First Buprenorphine Implant for Opioid Dependence Gets green Signal from US FDA

The U.S. Food and Drug Administration on 27th May accepted Probuphine, the first buprenorphine implant for the maintenance therapy of opioid dependence. Probuphine is developed to offer a constant, low-level dose of buprenorphine for 6 months in sufferers who are already constant on low-to-moderate doses of other types of buprenorphine, as part of a complete therapy program.

Till today, buprenorphine for the therapy of opioid dependence was only accepted as a pill or a film positioned under the tongue or on the inside of a person’s cheek till it dissolved. While efficient, a pill or film may be lost, forgotten or stolen. On the other hand, as an implant, Probuphine offers a new therapy choice for individuals in recovery who may value the unique advantages of a 6 month implant in comparison to other types of buprenorphine, such as the possibility of enhanced patient convenience from not requiring to take drugs on a day-to-day basis. An independent FDA advisory committee backed the acceptance of Probuphine in a meeting held previously this year.

FDA Commissioner Robert M. Califf, said

“Opioid misuse and addiction have taken a toll on American families. We need to do anything we can make to new, modern therapy options accessible that can assist patients regain control over their lives. This acceptance offers the first-ever implantable choice to support patients’ initiatives to manage treatment as part of their overall recovery program.”

Broadening the use and accessibility of medication-assisted treatment (MAT) choices like buprenorphine is an essential component of the FDA’s opioid action plan and one of three top priorities for the U.S. Department of Health and Human Services’ Opioid Initiative targeted at decreasing prescription opioid and heroin associated overdose, death and dependence.

MAT is an extensive method that fuses approved drugs (currently, methadone, buprenorphine or naltrexone) with counseling and other behavioral treatments to treat sufferers with opioid use disorder. Regular adherence to MAT with buprenorphine decreases opioid withdrawal symptoms and the desire to use, without resulting in the cycle of highs and lows related with opioid misuse or abuse. At adequate doses, it also reduces the pleasurable results of other opioids, making continued opioid abuse less appealing. According to the Substance Abuse and Mental Health Services Administration, sufferers getting MAT for their opioid use disorder reduce their possibility of death from all causes in 50 percent.