Suboxone, the Blockbuster Drug: Now 28th Highest in Retail Sales

aasub

In a report issued in December, 2012 by the Center for Substance Abuse Research of the University of Maryland, Suboxone, the name brand of the medication buprenorphine) now ranks as 28th   highest for total retail sales among all prescription medications. This center says retail sales of Suboxone will reach $1.4 billion dollars for 2012. This is up from an estimated $137.1 million dollars in 2006.

Why has Suboxone reached such blockbuster status? Obviously, people with opioid addiction are entering into treatment, unless doctors are prescribing in for pain off-label. Many patients with opioid addiction are new to treatment, but I think some patients of methadone clinics are changing from the stronger, more tightly regulated methadone to Suboxone. Methadone is the only other opioid-agonist medication approved by the FDA and DEA to treat opioid addiction. Since Suboxone, unlike methadone, can be prescribed by a doctor in an office setting, it’s more appealing to many people seeking addiction treatment.

The report postulated that use by opioid treatment centers was responsible for some of the increase in Suboxone sales, but I question that. The brand name Suboxone is currently about twice the cost of generic buprenorphine tablets. Opioid treatment programs, which pay pennies per dose for wholesale methadone, use most of the fees from methadone patients to pay their counselors, nurses and doctors. If they use the more expensive name-brand Suboxone, their profit margin plummets, unless they raise treatment fees dramatically.

Some treatment centers, like the two I work for, already make buprenorphine, the generic for the name brand drug Subutex, available as a safer alternative to methadone. However, some centers may be reluctant to use the generic, since theoretically it is more likely to be abused by addicts intent on misusing buprenorphine by injecting or snorting. At present, there is no generic available that also contains the naloxone that Suboxone has in it. This substance isn’t absorbed when appropriately used under the tongue, but puts most opioid addicts into withdrawal when injected.

Obviously, two factors determine the amount of retail sales for medications: the number of units sold and the price per unit. A look at the top ten medications in retail sales shows that half are costly new drugs to treat immunologic diseases, HIV, and cancers: Humira, Embrel, Remicade, Copaxone, and Neulasta. The amount of these medications sold isn’t great, but the expenses are.

Surprisingly, the top medication in sales is Nexium, for which there’s a cheaper generic available over the counter (omeprazole). Hats off to the Nexium sales force, I say. Well played.

Second, third and fourth are Abilify (treats depression and bipolar disorder), Crestor (for high cholesterol), and Cymbalta (treats depression, also some types of chronic pain).

The only medication with addictive potential in the top 20 is OxyContin, at number 13.

I’m still trying to decide what this information about Suboxone sales means. Of course I hope it means more addicts are getting appropriate treatment. I hope it does not mean the cost of Suboxone is rising, or that Suboxone is being inappropriately or indiscriminately prescribed.

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4 responses to this post.

  1. Posted by tpd on January 19, 2013 at 8:35 pm

    I’m curious, in reference to your statement, “At present, there is no generic available that also contains the naloxone that Suboxone has in it. This substance isn’t absorbed when appropriately used under the tongue, but puts most opioid addicts into withdrawal when injected.”

    Where did this idea that the combination of buprenorphine plus naloxone prevents or deters intranasal or IM/IV “miss-use?” Compared to just buprenorphine alone I mean. Are there some studies out there that demonstrate such an outcome?

    I ask all this because, as I have first hand experience of when I originally switched from using full agonists to buprenorphine (exclusively in the form of Suboxone tablets) in my own addiction’s active early phase. And I have much more direct second hand experiences, garnered by working closely with individual addicts prescribed Subutex and Suboxone. All of the feedback I’ve heard, as well as my own experiences, point to the rule that the combination of buprenorphine and naloxone, compared to just buprenorphine alone, makes no to little difference in effects, regardless of ROA.

    Sorry, that was something of a run on sentence… Anyways, the point of all this is to posit the claim that, due to their relative affinities to opioid receptors, buprenorphine essentially “out competes” the naloxone. This is actually similar for the same reason for how a “blocking dosage” of Subutex or Suboxone (i.e. buprenorphine +/- whatever full antagonist, as long as it has a lesser affinity than buprenorphine) would prevent full agonist opioids, say when someone relapses, from saturating one’s opioid receptors. For the same reason, that the buprenorphine has an abnormally high affinity for one’s opioid receptors, when compared to full agonist opioids AND full antagonist overdose antidotes. It is also the same reason that taking buprenorphine (with or without naloxone) will send someone with their body still saturated with full agonist opioids into precipitated withdrawal, upon starting their buprenorphine regiment too early. The “bupe,” to simply put it, just out-competes most other opioids. Period.

