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FDA Approves Butrans

happyHBmomhhappyHBmom Posts: 2,070
edited 06/11/2012 - 8:45 AM in Pain Medications

Purdue Pharma L.P. Receives FDA Approval for Butrans (buprenorphine) Transdermal System CIII

STAMFORD, Conn., July 1 /PRNewswire/ -- Purdue Pharma L.P. announced today that the U.S. Food and Drug Administration (FDA) approved Butrans (buprenorphine) Transdermal System CIII for the management of moderate to severe chronic pain in patients requiring a continuous, around-the-clock opioid analgesic for an extended period of time. Butrans Transdermal System is an analgesic product that delivers continuous release of medication for seven days.



  • About time the US started using this drug for chronic pain relief, as it has been used in Europe and elsewhere for many years. It will give patients one more option in managing chronic pain, and it's Schedule 3, which is good. Thanks for posting this!
  • I'd love to hear more about this. Anyone here have experiences with this? I do not go to a PM doc because of bad experiences, so my PCP manages my meds. He is comfortable with schedule 3 drugs, but nothing more, so this could be a new option for me without having to submit to the indignity of the PMs in my area.

    So please share any info or experience you might have witht his product if you live in an area where it has been available. Thanks.
  • I've been prescribed Temgesic, the sublingual tablet formulation of buprenorphine for chronic moderate-severe pain for many years now, and I have found it to be quite helpful. The patch is used more for chronic pain nowadays, with the sublingual tablets used for breakthrough pain. The patches aren't available where I live, so I use the tablets, which are themselves quite long-lasting (6-9 hours). There are 3-day, 4-day and 7-day patches available in various countries.

    Buprenorphine is about 30 times as potent as morphine (mg for mg), and studies have shown it to be at least as effective as both morphine and oxycodone in treating a variety of painful conditions. It is classed as a partial agonist at the mu opioid receptor, although recent studies have concluded that it behaves as a pure mu agonist in the analgesic dose range. Antagonist effects are possible in very high doses (8mg and above). According to the latest research, it has a safer side effect profile compared with the other strong opioids used for chronic pain: there is a ceiling effect on respiratory depression (providing an inbuilt safety net), it causes less constipation and itching, lacks clinically significant immunosuppressive effects, causes fewer CNS effects (euphoria, dysphoria, etc.), has a milder withdrawal syndrome, and, unlike most opioids, is safe to use in patients with renal impairment.
  • Huggy, do you know or have you experienced whether tolerance develops to buprenorphine like it does with other opiates? That is one thing that has made me happy about Tramadol... I haven't had to increase my dose much at all over time. However, tramadol distrupts my sleep, so I take Norco's at night and they are becoming less effective as time passes.

    Something like this with 24 hour relief would be wonderful in a schedule 3 drug... as long as I don't become tolerant to it in a year and start needing ever increasing doses. None of the articles I have been able to find have addressed tolerance over time. The studies are normally 6-12 months in duration, though none have mentioned any need to increase doses after the initial titration even at 12 months.
  • It sounds like an amazing addition to our pain control regimen. I am quite looking forward to trying it!

    I did develop tolerance to tramadol. Or else my pain just topped the threshold above which tramadol was no longer helpful, not sure which. But it took 2 years, and there were no discontinuation effects at all.

    I am using Fentanyl patches now and would gladly replace them with something less sedating.
  • Interesting, and it looks like it is an option for opioid naive patients unlike Fentanyl patches...Thanks for sharing!
  • Dedalus, I've found that tolerance to buprenorphine is substantially less than with other opioids I've been prescribed. I began with the standard starting dose of 0.2 - 0.4mg three times a day and after a couple of months my doctor and I found that I generally needed 0.4 - 0.8mg for best results. After a year or so I found I sometimes needed to increase the dose to 1mg or 1.2mg, but I seldom need to take more than that, and my tolerance has remained the same for over ten years. Lately my pain has increased, so I may have to increase the buprenorphine or try switching to another drug for a while, but overall I've found my Temgesic intake to be surprisingly stable, considering I've been taking it for so long.

