Bobby Mukkamala, MD

Mukkamala discussed other priorities the AMA’s Substance Use and Pain Care Task Force is tackling with OUD.

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.

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.

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.

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.

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.

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 

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

Videos

Mukkamala also discussed the importance of expanding non-opioid pain relief options.

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.

The news comes almost 1 year after its initial approval for treating treat moderate to severe OUD

 and expands the approved subcutaneous injection site of the abdomen to the thigh, buttock, and back of the upper arm for induction and maintenance.

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.

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.

“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.

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

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 

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.

Bobby Mukkamala, MD

Articles