What You Need to Know About Probuphine
After extended negotiations with the Food and Drug Administration (FDA), Titan Pharmaceuticals can finally conduct a full clinical study of Probuphine, an investigational implant device using buprenorphine to treat opiate addiction. The study, which was submitted for FDA review back in March, is expected to enroll its first participants in a matter of weeks. The study itself will not see completion until the middle of 2015.
What is Probuphine?
Buprenorphine, the same drug found in Suboxone and Subutex, prevents physical withdrawal from opiates, limits cravings, and blocks the effects of drugs like heroin, OxyContin, or hydrocodone. What makes Probuphine different is that it comes in the form of an implant. The medication is contained within four small, solid rods.
After initially stabilizing on sublingual Suboxone, a physician places the implant under the skin in a fan formation, usually in the upper arm. This simple in-office procedure – from start to finish – can be performed in less than 30 minutes.
Probuphine Clinical Study Preview
Per the FDA guidelines, Probuphine’s clinical study is expected to enroll approximately 180 patients. Each of the participants must be clinically stable and receiving maintenance treatment via a pre-approved sublingual formulation of buprenorphine. Additionally, the group must be on a daily dose of buprenorphine that equals 8mg or less.
Study participants will either receive a Probuphine implant or continue taking daily doses of sublingual buprenorphine.
Study participants will either receive a Probuphine implant or continue taking daily doses of sublingual buprenorphine. To ensure the highest level of accuracy and integrity in this study, patients receiving Probuphine implants will be given daily placebo sublingual pills, while those continuing with a stable dose of sublingual buprenorphine pills will also receive placebo implants.
The patients will be treated and evaluated for six months. Researchers must provide the FDA with timely and frequent progress updates. Official conclusions will be based on the feedback and physical data obtained from participants.
Potential Benefits of an Implant
Probuphine seems to overcome the standard objections related to Suboxone or Subutex use. With a growing number of buprenorphine films and tablets being sold on the black market, Probuphine could offer a much needed solution. The implant cannot be diverted, stolen, lost, abruptly stopped by the patient, and cannot be accidentally overdosed. Additionally, when buprenorphine is delivered via implant, accidental (and frequently fatal) pediatric exposures would likely become a thing of the past.
The implant cannot be diverted, stolen, lost, abruptly stopped by the patient, and cannot be accidentally overdosed.
The FDA Advisory Committee has its concerns with Probuphine. For instance, doctors implanting the device will need to receive proper training to perform the procedure. So far, it’s unclear who will pay for this training and what the guidelines are for proper implantation. Additionally, members of the committee have voiced concern about Probuphine providing a steady – and adequate – dose of buprenorphine for a duration of six months. With any luck, data obtained from the Titan Pharmaceutical study will provide answers that satisfy and reassure all parties involved.
Also Read: The Buprenorphine Diversion Problem