US regulators have approved the first buprenorphine implant to help treat people addicted to opioids, including prescription painkillers and heroin.
Probuphine is a subdermal implant, made by Titan Pharmaceuticals and Braeburn Pharmaceuticals, which continuously delivers a low-level dose of buprenorphine for up to six months.
It can be used in clinically stable patients who are on low-to-moderate doses of other forms of buprenorphine, alongside a complete treatment programme that should include counselling and psychosocial support.
Until 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. Although effective, these forms of the drug may be lost, forgotten or stolen. As an implant, Probuphine side-steps these issues and offers improved convenience from not having to take medication on a daily basis.
The safety and efficacy of the implant were shown in a randomised clinical trial of adults who met the clinical criteria for opioid dependence and were considered stable after prior buprenorphine treatment. Sixty-three percent of Probuphine-treated patients had no evidence of illicit opioid use throughout the six months of treatment - similar to the 64 percent of those who responded to sublingual buprenorphine alone.
On the safety side, the systemic side effects for Probuphine are similar to those that are seen with other forms of buprenorphine and include: headache, insomnia, upper respiratory tract infection, nausea, anxiety, back pain, depression, constipation, and vomiting. In addition, common implant site reactions included pain, itching, redness and swelling.
The product also carries a boxed warning providing safety information for health care professionals, including a warning that insertion and removal of Probuphine are associated with the risk of implant migration, protrusion, expulsion and nerve damage resulting from the procedure.
"Opioid addiction is a chronic disease and should be treated the same way we treat other serious, chronic diseases -with evidence-based medicine," said president and chief executive of Braeburn, Behshad Sheldon. "With 78 people in the US dying each day from opioids, it's important that patients have more treatments to choose from as no one option will work for everyone".
The product is expected to launch in the US on June 21.