Probuphine is a buprenorphine-releasing subdermal implant sold under the name ProNeura. It was approved by the FDAin 2016 but was discontinued by Titan Pharmaceuticals in 2020 — not due to safety issues but due to costs, which were exacerbated by the pandemic.
While Titan is using the ProNeura technology to develop other opioid treatment methods, other pharmaceutical companies offer alternatives like Sublocade monthly injections. This injection also releases buprenorphine into the bloodstream without requiring the individual to take a tablet or sublingual film every day.
Probuphine: Buprenorphine Implant No Longer Available in the US
Pharmaceutical researchers work tirelessly to find new approaches to medication for addiction treatment (MAT).
For several years, Probuphine was a promising, innovative approach to treating opioid use disorder (OUD), but in October 2020, this buprenorphine-releasing implant was discontinued by its manufacturer Titan Pharmaceuticals.
According to a press release from Titan, the discontinuation was not due to the product’s ineffectiveness or safety concerns, but because maintaining production of the implant while meeting the high standards of safety and effectiveness for MAT medications in the U.S. proved too costly.[1] The COVID-19 pandemic reportedly exacerbated some of the financial issues with manufacturing and distributing the implant.
However, Titan noted in their press release that they had entered an agreement with JT Pharma to use ProNeura’s implant technology for further opioid treatment medications. Perhaps ProNeura will be available again in the US in the coming years.
What Is Probuphine?
The United States Food and Drug Administration (FDA) approved Probuphine in 2016, aiming to improve access to treatment for opioid use disorder among Americans.[2]
That year, the Centers for Disease Control and Prevention (CDC) reported that 2.1 million people in the country suffered from an opioid use disorder (OUD).[3] Thousands of people have died every year from opioid overdoses, particularly as fentanyl has become the dominant illicit opioid, and thousands more suffer serious health complications after an overdose.[4]
Treating OUD is vital. Finding new treatments is incredibly important.
The Probuphine implant was designed to provide a slow, consistent, low-level dose of buprenorphine over six months. The dose was appropriate for people who had stabilized on other forms of buprenorphine, like Suboxone, earlier in their treatment program.
Ideal candidates for Probuphine are individuals who had moved past the acute phase of withdrawal and had been stable on Suboxone therapy for a period of time.
How Probuphine Worked
Probuphine was supplied under the brand name ProNeura in four implants containing 74.2 milligrams of buprenorphine. The implants are inserted through a small subdermal incision that then quickly heals.
After Probuphine is implanted, it takes about 12 hours for maximum plasma concentration to be achieved, with steady state buprenorphine levels achieved by the end of the first month.
Until Probuphine, daily sublingual film strips were the only maintenance medication available to Americans overcoming OUD. Having an implant form of buprenorphine once again available in the US could help people remain stable and focused on treatment without having to take daily buprenorphine doses by mouth.
Results of Medical Trial for Buprenorphine Implant
The medical research trial showed excellent results for the implant.[5] The study group consisted of 177 adults who had opioid dependency as their primary diagnosis, who took no more than 8 mg of Suboxone per day to maintain abstinence, and who were clinically stable.
Of the group, 63 percent showed no evidence of relapse during the six-month study period, similar 64 percent of those taking daily oral Suboxone. About 13 percent of the participants needed supplemental sublingual buprenorphine during the study period but showed no evidence of relapse.
Probuphine reported additional benefits, including these:
- Improved treatment compliance
- Reduced risk of medication diversion
- Less frequent administration
- Nonfluctuating, consistent levels of medication in the blood
Side effects associated with Probuphine are similar to those associated with other types of buprenorphine medication. They include the following:
- Headache
- Nausea and vomiting
- Constipation
Some side effects were unique to the implant, like these:
- Implant migration
- Protrusion
- Expulsion
Alternatives to Probuphine: Sublocade
Although Probuphine is not currently available in the US, the implant shows that extended-release or continued-release medications worked well for people overcoming OUD. A new injectable medication, Sublocade, works similarly to the implant, but it does not require an invasive procedure.
Sublocade is a subdermal injection, which forms a gel patch just beneath the skin.[6] This injection is administered once a month and releases a consistent amount of buprenorphine into the body slowly over time. Sublocade, like Probuphine, is most appropriate for people who are past the acute stages of opioid withdrawal and who have remained stable on daily oral Suboxone for a period of time.
If you are interested in Sublocade for treatment of OUD, speak with your provider. You doctor can help you determine if Sublocade might wok for you.
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