Indivior PLC reported that a randomized, double‑blind study of its extended‑release buprenorphine product, SUBLOCADE®, published in JAMA Network Open on December 17, 2025, found that both 100‑mg and 300‑mg monthly maintenance doses rapidly reduced opioid use. Participants dropped from more than 43 uses per week at screening to fewer than three uses per week by week three, and the reduction was sustained through week 38. Abstinence rates were higher in the 300‑mg group among patients who used fentanyl daily or 14 or more times per week, while injection‑site reactions were more common in the 300‑mg arm but remained mild to moderate and did not lead to discontinuation.
The findings underscore SUBLOCADE® as a flexible, high‑dose option that can address the needs of patients with severe opioid use disorder, particularly those in the fentanyl‑era. By demonstrating greater abstinence benefits for a subset of patients, the trial provides evidence that could influence dosing guidelines, payer coverage decisions, and clinical practice recommendations, potentially expanding the drug’s market penetration and reinforcing its competitive position in the OUD treatment landscape.
Chief Scientific Officer Christian Heidbreder said, "These findings offer evidence to consider for clinicians navigating the complexities of OUD in the fentanyl era. By demonstrating that extended‑release buprenorphine improves abstinence, even among those with high‑frequency fentanyl use, we underscore the need for treatment approaches that adapt to the realities of today’s opioid crisis and give patients the best chance at recovery."
Indivior has been simplifying its business and focusing on SUBLOCADE® growth, and this trial represents a key milestone in that strategy. The data reinforce the company’s commitment to providing high‑quality, evidence‑based treatment options for patients with the most severe forms of opioid use disorder, and they may support future regulatory and payer discussions that could broaden access to the drug.
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