If you need a refresher on this drug, it’s used to treat opioid addiction (addiction to painkillers like OxyContin andVicodin, for example). When used in Subutex and Suboxone, it “enable[s] opioid-addicted individuals to discontinue the misuse of opioids without experiencing withdrawal symptoms,” according to SAMHSA. It carries a lower risk of abuse than heroin and methadone, which is designed to perform the same function, although the potential is there, experts say.
And that was one of the concerns the FDA voiced when the drug came up for review this month. All you had to do wass follow the press to learn the progress of the FDA’s actions. On 3/19, preliminary to an FDA Drug Advisory meeting, the organization released a document containing its thoughts. Shortly afterward, a MedPage article headline proclaimed: “FDA Staff Not Thrilled About Opioid Implant.”
It seems that during clinical trials, some people still needed oral Suboxone to ward off withdrawal symptoms, which in turn, meant that the company’s claims that implants would reduce pediatric exposure to the medication were not reliable. (The company said that with five rods, patients would receive a steady dose of medication for up to 4 to 6 months.)
Or, as Treatment Magazine’s editor succinctly put it, after reading the document:
“Long-acting buprenorphine implants, already brand named Probuphine by Titan Pharmaceuticals as the tiny specialty pharma moves through trials and FDA approvals for the implantable opioid replacement therapy, got a decidedly negative review by FDA staffers in what is the key aspect of the implants - their ability to completely replace daily dosing and thus solve a range of thorny bup issues ranging from diversion to proper dosing and even the possibility of cutting back on the highway robbery $150 to $300 monthly doctor's visits.”
However, two days later, a Medscape article stated “FDA Panel Says a Cautious ‘Yes’ to Buprenorphine Implant.” The writer summarized the panel’s findings as follows:
“The vote was 10 to 4 (with 1 abstaining) that the efficacy, safety, and risk-benefit data supplied by the company supports approval.
The panel ‘seemed to agree that this is a product with great potential utility, but there is some deficiencies in terms of dosing and REMS (Risk Evaluation and Mitigation Strategies) but that overall need for a product such as this on the market exceeded those deficiencies,’ said panel chair Edward Covington, MD, from the Cleveland Clinic Foundation.”
(You might need to register on Medscape to read the article.)
I know implants have been used for birth control for quite some time; it’s interesting to consider them for addiction treatment. You’d think that the convenience would be a big selling point for addicts, but the potential for abuse never occurred to me. And the safety question is troublesome, too. The FDA may have its critics, but it’s a good thing we have them to monitor new therapies
Joan added: Detoxing clients from suboxone or subutex presribed for "long term" pain management is for the most part a long and agonizing ordeal. The last 2 mg are especially difficult. I wrote about Krissie Bergo's detox from the suboxone here. I wonder if the FDA took the end game into consideration. Just what is it like to detox from a buprenorphine implant? Or is the FDA expecting people to have the implant for life?