The Psychopharmacologic Drugs Advisory Committee (PDAC) of the Food and Drug Administration (FDA) voted 12 to 6 for the approval of Probuphine implant for treating opioid addiction. Probuphine is the first long-acting subdermal buprenorphine implant that delivers 8 mg or less per day of the drug to the patient.
At the recent meeting, doctors presented efficacy data from a recent clinical study confirming Probuphine’s effectiveness as a 6-month maintenance treatment for opioid dependence. Several sensitivity analyses were presented at the meeting, and the FDA evaluated the results that favored Probuphine. In addition, safety findings showed how insertion and removal procedures were safe.
What are Opioids?
Opioids are a class of drugs that include licit prescription pain relievers, as well as the illicit drug heroin. Commonly abused opioids include oxycodone, fentanyl, codeine, hydrocodone, and morphine. Opioids interact with opioid receptors that lie on the nerve cells of the brain tissue. These receptors produce pleasurable effects when activated, relieving pain.
Addiction is a chronic, primary, and relapsing brain disease characterized by a person pursuing reward and relief by using substances. Around 21.5 million Americans have a substance use disorder, and of these individuals, almost 2 million use prescription pain relievers. In addition, 586,000 people use heroin, with 23% of these individuals developing an opioid addiction.
Drug overdose is now the leading cause of accidental death in the United States. According to recent data, there are around 19,000 overdose deaths related to prescription pain medicines each year, and approximately 10,500 overdose deaths are related to heroin annually.
How does Probuphine Work?
Probuphine offers the best chance of individuals with opioid addiction to reach recovery goals. This new treatment is a real option for millions of patients and their families who suffer from opioid addiction. Probuphine provides maintenance treatment continuously for 6 months, decreases the risk of diversion, eliminates the need to visit the clinic frequently, and improves people’s quality of life.
Probuphine is merely a small rod that contains buprenorphine, which is a medication approved by the FDA for opioid addiction. The rod is positioned under the skin of the upper arm in a simple office procedure. The implant delivers a daily dose of medication to the patient without the need for taking pills or injections.
The buprenorphine implant has several benefits. These include:
- You do not have to worry about taking a pill every day.
- You will not experience the side effects of Suboxone, such as the awful taste.
- You won’t have to worry about the medication being stolen, lost, or sold.
- If you have to go to jail or attend rehab, the implant will continue working, so there is no chance of withdrawal or interruption in treatment.
- The treatment is more effective than short-term detoxification followed by maintenance medicines.
What is involved in the Treatment Program?
The Probuphine 6-month implant is used as a part of a complete treatment program that includes psychological support and counseling. Probuphine consists of 4 one-inch-long rods that are implanted beneath the skin of the upper arm. The doctor administering the medication is specially trained for the surgical insertion and removal procedure. The doctor must become certified through the Probuphine Risk Evaluation and Mitigation Strategy (REMS) program.
Is the Probuphine Implant Safe?
In a recent randomized clinical trial, the safety and efficacy of Probuphine were demonstrated. The participants were adults who met strict clinical criteria for opioid dependence. This was measured using self-reporting illicit opioid use and urine screening. Of the participants, 64% had no evidence of opioid use throughout the six months of evaluation and implant treatment.
American Society of Addiction Medicine (2016). Opioid Addiction.
Food and Drug Administration (2016). FDA approves first buprenorphine implant for treatment of opioid dependence.