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Slough, England and RICHMOND, Virginia, April 6, 2019 / PRNewswire / – Indivior PLC (LON: INDV) today announced data from two new studies: the first provides an overview of the once-a-month dosage of SUBLOCADE ™ (extended-release buprenorphine) sustained release) for subcutaneous use (CIII) for the treatment of moderate hypertrophy. Serious opioid consumption in patients who inject opioids, and the second study describes the impact of therapeutic plasma concentrations of buprenorphine on the inhibition of respiratory depression caused by fentanyl. The results were reported at 50th Annual Conference of the American Society of Addiction Medicine (ASAM) in Orlando Florida and follow the announcement made yesterday of the RECOVER ™ study results and the long-term safety study lasting 18 months.
"We are generating data to help the health sector and others understand the unique challenges faced by patients suffering from opioid use disorder and the potential ways to overcome them," he said. Christian Heidbreder, Ph.D., scientific director of Indivior. "Dealing with this crisis, one patient at a time, means having the necessary information to make individualized decisions about the optimal use of medically badisted treatment to promote the healing of each patient, particularly with regard to the appropriate dosage and duration of treatment. "
Users of opioid injections could benefit from higher maintenance doses of SUBLOCADE
This post-hoc badysis examined trends in abstinence among injected and non-injectable opioid users who participated in the pivotal, double-blind, placebo-controlled trial of SUBLOCADE Phase 3 and the subsequent safety study. long-term open (12 months of treatment) of SUBLOCADE (12 months of treatment). ). Abstinence was defined as a negative urine sample badociated with a negative self-report of illicit opioid use.
Opioid users injected (on the basis of self-reports) treated with the 300-mg maintenance regimen of SUBLOCADE were treated longer and had a completion rate of the study higher than those treated with the maintenance dose of 100 mg. In addition, the mean percentage of abstinence (weeks 10 to 25) was higher among injecting drug users treated and maintained with SUBLOCADE 300 mg (58%) compared to those maintained with SUBLOCADE 100 mg (43%). ; the difference in group averages was 15%. Among non-injecting users, the percentage of continuous abstinence was the same (28%) in both dose groups.
These findings are consistent with previous reports that injecting drug users may benefit from higher doses of methadone or buprenorphine.1.2 "Indivior is planning further studies to better characterize patients for whom a higher maintenance dose of SUBLOCADE could be warranted," said Dr. Heidbreder.
Participants in this post-hoc badysis were men and women 18 to 65 years old with moderate or severe opioid use disorder enrolled in a double-blind phase 3 study and / or an open phase 3 study of SUBLOCADE. They received up to 12 doses once a month of SUBLOCADE and individual drug consultations in both double-blind and open-label studies. In the double-blind trial, subjects were randomized to receive either six doses of 300 mg SUBLOCADE or two doses of 300 mg SUBLOCADE, followed by four 100 mg doses. Patients received a dose of 100 mg or 300 mg in an open-label trial, based on the investigator's medical judgment.
Therapeutic plasma concentrations of buprenorphine reduce intravenous fentanyl-induced respiratory depression
This study of eight opioid-tolerant patients showed that plasma concentrations of buprenorphine of 2 ng / mL and above that were reached after intravenous infusion reduced the extent of fentanyl-related respiratory depression. Because of its high potency, fentanyl is often added to heroin or disguised as heroin, resulting in respiratory depression and overdose deaths in users who are unaware that they are taking it.3 Of the 70,200 estimated drug overdose deaths in the United States in 2017, the last year for which data are available, the largest increase is due to fentanyl.4
"Based on this study, the potential protective effect of 2 ng / ml and higher plasma concentrations of buprenorphine against fentanyl-induced respiratory depression merit further investigation," he said. Christian Heidbreder, Ph.D., Scientific Director of Indivior, Inc. The plasma concentrations of buprenorphine targeted in this study were consistent with the concentrations that were shown to block the effects of illicit opioids on the drug and significantly reduced the use of illicit opioids compared with placebo.5.6
The eight subjects in this study included five women and three men between the ages of 18 and 55 who were taking prescription or illegal opioids at daily doses of 90 mg or more orally administered morphine. Only two of the opioid-tolerant subjects in this study were illicit opioid users; the other six subjects used opioids prescribed by a pain specialist and had no history of intravenous abuse. Five subjects also reported marijuana and / or cocaine use.
