In May 2016 a promising new tool in the fight against the opioid abuse epidemic received FDA approval. Since then, it has not made much of an impact. Now it will have some competition, which may fare better.
Probuphine is an implantable version of buprenorphine, a low-dose opioid used in medication-assisted treatment (MAT). Like methadone, it can help wean addicts from opioid dependence by delivering a maintenance dose of the opioid. It’s too little to get a heroin addict high, but can prevent the withdrawal pains that cause reluctant addicts to relapse.
The problem with buprenorphine is that a new opioid user can get high from it. It also needs to be administered daily. The result is that buprenorphine — Suboxone is a popular formulation — is one of the most often diverted drugs on the black market. Probuphine was developed to prevent that diversion. As an implant, it is nearly impossible to divert, and doesn’t need to be replaced for six months.
That’s even longer than Alkermes’ Vivitrol, an injectable form of naltrexone — an opioid antagonist that prevents addicts from getting high even if they do use — which is administered monthly. (Vivitrol has been marketed aggressively to drug courts and politicians as a better product because, as a non-opioid, it can’t get you high. You can overdose if you take enough of an opioid in an attempt to get high anyway.)
Probuphine seemed like an almost perfect solution. Unfortunately, it hasn’t worked out that way. Maybe the problem is that training is needed to implant Probuphine correctly. Maybe some insurers didn’t like the cost (about the same as Vivitrol on a monthly basis, but six times as much upfront). Maybe patients didn’t want an implant.
Two companies have now come up with an alternative: a once-monthly buprenorphine injection. Indivior already has received FDA approval for its Sublocade. Braeburn Pharmaceuticals (one of the pharmaceutical firms marketing Probuphine) is seeking FDA approval for its alternative, currently known only as CAM2038.
Braeburn suffered a setback when the FDA issued a complete response letter (CRL) requesting more information. It will probably only mean a delay of a few months, during which time Indivior has a clear field, and Alkermes can continue to tout Vivitrol’s superiority.
I’m not sure why CAM2038 is having a harder time than Sublocade getting approval, or if one product is markedly different than or superior to the other. The opioid epidemic is continuing, and we need all the tools we can get.
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