    Thus, according to my logic here, it doesn’t really matter how buprenorphine, with or without naloxone, enters one’s system. Whether the ROA is sublingually as prescribed, or abused by snorting, plugging or injecting, the naloxone has no significant effect (assuming one isn’t allergic or has a negative reaction to naloxone). As such, practically speaking, Suboxone isn’t all that different from Subutex when it comes to on the ground usages.

    This notion that the combination of buprenorphine and naloxone, specifically the naloxone in the combination, prevents or discourages miss-use is more or less bunk. Maybe to some degree the addition of naloxone to buprenorphine makes people think that the naloxone will have some effect on the buprenorphine if improperly injected (as I seem to remember reading something about how the BA of naloxone in sublingual use is more or less nil, extremely low, when compared to the BA or IV use, as when the antagonist is injected without anything else to resuscitate a overdosing individual).

    I always have imagine that the reason that this idea that the naloxone will prevent miss-use was primarily either a marketing or political move by the manufacturer/patent holder, likely related to getting favorable approval from groups like the FDA and DEA. I mean, the idea is so wide spread in medicine, from the top down it would seem. That this idea is in the prescription’s packet insert and disseminated by otherwise knowledge and able doctors always bothered me. Given nothing else other than it’s inaccuracy. Obviously, regarding the topic of your OP here, Suboxone is worth a lot of money.

    I wouldn’t be at all surprised, although I don’t take the view that the pharmaceutical companies are all evil, this sure seems like a good profit motive to me: By insuring the poligical, medical and legal establishments that Suboxone is abuse proof, thanks to the addition of naloxone, or more or less so, the company making/holding the patent or right to make Suboxone stands to make a lot of money given large demand to alternative opioid addiction treatments.

    In this post I’m claiming that it doesn’t matter if one injects, smokes, plugs or snorts your full agonist opioid (lets say heroin). This is again something I have experienced, and again something I’ve heard from others in treatment, the idea that if you have a serious opioid habit going, say doing 50-100 dollars of non-bunk street dope per day, regardless of ROA, buprenorphine isn’t going to get one high. Especially if that dope has been mostly injected. Especially for people who have had a long run of consecutive (ab)using. No way, no how. In fact many of such individuals will still suffer some withdrawal symptoms, mostly related to lethargy and depression or anxiety, for the first three or four days of treatment with buprenophine. No way, no how, will such individuals get high from their initial buprenorphine doses. There is even the possibility of these folks suffering some significant component of traditional full agonist opioid withdrawal, as I’ve already referenced..

    That all said, if one waited until they’ve detoxed from their full agonist, for at least five to seven days, to start the Suboxone or Subutex, one most certainly can produce a “high,” if not as intense as a full agonist, still “warm,” “fuzzy,” itchy and “noddy.” Those folks who have only a relatively small habit and/or are relatively early in their addiction (without much of any really significant tolerance to opioids I mean), such individuals will not only be able to get high from Suboxone or Subutex, but get high in a way very, very comparable to what they’d previously experienced taking full agonist opioids. This standards regardless of ROA – snorted, pluged, smoked (yuck! although again I’ve heard from one single person who used to do this regularly with the pills and even later with the strips once Suboxone pills were pulled from the market) or injected. Makes no significant difference it what’s sucked on or injected is Suboxone or Subutex.

    So, arg this is so long. Again, my apologies for my not being succinct whatsoever here – My intention was just to state my point thoroughly and explain where I’m coming from, I hope in a respectful way. From reading some of your posts I see a number of qualities in your work that are similar or the same as some of the doctors I work with who prefer to play that exclusive Suboxone 100 game as yourself. In other words, you honestly care about your patients and remain critical regarding how their treatment might degrade some aspect to their quality of life. Such doctors generally seem to think twice about looking at this form of treatment from any one form of exclusive or narrow minded perspective (as sadly a large numbers of Suboxone doctors I have come across do). As far as I can see, you’re therefore one of the “good guys.” “Guys” being used in a gender neutral way.

    I’d love to see what if any studies there are that claim that the naloxone prevents abuse or miss-use in Suboxone patients. To be honest I haven’t done much of my own research into whether any of these exist or what they claim, but that doesn’t lead me to doubt my arguments regarding the practical inactivity of naloxone in Suboxone prescriptions (again assuming the patient isn’t allergic or reacts badly to the full antagonist. Thank the Lord (PBUH) that I never was big into using needles, but I came close at one point with a really nasty IM bth habit.

    On that note, I think it’s important to also bring up one more issue related to this. Of course, there are a small number of folks, many of which I’d imagine are part of the more “treatment-resistant” populations, who are simply addicted to using needles. “Needle fever,” I’ve heard it described, and I think most of us if not all have heard about those cases where folks suffering from PAWS inject themselves with water or saline compulsively. A lot of these people are actually technically much more addicted to the needle, regardless of their DOC. These folks, I gather from my experiences in the field, would be the ones most likely to abuse and miss-use their Suboxone (or for the matter Subutex, or pretty much any medication given to them that it’s possible to cook up and inject – like temazepam, as much as the idea of injecting “jellies” scares the crap out of me).

