Indra Cidambi, M.D.

Sure Recovery

Why Probuphine Will Flop

Cons of FDA Approval of Probuphine

Posted Jun 01, 2016

Although the Food & Drug Administration (FDA) recently announced its approval of Probuphine, I believe there are a number of formidable hurdles that will severely limit its adoption. An implantable form of buprenorphine, Probuphine is a medication used to treat opiate addiction by reducing cravings and withdrawal symptoms. Probuphine offers important benefits not currently provided by other forms of buprenorphine. For example, since Probuphine is in implantable form, the medication is gradually released into the blood stream, helping medication compliance. However, while Probuphine has the ability to help individuals seeking longer-term treatment for Opiate Use Disorder, the processes related to dispensation makes it impractical.

Here are some of the reasons I believe Probuphine will flop:

  1. Efficacy Is Not A Given: Probuphine is recommended for people requiring 8mg of buprenorphine or less a day. If this dosage proves to be less than one needs, it’s possible that an individual in recovery may seek opiates on the streets in order to satisfy cravings or avoid withdrawal. Also, Probuphine could potentially ‘incentivize’ patients to not attend counseling. Probuphine only requires patients to see their doctor once every six months, a practice that may inhibit their recovery and allow them to ignore the lifestyle changes needed to change their ways. I have found through my work at the Center for Network Therapy that it is not enough for an addict to rely solely on medication while on the road to recovery.
  2. Co-Abuse of “Benzos” Could Prove Dangerous: If individuals implanted with Probuphine co-abuse other classes of drugs, such as benzodiazepines, the effect is the same as using opiates and benzodizapines together – i.e. increased risk of respiratory depression. Perhaps this would be discounted, if it were not for that fact that recent research has found that between the years of 2000 to 2010, co-abuse of benzodiazepines and opiates has increased by 570%. Use of alcohol while on Probuphine (Buprenorphine) is also contraindicated. If these individuals implanted with Probuphine do not participate in counseling, they are unlikely to be monitored for abuse of other substances, a possibility with dangerous consequences.
  3. Prescribers Lack Surgical Skills: Probuphine requires a physician with some level of surgical skill to implant the medication under the skin. Currently family/general practitioners, Doctors of Osteopathy, internists and psychiatrists write nearly three-fourths of buprenorphine prescriptions, and only a small percent of the targeted medication is prescribed by doctors with training in surgery. While Probuphine’s manufacturer expects doctors prescribing buprenorphine to undergo training to learn to implant Probuphine, it is hard to envision this happening.
  4. Divided Care Cumbersome: If enough current prescribers of Buprenorphine do not participate in the Probuphine implant program (even if they do participate in the prescriber program), the result would be divided care. In that scenario, the prescriber (likely an addiction specialist) would have to be present when the surgeon (or equivalent) performs the procedure, a situation prime for logistical headaches. Also, who is responsible for the patient? The doctor who prescribes the medication or the doctor who implants it? Who provides follow-up care? These are questions everyone should be asking themselves.
  5. Implant Removal Difficult: A study showed that only seven out of 15 specialists who participated in the trial were able to successfully remove all four implants. The other eight merely followed ‘proper procedure.’ What this means is that the eight unable to remove the implants followed the recommended course of action when they were unable to take the implants out. In this test, the reason cited for being unable to remove the implants was that the implant was not palpable (the physician could not feel the implant through the skin). In order to locate the implant, physicians would have to send the patient for imaging, a time consuming and unwieldy process.
  6. Unpalatable Accountability: Probuphine is to be distributed under a ‘closed distribution system,’ which means that the manufacturer will ship the product directly to buprenorphine providers trained to implant the drug. The providers would be required to store the medication (a controlled substance) in their offices and then implement an inventory and accounting system for the controlled substance. The responsibility of storing the medication and additional paperwork attached to the distribution of a controlled substances will be a strong deterrent to providers supplying the implant.

While Probuphine (implantable form of buprenorphine) has many advantages, I believe the many challenges outlined above will serve to severely limit the uptake of the medication in the market. Potential prescribers have to jump through numerous hurdles and potential patients may not be receive the desired efficacy. Consequently, it is my belief that another iteration, which addresses these challenges will be required before the medication takes off and people start truly benefitting from it..