Probuphine Update

probuphine

Sorry it’s been some time since my last post; I broke my leg, had to have surgery, and only recently got out of the hospital. How’d I break my leg, you ask? Ah, I had a little trouble sticking the landing of that double axel…ok that’s not true…I broke it walking the dog.

And here is an update regarding the latest on Probuphine…

Probuphine, a new implantable form of buprenorphine, was not approved by the FDA, despite a recent recommendation by the FDA’s advisory committee to approve this new form of buprenorphine. This drug is better known under the brand name of the sublingual form, Suboxone.

According to last week’s Alcoholism and Drug Abuse Weekly, Titan Pharmaceuticals, maker of Probuphine, was told by the FDA they needed more information to show that Probuphine provided adequate opioid blockade , and they needed to show the effects of a higher dose of Probuphine. According to studies, the present formulation of Probuphine gave a lower buprenorphine blood level than compared to the sublingual form dosed at 16mg per day. The FDA asked for testing of the training that’s planned to be given to physicians who implant and remove the Probuphine cylinders.

I was quoted in the article; as I stated in an earlier blog entry, I think the present formulation of Probuphine under-dosed patients in Titan’s study. I think it should be re-formulated so that more medication is released per cylinder. Patients switching from sublingual could have their Probuphine dose varied according to how many cylinders are implanted. I also criticized the complicated procedure for both implantation and explantation. Doctors with Suboxone waivers can store the cylinders in their offices, but we’d have to assure security of the substance and keep records for the DEA. We would also have to be present with the surgeon during implantation and explantation, which is not financially practical for me, at least. Some Suboxone doctors may decide they want to learn to do the implants themselves.

I see a possible area for use of Probuphine in incarcerated opioid addicts. Prison systems say they don’t want to try to dose inmates with a controlled substance, because of diversion fears. With Probuphine, there’s less risk of diversion, and inmates’ opioid addictions could be treated with Probuphine implantation every six months. This may not give ideal blood levels, but it’s far better than letting a person with opioid addiction endure opioid withdrawal while incarcerated, which does nothing to help the underlying disorder. These people would still need psychosocial addiction treatment, though.

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13 responses to this post.

  1. Posted by Icecutter on May 21, 2013 at 5:45 pm

    What about when people with the Probuphine implants need serious pain relief? Such as in surgery or accident trauma? Since buprenorphine (as Probuphine) is a partial agonist, meaning it has some antagonist quality, does that mean that users of the implants would not get adequate pain relief due to the blocking effect? In people using the films (Suboxone)the buprenorphine would wear off in a day, but with implants, that blockade effect would persist. What can you tell us as this concern of potential Probuphine users?

    Reply

    • That is an excellent question and a legitimate concern. Pain control for people on buprenorphine has been talked about quite a lot at addiction medicine meetings. One school of thought says that the opioid receptors would never be 100% occupied so that pain control can be achieved with high enough dose of an opioid like fentanyl. However, in the real world…ER docs maybe aren’t as familiar with buprenorphine as they should be, and may balk at giving high doses of a powerful opioid to someone who is on a medication for the treatment of opioid addiction. I call doctors these doctors and they sometimes get nasty with me – just imagine how they would react to the addict telling them to please increase the fentanyl dose to get around the buprenorphine blockade.
      Plus, several anesthesiologists that I know say that it’s difficult to over-ride that opioid blockage produced by buprenorphine in some patients. So yes, if I had a Probuphine implant and then got into a car wreck, I’d be worried…
      I think we don’t know enough yet about all of the different types and subtypes of opioid receptors. One person may be genetically made to have more of this type receptor than that one, and respond differently to different opioids.

      Reply

      • Very true!! In west tn : most drs nor pharmacist that work in a hospital setting know what to do with a subutex patient! When I had a c section/ it took two pharmacists and an anesthesiologist to come up with a “killer dose” of fentnyl! Checked vitals every hour bc were scared that I would stop breathing. The claimed they have never seen such as this!

        My best advice to anyone on subutex and is pregnant ……be honest with your drs so they can research your medication and check your baby closer than normal. don’t abuse, and contact hospital before surgery. It took me having to get my sub dr to call my OB dr the second child I had: to make sure adequate pain medicine was given after birth.

        My first c section consisted of only subutex for pain (my subutex….SL)- they wouldn’t give anything else!! Horror story that I hope many will never have to go thru!

        Thanku for all the educational blogs!!!

      • That’s awful. Yes, all pregnant women should make sure the Suboxone doc talks with the OB, to explain the usual way of managing pain. The suboxone likely won’t be enough, at least for a C/S. Sometimes I talk with an obstinate OB who still refuses to prescribe pain meds. And if I were that doctor’s patient I’d find a new doctor. This needs to be discussed far in advance of delivery, so everyone follows the same plan.

  2. Posted by kevin on May 21, 2013 at 6:56 pm

    Hope u have a fast recovery. That has to be painful.

    Reply

  3. Posted by db312 on May 21, 2013 at 8:34 pm

    Interesting. I hadn’t heard of this. As far as providing treatment to prisoners. I doubt that’s going to happen, except in some very liberal leaning regions maybe. Generally, the idea that people will suffer in prison is OK with most of the population.

    Reply

    • Sadly, you are probably right. What’s that saying about the greatest measure of a civilization being how it treats its weakest members?

      Reply

  4. Posted by Joy Auren on May 22, 2013 at 10:07 am

    So sorry to hear about your leg! That dog walking is dangerous stuff! 🙂 So glad to hear your on the mend! Your in our thoughts and prayers

    Reply

  5. Posted by Jon-eric Baillie, M.D. on May 22, 2013 at 5:01 pm

    Where can I get some instruction on the safe and proper method to insert probuphine rods?

    Reply

    • From titan Pharmaceuticals. I’d check their website for some contact info. I doubt they will be authorized to give trainings until after the FDA approves the medication, though.

      Reply

  6. Posted by Alan Wartenberg MD on May 10, 2016 at 4:24 pm

    I have signed up to take their course, but didn’t see anything in their registration information that indicated that I had to have minor surgical treatment experience prior to the training. It would seem that since each implant is the equivalent of a 4 mg daily buprenorphine dose that being flexible on the number of implants would allow reasonable choices to be made. Clearly, it would seem to me that this treatment should be indicated (like other very long acting opioids) for people ALREADY titrated to a stable dose, particularly when there may be concerns about diversion. It would be of particular concern if the individual had a precipitated withdrawal, particularly if the implants were not known to the treating physicians. Have already seen one case of a naltrexone implant that caused this resulting in an ICU state, renal failure and the need for temporary dialysis (not to mention a great deal of grief for patient/family and treaters.

    Reply

    • Wow, that’s awful. I would think the physician doing the naloxone implant would do at least one day or oral naltrexone to assure no prolonged withdrawal would be precipitated.
      I think in the proposed prescribing information it is recommended to induce the patient on sublingual buprenorphine, then do the implants.
      As I understood it, and I may be wrong, the implant comes as a set of four rods, and I don’t have the impression that the number of rods can be changed according to expected patient need.
      Please let us know if they don’t require you to have surgical training. I was called by a Probuphine rep that was arranging a time and date for me to join a class when she said I could always take the course, just couldn’t do the implants in real life if I had not had minor surgical experience in the last three months. I said if I can’t do the implants then I’m not likely gonna waste my time traveling to take a course on how to do it.

      Reply

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