    Counseling related sort of behavioral and psychological work would seem to be the most important for such folks, short of them eventually just coming to believe they’ve hit their “bottom” and have one of those life-changing, startlingly dramatic experiences that can sometimes cause folks to just become totally focuses on getting off whatever drug. I can’t imagine what it would be like being in your position, as a doctor specializing in the Suboxone/addition/recovery fields, working with such folks. I mean, if you can figure out a way to minimize any complications, especially considering if a patient has demonstrated he or she will do it regardless of what you do, sanctioning any sort of buprenorphine related treatment involving the injection of the drug (with a wheel filter and proper techniques I mean, to minimize the dangers inherent to injecting drugs, especially pills or films made for sublingual or oral use).

    Alright, this is far too much for a wee little post I had intended to contribute. Your thoughts OP? Again, most interested as to what evidence you’ve encountered supporting the manufacturer’s and FDA’s claims that the naloxone in Suboxone serves to actually minimize miss-use, well in so far as it’s the presence or naloxone in the Suboxone that serves such a biological/chemical/neurological function (i,e, not because people think it does, so they don’t even try injecting).

    I have no interest whatsoever in doctors licensed to prescribed Suboxone telling their patient that it’s actually not going to make any significant pharmacological difference (other than BA and time of “come-up” I guess). That would be silly, probably resulting in more people miss-using their prescription. But I wish more doctors would be open to talking about these issues, especially when it comes to the financial burden of buying the strips compared to the generic for Subutex. These are the “bad guys” I was referring to early, those that hold some narrow minded or ideological views – such as those who vehemently inform all their patients that if they miss-use their Suboxone the naloxone will get them or cause them harm!

    If only doctors wouldn’t be so comfortable propagating this untrue idea, I wouldn’t have a bone at all to pick… I just can’t get over how unethical, whether as an outright lie or simply their uncritical internalization of such misinformation. Okay, lol, I’ll stop now. For real. Again: Your thoughts? Thanks again for reading all this and, well, giving it any of your time.

    Reply

    • Studies do show less misuse of the combination product buprenorphine/naloxone than the monoproduct buprenorphine.

      In one survey of opioid users in New Zealand, eighty-one percent of these addicts said they misused the monoproduct, containing only buprenorphine. After the combination buprenorphine/naloxone product was released, 57% of surveyed opioid addicts surveyed reported misuse of this product. Street price of the combination product was lower than the monoproduct, and subjective impressions of addicts were that the combo product was less desirable. One third reported that they had experienced opioid withdrawal after injecting the combination product. [1]

      In a more recent Finnish study, attendees of a needle exchange program were surveyed about their abuse of buprenorphine products. Seventy-five percent said they had used IV buprenorphine to treat addiction or treat withdrawal. Of the 68% who had tried the buprenorphine/naloxone combination product, 80% said they had a bad experience. The street value of the combination product was less than half of the monoproduct containing only buprenorphine, indicating a preference for buprenorphine-alone preparations. [2]

      In preparation for its approval in the U.S., a study was done by Bridge et. al., regarding the safety of the combination product as compared to the monoproduct, and they found a reduced likelihood of intravenous abuse in the combination product compared to the monoproduct.

      I’ve cited a few of the other studies as well. [3,4]

      1. Robinson et. al, “The misuse of buprenorphine and a buprenorphine-naloxone combination in Wellington, New Zealand,” Drug and Alcohol Dependence, 1993, Vol. 33(1), pp. 81-86.
      2. Alho et. al, “Abuse Liability of buprenorphine-naloxone in untreated IV drug users,” Drug and Alcohol Dependence, 2007, April 17;88(1): 75-78.
      3. Mendelson et. al., “Buprenoprhine and naloxone combinations: the effects of three dose ratios in morphine-stabilized, opiate-dependent volunteers,” Psychopharmacology, 1999, Vol 141(1), pp. 37-46.
      4. Fudala et. al, “Effects of buprenorphine and naloxone in morphine-stabilized opioid addicts,” Drug and Alcohol Dependence, 1998, Vol. 50(1), pp.1-8.

      Reply

  2. Posted by tpd on January 19, 2013 at 10:22 pm

    Very interesting, food for though. I’ll get a kick out of that logic of mine is way off, but first I’m just going to do that research. Thanks for the suggestions and little intro!

    Reply

  3. […] It was reported by the Center for Substance Abuse Research (at the University of Maryland) that Suboxone became the 28th leading drug for retail sales in 2012 for all prescription medications. Total sales are estimated to exceed $1.3 billion for 2012. I first saw this posted on Dr. Jana Burson's blog. […]

    Reply

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