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Probuphine implant could be a new option for addicts if obstacles, such as price, don’t get in the way.
Amid the U.S. opioid epidemic, industry watchers have been waiting for the FDA approval of the implant for opioid addicts.
Probuphine (Titan Pharmaceuticals and Braeburn Pharmaceuticals), is the first buprenorphine implant to be approved for the maintenance treatment of opioid dependence. Probuphine is designed to provide a constant, low-level dose of buprenorphine for six months in patients who are already stable on low-to-moderate doses of other forms of buprenorphine, as part of a complete treatment program.
Until today, buprenorphine for the treatment of opioid dependence was only approved as a pill or a film placed under the tongue or on the inside of a person’s cheek until it dissolved.
“Because it's an implant, Probuphine can't easily be diverted and sold to addicts, who sometimes abuse the medications designed to help patients recover from addiction just as they do other, stronger opioids,” says Managed Healthcare Executive Editorial Advisor Joel V. Brill, MD, chief medical officer, Predictive Health LLC. “It also takes human error out of the equation-each implant is left in place for six months so patients can't forget to take the drug or take too much of the drug.”
In January, FDA advisors recommended the approval of this drug.
One stumbling block to its approval may be the price, according to Brill.
The manufacturer plans to price it on par with other injectable treatments for opioid addicts, some of which cost $1,000 per month, NPR reports.
Another obstacle could be the number of doctors that can prescribe the drugs, according to Brill.
“Doctors need special permission to prescribe opioid replacement therapies and federal law only lets doctors treat 100 patients at a time, leaving the medicines out of reach for many,” he says. “Lawmakers considered raising the 100-patient limit in opioid legislation now in conference committee, but neither the House nor Senate passed a measure to do so.”
Probuphine implants are analogous to contraception products-i.e., Depo-Provera-in their application or long-term delivery system to assure urge suppression is in a patients’ system as part of the treatment for drug addiction, explains Randy Vogenberg, partner, Access Market Intelligence and National Institute of Collaborative Healthcare.
“Similar to smoking cessation, this implant product has to be part of a broader or holistic therapeutic approach over a long enough period of time to have a successful outcome,” Vogenberg says.