The first buprenorphine implant that helps treat people who have opioid dependency has been approved by the US Food and Drug Administration (FDA)
The Probuphine implant 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.
An independent FDA advisory committee supported the approval of Probuphine in a meeting held earlier this year.
FDA commissioner, Robert Califf, said: “Today’s approval provides the first-ever implantable option to support patients’ efforts to maintain treatment as part of their overall recovery programme.”
According to the FDA, Probuphine should be used as part of a complete treatment programme that includes counselling and psychosocial support,
The Probuphine implant consists of four, one-inch-long rods that are implanted under the skin on the inside of the upper arm and provides treatment for six months.
Administering Probuphine requires specific training because it must be surgically inserted and removed. If further treatment is needed, new implants may be inserted in the opposite arm for one additional course of treatment.
The FDA is requiring postmarketing studies to establish the safety and feasibility of placing the Probuphine implants for additional courses of treatment.
The safety and efficacy of Probuphine were demonstrated in a randomised clinical trial of adults who met the clinical criteria for opioid dependence and were considered stable after prior buprenorphine treatment.
63% of Probuphine-treated patients had no evidence of illicit opioid use throughout the six months of treatment – similar to the 64% of those who responded to alternative sublingual (under the tongue) buprenorphine.
Opioid dependence is the diagnostic term used for the more common concept, “addiction,” in the Probuphine clinical trials.
Probuphine is marketed by San Francisco-based Titan Pharmaceuticals and Braeburn Pharmaceuticals based in Princeton, New Jersey.