    When I was on dihydrocodeine my tolerance built far more rapidly, to the point that I decided to stop using it rather than have to constantly up the dose. My doctor switched me from dihydrocodeine to buprenorphine and it gave far more pain relief with less severe opioid side effects (including less tolerance). It doesn't always give me as much relief as I'd like - on bad days I sometimes wish for something stronger or think about increasing my dose - but on the whole it has definitely been helpful. The transdermal patches have an even lower incidence of tolerance build-up, I've heard.

    Buprenorphine is not free of typical opioid side effects, such as constipation, pruritis, and so on, but I have personally found that they are not as pronounced as with the other opioid medications I've been on over the years. It can cause some queasiness and lightheadedness when you start taking it, but this usually disappears pretty quickly (it wasn't a problem for me).

    Another thing that many patients on buprenorphine report is a kind of antidepressant effect without the unwanted side effects of antidepressants (I read somewhere that this may be due to kappa receptor antagonism, but I'm not certain about this).

    I've heard from a lot of people who've found the drug useful in treating chronic pain, and also some who've not found it to be of much help at all, so I suppose in this respect it's like any other pain medication. At the very least it provides one more option for pain patients, and the fact that it's Schedule 3 is a big plus.

  • Sounds promising! The side effects of MS Contin, constipation, etc. are really awful. I would love to be off all opioids! I guess we will see how US residents respond to it! I know some will never let go of their narcotics :''(

  • That's OK, they can have them. If I can have something that works as well with less side effects and less brain fog, let me at it!
  • FYI: According to Purdue's website, they hope to have this drug on the market by early 2011.

    Sorry if this is obvious info, but it wasn't obvious to me, so I thought I'd pass it along. If anyone hears anything different or more detailed, please post or pm me. Thanks.
  • For those who don't know, it's the same active ingredient as Suboxone.
  • BionicWoman said:
    For those who don't know, it's the same active ingredient as Suboxone.
    Interesting. I wonder why it has only been approved for addiction treatment in the US until this point? And is that going to create a built-in stigma that will make doctors and patients avoid it when it is on the market for chronic pain?
  • Buprenorphine has been available for pain relief in the US for some time, but only in injectable form (Buprenex). For some reason, the sublingual and transdermal formulations for pain relief have remained unavailable, despite their growing popularity in chronic pain treatment in many other countries. Buprenorphine has really been known mostly for its secondary use as a substitute drug in opioid addiction/dependence treatment in the US (as Subutex and Suboxone), where this has been its main role for almost a decade. The main brands used outside the US for treating pain are Temgesic (sublingual) and BuTrans, Transtec and Norspan (transdermal patch). Doses used in analgesia are generally far lower than those used in addiction treatment.

    I hope there will be no stigma attached to the drug, because it's only relatively recently that it has been used for treating addiction - for the last 20-30 years its primary use has, in most countries, been in the treatment of moderate to severe pain. Like oxycodone and oxymorphone it's a semi-synthetic thebaine derivative, but its favorable safety profile and less addictive nature have kept it at Schedule 3 (it actually used to be Schedule 5) instead of Schedule 2. Unlike some of the other strong opioids, it has no significant immunosuppresive action, nor does it affect hormone levels. Of course, as an opioid drug it still has some potential for abuse.

  • The first 3 paragraphs of the approval letter are certainly enlightening -
    Please refer to your New Drug Application (NDA) dated November 3, 2000, received November 3, 2000, submitted under section 505( b ) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Butrans (buprenorphine) Transdermal System for transdermal administration (5 mcg/hour, 10 mcg/hour, and 20 mcg/hour).


    We acknowledge receipt of your amendments dated November 28, and December 15 (2) and 18 (2), 2000, January 9 and 10, February 28, March 9, 13, 21, 26, and 30, April 18, 26, and 27 (2), May 3, 4 (2), 14, 24, and 25, June 4, 6, 7, 8, 11, 15, 20, 21, 23, 26, 27, 28, and 29, July 11, 16, 19, 23 (2), 25, 26, and 30, and August 15 (2), 2001, September 25, October 8, 15, and 27, November 3, 5, 9, 10, 11, 13, 20, and 30, and December 9, 17, 28, and 30, 2009, January 7, 15, 27, and 28, February 3 and 18, March 1 (3), 5, 10, and 30, April 21 and 23, and June 16 (2), 22, 23, and 29, 2010.

