- The FDA on Thursday approved Probuphine, the first buprenorphine implant for maintenance treatment of opioid dependence, but will require it to carry a black box warning.
- The device provides a constant, low dose of buprenorphine for six months to support patients who are already taking other forms of the drugs. Until now, treatment with buprenorphine has been based on taking pills or dissolvable film.
- The launch of marketing of Probuphine should be bolstered by funding that Congress approved in February, which will provide $103 million each year from 2017 to 2021. It is intended to provide states with financial support for preventing and treating opioid addiction.
Probuphine provides a method for helping patients adhere to opioid treatment maintenance programs. There are a couple of important caveats that come with the approval. First, patients must already be in a maintenance program, and they can only be taking eight milligrams or less of buprenorphone. Physicians must also take a four-hour training class before they can prescribe it.
The agreed-upon dosing is related to previous FDA rejection of the Probuphine implant, according to Bloomberg. The FDA rejected it in 2013 because they said that the dosing would be too low to provide effective treatment. Titan and Braeburn changed their approach to only offer it as part of a maintenance program for patients on lower doses of buprenorphine.
In a clinical trial of adults, 63% of Probuphine-treated patients had no evidence of illicit opioid use through six months.
In a statement, FDA Commissioner Dr. Robert M. Califf, said: "Opioid abuse and addiction have taken a devastating toll on American families. We must do everything we can to make new, innovative treatment options available that can help patients regain control over their lives."
The FDA has taken a more aggressive approach to dealing with the growing number of opioid overdoses in the U.S., which have devastated communities in many states. Lawmakers had sharply criticized the agency for its previous approach.
Titan and Braebrun will be required to conduct post-marketing studies to further evaluate the safety and efficacy of the Probuphine implants for additional courses of treatment beyond initial dosing.