USFDA approves first buprenorphine implant for treatment of opioid dependence

MUMBAI: US Food and Drug Administration has approved Probuphine, the first buprenorphine implant for the maintenance treatment of opioid dependence. Probuphine is designed to provide a constant, low-level dose of buprenorphine for six months in patients who are already stable on low-to-moderate doses of other forms of buprenorphine, as part of a complete treatment programme.
Till now, buprenorphine --for the treatment of opioid dependence-- was only approved as a pill or a film placed under the tongue, or on the inside of a person’s cheek until it dissolved.While effective, a pill or film may be lost, forgotten or stolen. However, as an implant, Probuphine provides a new treatment option for people in recovery who may value the unique benefits of a six-month implant compared to other forms of buprenorphine, such as the possibility of improved patient convenience from not needing to take medication on a daily basis.
An independent FDA advisory committee supported the approval of Probuphine in a meeting held earlier this year. "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,” said FDA Commissioner Robert M Califf, “Today’s approval provides the first-ever implantable option to support patients’ efforts to maintain treatment as part of their overall recovery programme.”