New Buprenorphine Label Allows Physician-Informed Treatment of Opioid Use Disorder, with Bobby Mukkamala, MD

The FDA approved the prior supplement submission for Indivior’s buprenorphine extended-release injection (SUBLOCADE) to treat opioid use disorder (OUD) this past Monday, February 24, 2025.¹

The news comes almost 1 year after its initial approval for treating treat moderate to severe OUD² and expands the approved subcutaneous injection site of the abdomen to the thigh, buttock, and back of the upper arm for induction and maintenance.¹

Notably, the updated label also reduces treatment induction time from the current 7-day minimum on transmucosal buprenorphine to a single dose of transmucosal buprenorphine with a 1-hour observation period to confirm tolerability and allows patients 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 why the labeling change is an important step in treating OUD. He also stressed the importance of adding more non-opioid pain management strategies to the market, such as suzetrigine, which was approved in January 2025.³

“Everything changes from year to year, and that number needs to change if we're going to be able to take care of our patients. And that's something that a physician will decide, because they know the patient. They know what the use history is. They know what the need for treatment is, and the amount of that need, is it 24 milligrams? Is it 32 milligrams? That's something that shouldn't be limited by regulations. It should be the decision of the physician,” Mukkamala said.

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 February 24, 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 February 5, 2025.

3. Office of the Commissioner. FDA approves novel non-opioid treatment for moderate to severe acute pain. U.S. Food and Drug Administration. January 30, 2025. Accessed January 30, 2025. https://www.fda.gov/news-events/press-announcements/fda-approves-novel-non-opioid-treatment-moderate-severe-acute-pain.