    The September 25, 2009, submission constituted a Complete Response to our August 31, 2001, Action Letter.
    If my count is correct, it took 9 years and 87 letters to create a complete answer to 1 letter from the FDA. 8}
  • So let me get this straight. They use it for pain relief in injectable form. It's available sublingual for other uses, but doctors don't use it off-label?

    LOL, they use everything else off label, the FDA musta warned them good.
  • I don't get why they didn't just make it available in sublingual and transdermal form for pain relief, the way it has been used in other countries for 20+ years before it was used as an addiction treatment drug. Maybe that has something to do with it - the US started using it for that purpose in 2002, if I'm not mistaken, so maybe they wanted to confine it to that specific use. It all sounds awfully complicated...

    I hope it helps those chronic pain patients who need something that is pretty strong and also relatively safe to take on a long term basis. The Schedule 3 thing should help, at least.
  • I suspect it is because the doses used for pain relief are not available. Or because the controls needed aren't there. Who knows?
  • I wondered the same thing after reading about this medication. If it can be used in Suboxone, why can't it be used for pain management? This country is so woefully behind in medicine!
  • Actually it is used to treat moderate to severe chronic pain that continues around-the-clock and is expected to last for a long period of time. I would not prefer because it contains huge side effects.
  • What 'huge' side effects are those?

    In fact, the side effect profile of buprenorphine is generally favourable when compared to other opioids. The usual adverse effect culprits of opioid use like constipation and pruritis are rather less common with buprenorphine, as is respiratory depression. Unlike many other opioids, it has no significant adverse effects on immunosuppressive function, nor does it affect hormonal levels (a concern with other strong opioids when used long-term). As someone who has been prescribed this medication for a long time, I have found its side effects milder than other opioids. It can cause some drowsiness and nausea at first, like any other opioid medication, but this generally subsides after a few days.

    My guess is that, as with any other opioid analgesic, some will find it helpful and some will not, but to write it off completely because of possible side effects is a bit over the top, in my opinion - the same could be said after looking through the list of possible adverse effects of any of the commonly used pain medications, even more so with the anticonvulsant and antidepressant drugs (which to me have always had far more unpleasant side effects than the opioids).
  • Yes, it's a long-acting pain med for moderate to severe chronic pain. Many of us fall into that category and take meds around the clock. Not sure why that's a shock.

  • I have been on these for about 1 yr, I started on 5mcg patch which you change every week, I had no side effects but the pain was not controlled, I was upped to 10mcg patch and I am now on 10mcg and 5mcg patches together, the only down side I have is that I can only wear them on my arms as the itching is too intense on other areas of my body,they are thinking of upping them again but my pain management doc is away on holiday, so I have been given oxycodone liquid to try until he comes back, sadly none of the chemists keep it in stock so I am in a lot of pain waiting for it to arrive, hopefully it will be today.
    If you are able to get these patches I would try them, tablets never lasted long enough for me, and my GP would not give me any more breakthrough meds
  • Glad the patches are working for you! I can only get the sublingual tablets over here - they are supposed to last about 6-8 hours (I find they are generally effective for around 5-6 hours, but everyone's different). The key with this medicine, as with so many others, seems to be finding the right personal dose and then a combination of other drugs that work well with it (muscle relaxants, NSAIDs if necessary, antidepressants/anticonvulsants for neuropathic pain, etc.).
  • My Dr. asked if I wanted to try Butrans patches. They last for a week and said they start at 5mcg and the next week at 10 and so on until I get pain relief. But she gave me a script for my regular Oxycontin 2-40mg a day and may use 3 if needed and to let her know if I need 3 a day consistently she will put me on the patches. I wouldn't mind but concerned about the low starting dose at 5mcg not covering my pain. Did anyone have another med to fall back on? I hate to go to the ER not getting enough pain relief. Charry
    DDD of lumbar spine with sciatica to left hip,leg and foot. L4-L5 posterior disc bulge with prominent facets, L5-S1 prominent facets with a posterior osteocartilaginous bar. Mild bilateral foraminal narrowing c-spine c4-c7 RN
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