More than a year after the Food and Drug Administration's (FDA's) rejection of a subdermal implant treatment for opioid dependence, the pharmaceutical company that partnered with the delivery system's developer has enrolled its first patients in a Phase 3 study that it hopes will generate another New Drug Application (NDA) in late 2015.
Braeburn Pharmaceuticals announced this week that the latest trial of Probuphine will enroll around 180 patients in a double-blind design that will compare the effectiveness of four of the subdermal implants to sublingual buprenorphine, with a treatment period of six months.
“This study is of particular interest to the addiction community because it focuses on people who have been stable on a relatively low dose of buprenorphine, a growing segment of the opioid-dependent population that has seldom been the focus of clinical research,” Frank Vocci, PhD, co-lead investigator of the Phase 3 study, said in a July 21 news release.
One of the FDA's concerns about the original NDA for Probuphine involved the worry that physicians would shy away from offering the treatment because of complexities associated with its surgical insertion. Braeburn stated that it has trained study investigators in the implant's insertion and removal, and the pharmaceutical company added that 15 research sites have been approved for the trial.
Braeburn and the implant's developer, Titan Pharmaceuticals, Inc., have suggested that Probuphine could prove to be a significant breakthrough during this period of increasing opioid use and addiction, because its method of delivery minimizes risk of abuse and diversion.