- The U.S. Food and Drug Administration moved last Thursday to approve a new form of treatment for patients addicted to heroin and opioid painkillers.
- The device, Probuphine, is an implant that provides a long-acting release of buprenorphine to reduce cravings and withdrawal symptoms for six months.
- The implant, designed to help patients avoid missing doses (or selling them) and relapsing, is expected to become available by late June.
The FDA had previously rejected Probuphine in 2012 over concerns--that some experts maintain--that the daily dose it delivers is too low for a large proportion of patients. It provides one 8mg dose of buprenorphine per day, while physicians may prescribe a range of 4 to 24mg depending on the patient's needs, reported NPR.
However, since its initial refusal of the device, the FDA has faced increasing pressure to help solve the nation's opioid crisis, and it responded positively when Probuphine manufacturer Braeburn Pharmaceuticals and partner Titan Pharmaceuticals resubmitted the device for approval. In addition, the manufacturers specify that Probuphine is designed for patients already stabilized on low-to-moderate doses of oral buprenorphine, and as part of a complete treatment program.
"We must do everything we can to make new, innovative treatment options available that can help patients regain control over their lives," FDA commissioner Dr. Robert Califf stated.
Questions remain about whether insurers will cover the device, which costs about $825 a month compared to $130 to $190 for pills.