Buprenorphine

Rapid induction with SUBLOCADE® showed higher treatment retention rates compared to standard induction, particularly among fentanyl-positive participants Richmond, VA – October 15, 2025 – Indivior PLC (Nasdaq: INDV) this week published compelling results from a multicenter, open-label clinical trial published in JAMA Network Open. Two approaches were evaluated for initiating treatment with SUBLOCADE®, extended-release buprenorphine, in individuals who met criteria for moderate-to-severe opioid use disorder (OUD) and who engage in high-risk opioid use—including injection use, high-dose consumption, or fentanyl use. The study found that rapid induction—administration of a single dose of 4-mg oral buprenorphine followed by a same-day SUBLOCADE injection—was well tolerated and led to higher retention at the second injection compared to standard induction, which is at least seven days of oral buprenorphine dose adjustments prior to the first injection of SUBLOCADE. These benefits were observed across the full study population and were especially pronounced among fentanyl-positive participants, addressing the clinically relevant outcome that patients remain engaged with treatment after induction. The trial also demonstrated that administering the second SUBLOCADE injection just one week after the first was well tolerated in both treatment arms as the safety profile up to injection two was comparable, reinforcing the potential for an agile and patient-centered treatment model with rapid induction. A similar proportion of participants in adverse events up to injection two. “This study represents a pivotal advancement for both patients and clinicians confronting opioid use disorder in the fentanyl era,” said Christian Heidbreder, Ph.D., Chief Scientific Officer at Indivior. “The demonstration that rapid, same-day induction onto SUBLOCADE is not only effective but also well tolerated is opening a critical window of opportunity to keep high-risk patients with moderate-to-severe OUD engaged in care during their most vulnerable early weeks of treatment.” Study limitations include its open-label design, which could introduce some reporting bias, although there was no evidence of patient and provider preference for either strategy. About SUBLOCADE®    SUBLOCADE® (buprenorphine extended-release) injection, for subcutaneous use, CIII    INDICATION AND HIGHLIGHTED SAFETY INFORMATION    INDICATION    SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine.    SUBLOCADE should be used as part of a complete treatment plan that includes counseling and psychosocial support.    HIGHLIGHTED SAFETY INFORMATION    WARNING: RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS ADMINISTRATION; SUBLOCADE RISK EVALUATION AND MITIGATION STRATEGY  Serious harm or death could result if administered intravenously. SUBLOCADE forms a solid mass upon contact with body fluids and may cause occlusion, local tissue damage, and thrombo-embolic events, including life-threatening pulmonary emboli, if administered intravenously.  Because of the risk of serious harm or death that could result from intravenous self-administration, SUBLOCADE is only available through a restricted program call the SUBLOCADE REMS Program. Healthcare settings and pharmacies that order and dispense SUBLOCADE must be certified in this program and comply with the REMS requirements.  CONTRAINDICATIONS    Hypersensitivity to buprenorphine or any other ingredients in SUBLOCADE.    WARNINGS AND PRECAUTIONS    Addiction, Abuse, and Misuse: SUBLOCADE contains buprenorphine, a Schedule III controlled substance that can be abused in a manner similar to other opioids. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors.    Respiratory Depression: Life threatening respiratory depression and death have occurred in association with buprenorphine. Warn patients of the potential danger of self-administration of benzodiazepines or other CNS depressants while under treatment with SUBLOCADE.    Risk of Serious Injection Site Reactions: Likelihood of may increase with inadvertent intramuscular or intradermal administration. Evaluate and treat as appropriate. The most common injection site reactions are pain, erythema and pruritus with some involving abscess, ulceration and necrosis.  Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy.  Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid.    Risk of Opioid Withdrawal with Abrupt Discontinuation: If treatment with SUBLOCADE is discontinued, monitor patients for several months for withdrawal and treat appropriately.  Risk of Hepatitis, Hepatic Events: Monitor liver function tests prior to and during treatment.    Risk of Withdrawal in Patients Dependent on Full Agonist Opioids: Verify that patients have tolerated transmucosal buprenorphine before injecting SUBLOCADE.    Treatment of Emergent Acute Pain: Treat pain with a non-opioid analgesic whenever possible. If opioid therapy is required, monitor patients closely because higher doses may be required for analgesic effect.    ADVERSE REACTIONS    Adverse reactions commonly associated with SUBLOCADE (in ≥5% of subjects) were constipation, headache, nausea, injection site pruritus, vomiting, increased hepatic enzymes, fatigue, and injection site pain.    For more information about SUBLOCADE, the full Prescribing information including BOXED WARNING, and Medication Guide, visit www.sublocade.com.    About Opioid Use Disorder (OUD)  Opioid Use Disorder (OUD) is a chronic disease in which people develop a pattern of using opioids that can lead to negative consequences. OUD may affect the parts of the brain that are necessary for life-sustaining functions.     About Indivior  Indivior is a pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a human crisis to a recognized and treated chronic disease. Building on its portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/Indivior.

