Last week, The Fix reported that a subdermal buprenorphine implant called Probuphine was awaiting FDA approval.
On January 12, an advisory committee of the U.S. Food and Drug Administration (FDA), approved the implant in a 12 to 5 vote in favor.
Here is a quick recap of what Probuphine is. It’s a subdermal implant, meaning it is surgically placed under the skin, typically in the patient’s upper arm. About the size of a matchstick, the device will release a steady dose of 8mg or less per day of buprenorphine for six months, to treat stable but opioid dependent patients.
Buprenorphine, commonly referred to by its brand name Suboxone, or Subutex, is a partial agonist at opioid receptor sites. Drugs such as heroin and OxyContin are full agonists, thus causing the intense high followed by even more intense craving. Buprenorphine currently comes in tablet or film formulations, which a patient must take daily by self-administration.
Probuphine, on the other hand, bypasses self-administration by maintaining a steady dose of buprenorphine over a six-month period. The implant “could increase patient compliance, decrease the risk of diversion and improve patients’ quality of life,” said Titan Pharmaceuticals President and CEO Sunil Bhonsle in a press release.
The efficacy and safety of Probuphine has so far been studied in several clinical trials, including a 163-patient, placebo-controlled study over a 24-week period, as well as in a follow-up study of 287 patients, published in the journal Addiction.
“The ability to now deliver the medication in a safer way for individuals, their families and society is truly a breakthrough,” said mental health activist Rep. Patrick J. Kennedy.
Amidst the opiate scourge occurring across America, sales of buprenorphine products to treat opioid dependence in 2014 were approximately $1.75 billion in the United States. Probuphine is the most recent newcomer to the market. There was no mention of the devices cost in the press release.