Author: tearj3rker
Posted: Wed Jan 04, 2012 9:37 pm
If anyone has the time / inclination, there’s a really interesting collection of studies & information about Suboxone Film here:
http://www.tga.gov.au/pdf/auspar/auspar-suboxone.pdf/
RB is referred to as the sponsor
Some of my fave bits:
| Quote: |
| Study CR92/111 involved the administration of sublingual buprenorphine solution at a dose of 4 mg then 8 mg daily to opioid-dependent subjects until Day 8. This was followed by “challenges� on Days 9, 10 and 11, in which subjects received, in random order, single doses of buprenorphine 8 mg + placebo, buprenorphine 8 mg + naloxone 4 mg and buprenorphine 8 mg + naloxone 8 mg, each given as a sublingual solution. On Day 12, subjects received a single intravenous dose of buprenorphine 8 mg + naloxone 4 mg. Withdrawal symptoms were assessed using a subject-rated 21-item questionnaire, a subject-rated visual analogue scale (VAS), and an observer-rated VAS. The investigators found no significant difference between the sublingual treatments and the intravenous challenge for any of the withdrawal measures. In summary, this study does not support the sponsor’s claim. On the contrary, it indicates that subjects who regularly take Suboxone will not experience significant withdrawal if they inject their usual dose (suggesting that the presence of naloxone in the product is not a deterrent to patients injecting their own medication). The study provides no information as to whether the naloxone content of Suboxone will produce withdrawal if injected by users who are dependent on other opioids. |
This kinda mirrors my experiences. Suboxone did induce a LOT more precipitated withdrawal in me when I IV’d it while I had a heroin habit… Subutex I could IV literally the next day and be OK. But people still seem able to inject Suboxone if that’s all they’re using, which goes against RB’s claims.
This means Suboxone still has some benefits over Subutex, because so many people who IV buprenorphine are also abusing agonists. But is it worth the risk of people being exposed to potential risk of naloxone?
| Quote: |
| The claimed benefits of the soluble film need to be weighed carefully against its clear disadvantages and against the risk/benefit profile of the currently available sublingual tablet. Naloxone is extremely unstable in the soluble film formulation, degrading rapidly to a large individual impurity or a given impurity profile at the level(s) specified. The number and high levels of impurities, whereas naloxone is relatively stable in the sublingual tablet. As naloxone is present only as an abuse deterrent, compliant patients taking the soluble film would be exposed to unnecessary additional risks with no concomitant benefit. |
| Quote: |
| The sponsor has argued that because each soluble film is packaged individually in a child- resistant laminate sachet, this should reduce the risk of unintended exposure in children compared to Suboxone tablets (although only where the patient is allowed to take a supply of the medication home for self-administration). However, if it is truly the case that the child resistance of the current sublingual tablet packaging is inferior to that of the proposed soluble film packaging, then this is an argument for improving the tablet packaging, rather than a valid rationale for registering an entirely new formulation. |
I was talking to a couple of doctors over Xmas. They said the real problem isn’t so much a skewing of data in studies. Moreso it’s that negative findings of any pharmaceutical seem to not be published in journals anywhere near as much. Most drug studies have funding from their manufacturer, which isn’t bad as studies really rely on that money. But it means companies can also influence which parts of their drug get studied. In the case of Suboxone, there seems to only be one study revealing the fact Suboxone can be injected easily, yet so many studies showing it induces more withdrawal in active heroin addicts. So when a journal sees so many studies pointing one direction, and only one pointing the other, they seem to go with the herd.