RICHMOND, Va., Oct. 1, 2025 /PRNewswire/ -- Indivior PLC (Nasdaq: INDV) (" Indivior PLC" or the " Company") today announced that it intends to pursue a change in domicile from the U.K. to the U.S. and will establish a new U.S. parent company, Indivior Pharmaceuticals, Inc. (IPI), above its existing U.K. parent company. This follows Indivior's U.S. listing on the Nasdaq Stock Exchange (" Nasdaq") in June 2023 and subsequent cancellation of its secondary listing on the London Stock Exchange in July 2025. Indivior's board of directors is recommending the proposed change in domicile of the parent company of the Indivior group (the " Group") to maximize the benefits of its U.S. stock listing, including: Expanding Indivior's U.S. capital markets presence Increasing potential U.S. equity indexation Simplifying corporate governance and reducing complexity Further positioning Indivior as a U.S. based treatment innovator, enabling closer collaboration with public health leaders on advancing SUBLOCADE® for opioid use disorder Transaction Process & Timeline Indivior intends to implement the redomiciliation by means of a U.K. court-sanctioned scheme of arrangement (the " Scheme"). Subject to the approval of Indivior's shareholders, following the effectiveness of the Scheme, Indivior PLC will become a direct wholly owned subsidiary of IPI, a new Delaware corporation. IPI's common stock will be listed on Nasdaq and will continue to trade under the symbol INDV. Shareholders of Indivior PLC will receive one new IPI share for each Indivior PLC share held as of the scheme record date. Indivior PLC shares will be cancelled at the time shareholders receive their new shares of IPI. No additional equity will be raised by IPI as part of the transaction. The Scheme requires a formal vote by Indivior PLC shareholders at an extraordinary general meeting (" EGM") to be approved by a majority in number of Indivior PLC shareholders voting in person or by proxy and representing 75% in value of the shares voted. The timeline for the transaction is expected to be: Mid November 2025: Shareholder circular including the notice of EGM issued to shareholders Early December 2025: EGM held in London Late January 2026: Effective date of the Scheme; Indivior PLC shares exchanged for IPI shares; IPI shares begin trading on Nasdaq No action is needed by shareholders at this time. Additional Information Forthcoming Further details about the Scheme and any expected impacts on the Company and its shareholders will be provided in the shareholder circular, which will include a notice for the special meeting. Important Information for Investors and Shareholders This communication does not constitute an offer to sell or the solicitation of an offer to buy or exchange any securities or a solicitation of any vote or approval in any jurisdiction. It does not constitute a prospectus or prospectus equivalent document. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended, or by means of a transaction exempt from such registration requirements. Investors and security holders will be able to obtain free copies of the shareholder circular (when available) and other documents filed with the U.S. Securities and Exchange Commission (the " SEC") by the Company regarding the redomiciliation and the Scheme through the website maintained by the SEC at . Copies of the documents filed with the SEC by the Company will be available free of charge on Company's website at under the tab "Investors" and under the heading "SEC Filings" or by contacting the Company's Company Secretary by email at [email protected]. Important Cautionary Note Regarding Forward-looking Statements Certain statements contained herein are forward-looking statements." Forward-looking statements include, among other things, express and implied statements pertaining to (i) our intentions with respect to the redomiciliation and our expectation that it will become effective; (ii) expected future sources of shareholder value, (iii) expected benefits of the redomiciliation, (iv) estimates of costs and complexity of maintaining a secondary listing, and (v) statements containing the words "believe", "anticipate," "plan," "expect," "intend," "estimate," "forecast," "strategy," "target," "guidance," "outlook," "potential," "project," "priority," "may," "will," "should," "would," "could," "can," "outlook," the negatives thereof, and variations thereon and similar expressions. By their nature, forward-looking statements involve risks and uncertainties as they relate to events or circumstances that may or may not occur in the future. Actual results may differ materially from those expressed or implied in such statements because they relate to future events, will require court and shareholder approval which may not be obtained, or involve the actions of third parties beyond the Company's control. For information about some additional risks and important factors that could affect our future results and financial condition, see the discussion of "Risk Factors" in our Annual Report on Form 10-K filed March 3, 2025, our Forms 10-Q filed May 1, 2025 and July 31, 2025, and our other filings with the SEC. We have based the forward-looking statements in this release on our current expectations and beliefs concerning future events. Forward-looking statements contained in this release speak only as of the day they are made and, except as required by law, we undertake no obligation to update or revise any forward-looking statement. About Indivior Indivior is a pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a human crisis to a recognized and treated chronic disease. Building on its portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Visit  to learn more. Connect with Indivior on LinkedIn by visiting . SOURCE Indivior PLC WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED