Only one company made buprenorphine implants. In 2020, that company stopped making the product due to financial constraints, including low payments from insurance companies. In press releases, Titan Pharmaceuticals said sales of the product Probuphine may continue in a very limited way.[1] But as of now it is not available to patients in the United States.
What Was Probuphine?
Pharmaceutical researchers work tirelessly to find new addiction treatment approaches. For several years, Probuphine was considered a promising, innovative treatment for opioid use disorder.
How Did Probuphine Work?
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 had 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]
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.
Doctors implanted a small device through a quickly healing incision. Every six months, their patients come back for another implant.
Probuphine Medical Trial Results
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% showed no evidence of relapse during the six-month study period. About 13% of the participants needed supplemental sublingual buprenorphine during the study but showed no evidence of relapse.
Probuphine Is Discontinued
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.[6] The COVID-19 pandemic reportedly exacerbated financial issues with manufacturing and distributing the implant.
However, in their press release, Titan noted that they had entered an agreement with J.T. Pharma to use ProNeura’s implant technology for further opioid treatment medications. Perhaps ProNeura will be available again in the U.S. in the coming years.
Alternative to Probuphine: Sublocade
Sublocade is a subdermal injection that forms a gel patch beneath the skin.[7] 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 past the acute stages of opioid withdrawal who have remained stable on daily oral Suboxone.
If you are interested in Sublocade for treating OUD, speak with your provider to determine if it might work for you.
By Elena Hill, MD, MPH
Elena Hill, MD; MPH received her MD and Masters of Public Health degrees at Tufts Medical School and completed her family medicine residency at Boston Medical Center. She is currently an attending physician at Bronxcare Health Systems in the Bronx, NY where ... Read More
- Titan to Discontinue U.S. Sales of Opioid Addiction Implant in Restructuring. S&P Global Market Intelligence. https://www.spglobal.com/marketintelligence/en/news-insights/latest-news-headlines/titan-to-discontinue-us-sales-of-opioid-addiction-implant-in-restructuring-60747432. October 2020. Accessed January 2023.
- FDA Approves First Buprenorphine Implant for Treatment of Opioid Dependence. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-approves-first-buprenorphine-implant-treatment-opioid-dependence. June 2016. Accessed January 2023.
- Medication-Assisted Treatment for Opioid Use Disorder Study (MAT Study). Centers for Disease Control and Prevention. https://www.cdc.gov/opioids/Medication-Assisted-Treatment-Opioid-Use-Disorder-Study.html. June 2019. Accessed January 2023.
- Synthetic Opioid Overdose Data. Centers for Disease Control and Prevention. https://www.cdc.gov/drugoverdose/deaths/synthetic/index.html. March 2021. Accessed January 2023.
- Probuphine (Buprenorphine) Subdermal Implants for the Treatment of Opioid-Dependent Patients. Pharmacy & Therapeutics. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5521298/. August 2017. Accessed January 2023.
- Titan Pharmaceuticals Provides a Strategic & Corporate Update. PR Newswire. https://www.prnewswire.com/news-releases/titan-pharmaceuticals-provides-a-strategic--corporate-update-301153017.html. October 2020. Accessed January 2023.
- How Sublocade Works. Sublocade.com. https://www.sublocade.com/how-sublocade-works. Accessed January 2023.
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