can still feel the dose swings and there is a “kick” after dosing. Ive tried all sorts of dosing regimes throughout my 10yrs on Suboxone and those dose swings were always there. I feel this prolongs part of the addictive behavior. Don’t get me wrong, I still am extremely thankful that Suboxone was available, never once did I “cheat” during my long relationship with it. Without it, I probably would have been in jail or dead, but now I feel there is “a better mousetrap” for the appropriate patient.

    As I expected the implant seems to have a linear dose taper. FDA advises six months for implant duration, I’ve passed the six-month mark and have not noticed any difference in its effectiveness. I plan to leave it in. I have high hopes for an easy taper, everything so far indicates this may be possible but as with everything else in life there is no such thing as a “free lunch”. It’s a hope for the best, expect the worst attitude. As one of the first to receive the implant, I’m in relatively uncharted territory. Only time will tell.

    Just an FYI, I’m an electrician, not a Braeburn shill but since I do have the Probuphine implant I check their website from time to time. I’m a nerd like that;) It now looks like they have another novel bupe based product about to be approved. It’s an injectable Buprenorphine “depot” There is a one week and a one-month version with different dose strengths. I think this will also be effective and easier for some docs to administer. I don’t think it requires surgical experience. It also seems diversion proof.

    Reply

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