June 07, 2016

FDA Approves Implant for Opioid Dependence

, Legislation
, Network Solutions


With Thursday’s release of information attributing Prince’s death on April 21 to an opioid overdose, last week’s FDA approval of a new implant to help fight the opioid epidemic is especially timely. On May 26, the FDA approved a new implant, Probuphine, a subdermal implant of buprenorphine, after an advisory committee had previously recommended the approval in January.

“Recent high profile celebrity fatalities, such as Prince, suggest that opioid addiction knows no bounds,” said Matt Engels, Vice President of Network Solutions at CorVel. “In workers’ compensation, national studies from various sources cite that 25-30% of the medications physicians prescribe for injured workers are narcotic pain meds. Such high frequency is alarming and exposes injured workers and the system to high risk. “

According to the agency’s press release, Probuphine is the first buprenorphine implant for the maintenance of opioid dependence. It will 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.

Previously, Probuphine was available via patch and pill forms, where it effectively helped ease withdrawal symptoms. However, there were concerns for the safety of the drug in terms of abuse.

According to the FDA’s press release, “63% of Probuphine patients had no evidence of illicit opioid use during six months of treatment, which was similar to 64% who responded to sublingual buprenorphine.”

The implant presents a better way to distribute Probuphine.  The device is surgically inserted into the patient’s arm. Probuphine is a version of buprenorphine, which is classified as a Schedule III controlled substance by federal law.

Patients with opioid dependence who are already stable on a low dose of the drug will qualify for the implant. The implant must be closely monitored, and while it does have some side effects, it has minimal ability for abuse.

“Emphasis on fighting the nation’s opioid epidemic is evident from as high up as the White House. Market response and the FDA’s approval of the Probuphine implant reflects the same sentiments that safer and better solutions for this crisis are needed,” Engels said.

CorVel’s pharmacy team is trained to ensure candidates are appropriately mapped for this drug. Within our system, qualifying patients are identified in order to effectively mitigate risks.

In addition to CorVel’s integrated system and state formulary management, the Probuphine implant is a new tool to strengthen their efforts to combat the opioid epidemic within the workers’ compensation industry. As part of their pharmacy program, CorVel enforces state guidelines, refers patients to clinical intervention when necessary, and also is aware of indicators which may suggest psychosocial contributing factors.

Learn more on CorVel’s website or contact a CorVel associate if you have questions about the implant.