Posts Tagged ‘long-acting buprenorphine’

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?