drugset / Press release

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

2024-10-07 · Indivior Inc. · original indivior.com ↗

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 rapid induction one hour after a single transmucosal buprenorphine dose; both of which address significant patient and healthcare provider unmet needs. - lndivior PLC (Nasdaq/LSE: INDV) today announced the Prior Approval Supplement (PAS) for SUBLOCADE• (buprenorphine extended-release) injection submitted by lndivior, Inc. has been granted Priority Review designation by the U.S. Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) action date for this submission is set for February 7, 2025. Richmond, VA, October 17, 2024 SUBLOCADE, lndivior's monthly injectable formulation of buprenorphine for the treatment of moderate to severe opioid use disorder (OUD), is the foundation of lndivior's portfolio of innovative treatments aimed at transforming how the chronic condition of OUD is managed. This PAS seeks to further expand treatment options via two proposed updates to the SUBLOCADE label, including: Alternative Injection Sites: Expands from the current subcutaneous abdominal injection site to also include the thigh, buttock, and back of the upper arm subcutaneously for induction and maintenance. Rapid Induction Protocol: Reduces treatment induction time from the current 7-day minimum on transmucosal buprenorphine (TM BUP) to a single dose of TM BUP with Allows for the second 300 mg dose to be administered as early as one week after the initial 300 mg injection, based on patient needs. Restructured the R&D and Medical Affairs organizations, including the announced closure of three related locations. lndivior's PAS included comprehensive data which we believe demonstrate the efficacy and safety of the new rapid induction protocol and SUBLOCADE's pharmacokinetic profile following injection at alternative sites. These updates are expected to enhance the patient experience and expand treatment access especially for those patients who, similar to the study participants, have long-term opioid use including fentanyl. A Priority Review designation means that the FDA's goal is to take action on an application within 6 months (compared to 10 months under standard review) and, if approved, would translate into significant improvements in OUD treatment with SUBLOCADE. About SUBLOCADE® SUBLOCADE® (buprenorphine extended-release) injection, for subcutaneous use, CIII 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 : 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. Addiction, Abuse, and Misuse : 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. Respiratory Depression : 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. Risk of Serious Injection Site Reactions : Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy. Neonatal Opioid Withdrawal Syndrome : If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. Adrenal Insufficiency : If treatment with SUBLOCADE is discontinued, monitor patients for several months for withdrawal and treat appropriately. Risk of Opioid Withdrawal with Abrupt Discontinuation : Monitor liver function tests prior to and during treatment. Risk of Hepatitis, Hepatic Events : Verify that patients have tolerated transmucosal buprenorphine before injecting SUBLOCADE. Risk of Withdrawal in Patients Dependent on Full Agonist Opioids : 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. Treatment of Emergent Acute Pain 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. Important Cautionary Note Rea:ardin1 Forward-lookin&: Statements This news release contains certain statements that are forward-looking. Forward-looking statements include, among other things, express and implied statements regarding: whether the FDA will approve the PAS which would allow us to update our label; the safety and efficacy of the new rapid induction protocol and alternative injection sites; enhanced patient experience, and expanded patient access and other 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," "guidance," 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 because they relate to future events. Various factors may cause differences between lndivior's expectations and actual results, including, among others, the fact that the regulatory approval process is uncertain and may prevent us from obtaining approvals for some or all of our product candidate; the FDA or other regulatory agencies may not agree with our regulatory approval strategies or components of our filings for our products and may not approve, or may delay the approval of, our products; and the risks described in our most recent annual report on Form 20-F beginning on page 9 as filed with the U.S. SEC and in subsequent releases. Forward-looking statements speak only as of the date that they are made and should be regarded solely as our current plans, estimates and beliefs. Except as required by law, we do not undertake and specifically decline any obligation to update, republish or revise forward-looking statements to reflect future events or circumstances or to reflect the occurrences of unanticipated events. 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 . www.indivior.com www.linkedin.com/company/Indivior 1. National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Committee on Medication-Assisted Treatment for Opioid Use Disorder, Mancher, M., & Leshner, A. I. (Eds.). (2019). Medications for Opioid Use Disorder Save Lives. National Academies Press (US). Accessed October 30, 2023 2. NIDA. 2022, March 22. Drugs and the Brain. Accessed October 30,2023, from https://nida.nih.gov/publications/drugs-brains-behavior Cassie France-Kelly VP, Communications Indivior PLC Media Enquiries: [email protected]

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