Buprenorphine Hydrochloride

TUESDAY, Feb. 25, 2025 -- More emergency room doctors in California are prescribing the anti-addiction medication buprenorphine , contributing to the state’s battle against the U.S. opioid epidemic, a new study suggests. About 16% of scrips written for buprenorphine in California came from an ER doctor in 2022, up from only 2% in 2017, researchers reported recently in the Journal of the American Medical Association . More ER docs also started patients on buprenorphine treatment, with initial prescriptions written by emergency doctors increasing from 0.1% to 5% during the same period, results show. “We're seeing this huge shift of prescriptions over a five-year period -- the efforts are working,” lead researcher Dr. Annette Dekker , an assistant professor of emergency medicine at UCLA, said in a news release. This increase is part of an initiative in California called CA Bridge, which since 2019 has worked with more than 80% of the state’s hospitals to make it easier for an ER patient to get a buprenorphine prescription, researchers said in background notes. “For a lot of people who use opioids, the emergency department might be the only touch point they have with the healthcare system, so it’s a huge window of opportunity to make a difference,” Dekker said. Buprenorphine binds to opioid receptors in the brain, reducing a person’s cravings for narcotics without producing the euphoric feeling that opioids induce, researchers said. Despite its effectiveness, an estimated 87% of people with opioid use disorder are never prescribed buprenorphine or any medication to help them fight their addiction, researchers noted. The CA Bridge program aimed to change that by training ER staff on the use of buprenorphine to treat opioid addiction, they said. The program also provides navigators to help ER patients find community treatment programs, through which they can keep taking buprenorphine initially prescribed in the ER. For this study, researchers analyzed records on more than 345,000 patients who received 3.8 million prescriptions for buprenorphine from nearly 22,000 doctors in California between 2017 and 2022. The number of emergency doctors who prescribed buprenorphine for the first time increased from 70 in 2017 (3%) to 941 in 2022 (25%), results show. Likewise, the number of patients receiving their first buprenorphine prescription from an ER doc increased from 46 in 2017 to 3,289 in 2022. An ER doctor’s intervention helped many patients step onto the road to recovery, researchers found. About 1 in 3 of these patients went on to receive a second prescription of buprenorphine, and 1 in 9 got at least six months of continuous buprenorphine treatment, the study says. “These data strongly suggest a long-term beneficial impact from emergency department-prescribed buprenorphine for opioid use disorder,” co-researcher Dr. Andrew Herring , program director of the Bridge Center at the Public Health Institute in Oakland, Calif., said in a news release. “To observe that for every nine patients who start buprenorphine treatment in an emergency department, one achieves six months of continuous treatment within the next year is simply remarkable,” Herring added. “It is a call to action that buprenorphine should be an expected standard of care in all emergency departments in every state.” These results show that with “adequate state investments, Emergency Departments can play a crucial role for patients with opioid addiction -- being available as a safety net 24 hours a day, 365 days a year, and providing pivotal steps in the cascade of care,” says an accompanying editorial co-written by Dr. Gail D’Onofrio , a professor of emergency medicine at Yale School of Medicine. “California provides a model and blueprint for other states to follow for both urban and rural areas as we continue to fight this epidemic,” the editorial concluded. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

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) RICHMOND, Va., Feb. 24, 2025 /PRNewswire/ -- Indivior PLC (Nasdaq/LSE: INDV), a global leader in addiction treatment, today announced that the U.S. Food and Drug Administration (FDA) has approved label changes for SUBLOCADE® including a rapid initiation protocol and alternative injection sites, marking a significant advancement in the treatment of moderate to severe opioid use disorder (OUD). Key Label Changes Include: Rapid initiation Protocol: Healthcare providers can now initiate treatment with SUBLOCADE after a single dose of transmucosal buprenorphine and a one-hour observation period to confirm tolerability.1,2 Alternative Injection Sites: SUBLOCADE can now be administered subcutaneously in the abdomen, thigh, buttock, or back of the upper arm, offering patients and healthcare providers increased flexibility in treatment administration2. These FDA label changes can provide important benefits for patients and healthcare providers. Rapid initiation may lessen some of the practical obstacles to treatment induction, which may increase the likelihood that patients and providers will start therapy quickly, thereby shortening the time to achieve SUBLOCADE's therapeutic levels that provide continuous buprenorphine concentrations above 2ng/mL.3 Additionally, the ability to select a different injection site may provide patients more flexibility so that they may be inclined to continue their treatment. More options for healthcare providers to administer SUBLOCADE will streamline the course of treatment and improve integration into different healthcare environments. "These label updates for SUBLOCADE underscore our dedication to evolving our treatment options to better serve individuals battling opioid use disorder," said Dr. Christian Heidbreder, Ph.D., Chief Scientific Officer at Indivior. "These enhancements not only reflect our commitment to patient-centered care but also our ongoing efforts to align our treatments with real-world clinical needs, thereby potentially improving patient adherence and outcomes." Indivior is committed to empowering patients on their path to recovery by providing treatments that are both effective and tailored to their medical needs. These label changes do not alter the well-established safety profile or the efficacy of SUBLOCADE and the medication continues to offer an effective treatment option for OUD while being more adaptable to patient medical needs. The non-inferiority study supporting rapid induction with SUBLOCADE was conducted across multiple sites, included 729 participants (mean age 40.7, average opioid use of 15 years)1, and was stratified by fentanyl presence in urine screens. At induction 77.5% of patients were fentanyl-positive. Patients were randomized at a 2:1 ratio to rapid initiation [received a single dose of 4 mg transmucosal buprenorphine (TM-BUP), followed by a SUBLOCADE injection within one hour] or to a standard induction (daily TM-BUP over ≥7 days) before receiving injection 1. Rapid induction was effective, shown by the primary endpoint of participant retention at the second injection. The proportion of participants who received the second injection was 66.4% in the rapid induction arm and 54.5% in the standard induction arm2. 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 . 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.4 OUD may affect the parts of the brain that are necessary for life-sustaining functions.4 About Indivior Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD). Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. Indivior is dedicated to transforming SUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs over 1,000 individuals globally and its portfolio of products is available in over 30 countries worldwide. Visit to learn more. Connect with Indivior on LinkedIn by visiting . References Data on File. Indivior Inc. North Chesterfield, VA. SUBLOCADE (buprenorphine extended-release) injection, for subcutaneous use [package insert]. North Chesterfield, VA: Indivior PLC; 2025. Jones AK, Ngaimisi E, Gopalakrishnan M, Young MA, Laffont CM. Population Pharmacokinetics of a Monthly Buprenorphine Depot Injection for the Treatment of Opioid Use Disorder: A Combined Analysis of Phase II and Phase Ill Trials. Clin Pharmacokinet. 2021;60(4):527-540. doi:10.1007/s40262-020-00957-0. NIDA. 2022, March 22. Drugs and the Brain. Accessed October 30,2023, from 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