Fighting addiction from within.
Last week (May 26), the US Food and Drug Administration (FDA) announced its approval of the first implant to help treat opioid dependence, dubbed Probuphine.
The implant is designed to provide a constant dose of buprenorphine — a drug used to treat opioid addiction — for six months.
One of the more well-known brands of a buprenorphine medication is Suboxone, and it’s usually taken as a pill or a film that dissolves under the tongue. However, the medication is only effective when taken correctly, and the FDA stresses that pills or films can be lost, forgotten, or stolen. Notably, buprenorphine itself can be addictive, so addicts also run the risk of manifesting their addiction in another substance if they don’t stick to the prescribed dosages.
Probuphine, which was developed by Titan Pharmaceuticals, solves this problem by delivering low-doses of buprenorphine round-the-clock, not to mention it’s easier not having to worry about taking medications every day.
"Opioid abuse and addiction have taken a devastating toll on American families. We must do everything we can to make new, innovative treatment options available that can help patients regain control over their lives,” FDA Commissioner Robert M. Califf said in a press statement. “Today’s approval provides the first-ever implantable option to support patients’ efforts to maintain treatment as part of their overall recovery program.”
The implant consists of four one-inch rods that are inserted under the skin of a patient’s upper arm by a trained medical professional.
Courtesy of Braeburn Pharmaceuticals. Image has been cropped.
In a randomized clinical trial, researchers demonstrated the safety and efficiency of Probuphine. A response to the medically-assisted therapy (MAT) was measured by self-reported illicit opioid use as well as urine screenings during the six-month treatment period.
At the end of the trial, 63 percent of the Probuphine-treated patients had no evidence of illicit opioid use — similar to the 64 percent of patients who had responded to the tongue-dissolving buprenorphine. The study didn’t include patients under the age of 16 or over the age of 65, so more research will be needed to establish the safety for younger or older patients.
Unfortunately, the implant isn’t free of side effects. Based on their research, the scientists found the most common side effects were implant-site pain, itching, as well as side effects that are common to all buprenorphine products: headaches, depression, constipation, nausea, vomiting, back pain, and toothaches. There are also possible complications from the surgical implantation of the device including implant migration, protrusion, expulsion and nerve damage.
Even so, Probuphine could be a suitable alternative to other MATs for certain patients. Braeburn Pharmaceuticals predicts that frequent travelers, households with children, and patients who have trouble adhering to their prescription could benefit from the implant.
On May 31, Braeburn announced its plans to release Probuphine to market in June at a cost of $4,950 for a six-month course of treatment.
Editor’s note (June 3): The original article stated the rods could leak causing overdoses. Drug dumping was not observed in any clinical trials. We apologise for any confusion this may have caused. The article has also been updated to reflect Braeburn’s May 31 press release about market release.