The Shifting Field of Care of Opioid Use Disorder, with Bobby Mukkamala, MD

Last month, the FDA approved the prior supplement submission for Indivior’s buprenorphine extended-release injection (SUBLOCADE) to treat opioid use disorder (OUD) almost 1 year after its initial approval for treating treat moderate to severe OUD.1,2

The new labeling expands the approved subcutaneous injection site of the abdomen to the thigh, buttock, and back of the upper arm for induction and maintenance.1 In another shift, the current 7-day minimum on transmucosal buprenorphine will be amended to a single dose of transmucosal buprenorphine with a 1-hour observation period to confirm tolerability and patients will be allowed to receive a second 300 mg dose 1 week after the initial 300 mg injections.

HCPLive spoke with otolaryngologist Bobby Mukkamala, MD, who is serving as president-elect of the American Medical Association (AMA) and chair of the AMA’s Substance Use and Pain Care Task Force, to learn more about the labeling change. He also shared other priorities in the shifting world of care for OUD.

“We would really encourage folks that are trying to take care of their communities and trying to take care of their patients to look and see what comes from our task force. It's a very useful, but one of many sources of knowledge so we can take better care of our communities and our patients,” Mukkamala said.

Conversations about supporting treatment for OUD are especially pertinent as Congress just a couple of days ago failed to address payment cuts imposed in the CY25 Medicare Physician Fee Schedule (MPFS), comprising care for vulnerable patient populations.

Mukkamala has no relevant disclosures to report.

REFERENCES

1. Indivior Announces FDA Approval of Label Changes for SUBLOCADE® (buprenorphine extended-release) Injection. PR Newswire. February 24, 2025. https://www.prnewswire.com/news-releases/indivior-announces-fda-approval-of-label-changes-for-sublocade-buprenorphine-extended-release-injection-302382920.html. Accessed March 17, 2025.

2. Braeburn's BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection (CIII) Receives FDA Approval for Moderate to Severe Opioid Use Disorder. PR Newswire. May 23, 2023. https://www.prnewswire.com/news-releases/braeburns-brixadi-buprenorphine-extended-release-subcutaneous-injection-ciii-receives-fda-approval-for-moderate-to-severe-opioid-use-disorder-301832521.html Accessed March 17, 2025.

3. Congress Fails to Address Medicare Fee Schedule in Continuing Resolution. News release. American Physical Therapy Association. March 17, 2025. https://www.apta.org/news/2025/03/17/congress-fails-to-address-fee-schedule