After the Food and Drug Administration (FDA) decided last year not to approve implantable buprenorphine to treat opioid abuse, researchers have begun a new study to address the agency’s concerns about the product, called Probuphine.
The study will compare Probuphine to buprenorphine/naloxone which is taken under the tongue. Approximately 190 patients are being enrolled in the study at about 20 sites around the country. They will be randomly assigned to receive either an implant of Probuphine in the upper arm, along with placebo tablets under the tongue; or a placebo arm implant, along with buprenorphine/naloxone tablets. Probuphine implants are designed to be effective for at least six months.
The study participants are people treated for opioid dependence who have been stable while taking buprenorphine/naloxone for several months, without using any illicit opioids, says Frank Vocci, Ph.D., co-principal investigator.