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Indivior's SUBLOCADE® Rapid Induction/Alternative Injection Site Prior Approval Supplement (PAS) Receives FDA Priority Review

PDUFA date set for February 7, 2025 If approved by the FDA, label would expand to include alternative injection sites in the thigh, buttock and back of the arm for induction and maintenance as well as ...
Seeking Alpha

Rapid Initiation with Once-monthly SUBLOCADE® Superior to Standard Initiation for Treating Opioid Use Disorder, Including in Fentanyl-Positive Patients, According to Data ...

Data show rapid initiation with once-monthly SUBLOCADE significantly improves retention in opioid use disorder (OUD) patients, especially among fentanyl-positive participants. Study also administered ...
Morningstar

Clinical Evidence Supports Rapid SUBLOCADE® Induction as a Strategy to Improve Retention in Opioid Use Disorder Treatment

RICHMOND, Va., Oct. 15, 2025 /PRNewswire/ -- Indivior PLC (Nasdaq: INDV) this week published compelling results from a multicenter, open-label clinical trial published in JAMA Network Open. Two ...
WGNO

Indivior Highlights Growing Body of Data on SUBLOCADE® (buprenorphine once-monthly extended-release injection) Helping Patients Achieve Long-Term Recovery from Opioid Use ...

Evidence demonstrates that SUBLOCADE supports long-term recovery from opioid use disorder (OUD) and is effective and safe. Publications highlight the importance of overcoming access barriers to ...
ksn.com

Indivior Announces FDA Approval of Label Changes for SUBLOCADE® (buprenorphine extended-release) Injection

Rapid Initiation Protocol Reduces Time to Treatment with SUBLOCADE ® From One Week to One Hour, A Significant Advancement in the Treatment of Moderate to Severe Opioid Use Disorder (OUD) These FDA ...
Nasdaq

Indivior: FDA Approval Of SUBLOCADE Label Changes Delayed

(RTTNews) - Indivior PLC (INDV, INDV.L), a specialty pharmaceutical company, announced Wednesday that the U.S. Food and Drug Administration has informed that the final review of the SUBLOCADE ...
Morningstar

New Study Shows Extended-Release Buprenorphine Safely Delivers Rapid, Clinically Meaningful Reductions in Opioid Use and Supports Abstinence in High-Risk Populations

Both monthly maintenance doses (100 mg and 300 mg) improved opioid abstinence and were well-tolerated with no new safety signals identified. Post-hoc analyses indicated the 300-mg monthly maintenance ...