There have been a number of events over the past couple weeks that have been ‘game changers’ in the efforts by Reckitt Benckiser to hang onto their profitable treatment for opioid dependence, Suboxone. Reckitt Benckiser (RB) had asked the FDA to deny any future generic drugs based on Suboxone tabs because of deaths of several chldren, who might have confused the tabs for candy.
The FDA gave RB’s comments some thought and then discarded them, even stating that the efforts by RB might have been unlawful anticompetetive marketing. The FDA wrote that they were referring their concerns about unlawful marketing to the FTC.
The FDA went on to approve two generic versions of Suboxone, or more properly, buprenorphine/naloxone tablets. It will be interesting to see whether insurers and medicaid agencies go back to covering tabs (generic tabs), or whether they will continue to waste money on the heavily-marketed Suboxone’film.’
Just in case that isn’t enough drama for one week, the FDA announced that they will be holding hearings to determine whether to approve a buprenorphine implant called Probuphine.. I’d love to share details about the product, but at this point I don’t have further information. The manufacturers of Probuphine are hoping that the medication will be used to treat opioid dependence. On the surface, a number of advantages are apparent about such a product; one would expect a lower risk of diversion, for example, and better compliance.
NOT mentioned at this point, is whether the implant could help people who would like to discontinue Suboxone. Many patients on Suboxone become resentful of the medication at some point, wishing they could be completely free from opioids. I’m not a big proponent of such an idea, as I’ve witnessed far too much death and misery from relapse by people who stopped Suboxone. But I could see how an implant would offer advantages for those people, depending on the release pattern of the medication. For example, if the medication wears off slowly in the lower dose range, it may serve as a useful tapering device. Such use would likely be off-label, and might even be illegal, depending on the wording of the product label.
The FDA hearings are open to the public. Check back in a couple days and I’ll provide information about the hearings, including details about how you could become a participant.
Colored pills photo available from Shutterstock
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Last reviewed: 4 Mar 2013