Suboxone Maker’s Petition Denied by FDA

Originally Posted 2/23/2013

I’ve written in detail about the bold move by Reckitt-Benckiser, maker of Suboxone, that few people outside the company saw coming.  In brief, the company has been cruising across the Atlantic for the past ten years, fueled by stellar growth of its flagship medication, even as the expiration of the patent on Suboxone loomed ahead (y’know– like an iceberg).

But unlike the Titanic, RB had a secret plan to deal with icebergs.  A couple months ago, the company hired a company that investigates bad drugs to look into its OWN product, Suboxone tabs, and used those findings to tell the FDA that the source of their profits for the past ten years is a BAD DRUG.  In fact, it is SO bad that they insisted on doing the right thing—file a Citizens Petition with the FDA to make sure that NOBODY ever makes that bad drug again.

By coincidence, RB happened to have a DIFFERENT drug with a fresh, new patent expiration date that they promised was much safer than the drug they used to make.  And by coincidence (insert more sarcasm), this all happened a year or so after the patent on the bad drug ran out, so RB was willing to just get rid of the bad drug completely.    Never mind that a bunch of other companies were about to make less-expensive generic forms of Suboxone; RB asked the FDA to protect the American people by banning those awful Suboxone tabs that used to make them so much money.

Urine Drug Testing on Suboxone

First Posted 2/15/2013

A recent exchange with a reader:

I have been on buprenorphine for 5 yrs.  Recently my doctor stated that my u/a t looked like I have been ‘loading my meds.’  He said my levels where ‘backwards’ and that would happen if I took just a few doses just before my appt.   My doc had me come back in two weeks to go over my next u/a, and again it came back funky.  So my doc starts having me take my meds in front of the nurses on a daily basis.  Two weeks later with supervised u/a’s, my urine comes back the same.  My doc looked perplexed but kind of ignored the results like I was still doing something to mess with the results.  I had to come in again for another urine test and it finally came back normal.  My numbers were fine after that, and all was good until last week.

I went to my normal monthly check up and the u/a showed NO buprenorphine in my system.  My doc looked at me like I am the biggest liar.  I am perplexed.  I am taking my meds daily.  I don’t know what is going on and I need to figure it out soon before my doc kicks me out of the program. What could be wrong with the test, that is says that I have no buprenorphine in my body?

Wasting Resources on Suboxone

Originally posted 1/26/2013

Readers of this blog know that I have often questioned whether there is any clinical difference between Suboxone and generic buprenorphine.  Naloxone is an opioid-blocking chemical added to buprenorphine, supposedly in order to reduce intravenous diversion of the medication.  The combination of buprenorphine plus naloxone is branded as Suboxone. I’ve pointed out over the years that the high affinity of buprenorphine at the opioid receptor is too great to be overcome by the amount of naloxone in a tablet or two of Suboxone, making naloxone unnecessary for anything except to create profits from Suboxone.

Because of the low number of doctors who obtain certification to prescribe buprenorphine and the limits on number of patients per doctor, many people who want treatment with buprenorphine are unable to find it.  While sitting on wait lists, some people opt to treat themselves with ‘street Suboxone, rather than continue to use oxycodone or heroin.

When taken through the proper sublingual route, about 25-33% of the buprenorphine in Suboxone reaches the bloodstream.  Because of the scarcity and high cost of Suboxone, patients who engage in self-treatment sometimes choose to inject the medication, since doing so reduces their costs by 70%.

I have treated patients who described injecting buprenorphine or Suboxone while waiting for a treatment spot to open up.  The patients always claim the same thing; that they could detect no difference between injecting Suboxone, with the medication’s naloxone component, vs. injecting plain buprenorphine.

Questions and Answers about Opioid Dependence and Buprenorphine