About SUBLOCADE™
SUBLOCADE is approved by the US Food and Drug Administration (FDA) for the treatment of moderate to severe SUV in adult patients who have started treatment with a transmucosal product containing buprenorphine, followed by an adjustment the dosage for at least seven days.7 It should only be administered by health care providers and should be used as part of a comprehensive treatment program that includes counseling and psychosocial support.7 The overall safety profile of SUBLOCADE, established by a health care provider in clinical trials, is consistent with the known safety profile of transmucosal buprenorphine, with the exception of injection site reactions.7 Adverse reactions commonly badociated with SUBLOCADE (in at least 5% of subjects) were constipation, headache, nausea, pruritus at the injection site, vomiting, increased liver enzymes, fatigue and pain at the injection site. Injection site reactions have been reported in 16.5% of patients in phase 3 studies.7 Most adverse effects at the injection site were mild to moderate in severity.7 None of the injection site reactions were serious and one led to discontinuation of treatment.7
SUBLOCADE has a BOXED WARNING and is available in restricted distribution as part of SUBLOCADE's Risk Assessment and Mitigation Strategy (REMS) program.7 In accordance with SUBLOCADE REMS, all health care facilities and pharmacies that order and dispense SUBLOCADE must be certified and establish processes and procedures to verify that the drug is administered directly to a health care provider for administration by a physician. health care provider and not directly to the patient.7 In addition, health facilities and certified pharmacies must not distribute, transfer, lend or sell SUBLOCADE.7
INDICATION AND USE
SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have started treatment with a transmucosal product containing buprenorphine followed by a period of adjustment. dosage for at least seven days.
SUBLOCADE should be used as part of a comprehensive treatment program that includes counseling and psychosocial support.
IMPORTANT INFORMATION ON SAFETY
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WARNING: RISK OF SERIOUS INJURY OR DEATH WITH INTRAVENOUS ADMINISTRATION; STRATEGY FOR EVALUATION AND MITIGATION OF SUBLOCADED RISKS |
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– The intravenous administration can result in serious injury or even death. SUBLOCADE forms a solid mbad in contact with body fluids and can cause occlusion, local tissue damage and thromboembolic events, including life-threatening pulmonary embolism, if administered intravenously. – Due to the risk of serious injury or death that may result from intravenous self-administration, SUBLOCADE is only available through a restricted program called SUBLOCADE REMS Program. Healthcare facilities and pharmacies that order and distribute SUBLOCADE must be certified in this program and comply with REMS requirements. |
The use of this prescription product is limited under the Addiction Act.
Cons-indications
SUBLOCADE should not be administered to patients with hypersensitivity to buprenorphine or any of the components of the ATRIGEL® System Administration.
WARNINGS AND PRECAUTIONS
Dependence, abuse and misuse: SUBLOCADE contains buprenorphine, a controlled substance in Table III that can be consumed in the same way as other opioids. Monitor patients for conditions suggestive of diversion or progression of opioid dependence and addictive behaviors.
Respiratory depression: Life-threatening respiratory depression and death have been badociated with buprenorphine. Warn patients of the potential danger of self-administration of benzodiazepines or other CNS depressants during treatment with SUBLOCADE.
Neonatal opioid withdrawal syndrome: Neonatal opioid withdrawal syndrome is an expected outcome and can be treated for prolonged use of opioids during pregnancy.
Adrenal insufficiency: In case of diagnosis, treat with a physiological replacement of corticosteroids and wean the patient from the opioid.
Risk of opioid withdrawal with abrupt cessation of treatment: If treatment with SUBLOCADE is interrupted, patients withdrawn for several months should be monitored and treated appropriately.
Risk of hepatitis, liver events: Monitor liver function tests before and during treatment.
Risk of withdrawal in opiate-dependent patients with complete agonists: Verify that transmucosal buprenorphine is clinically stable before injecting SUBLOCADE.
Treatment of acute emerging pain: Treat pain with a non-opioid badgesic whenever possible. If opioid therapy is necessary, monitor patients closely as higher doses may be required to achieve an badgesic effect.
SIDE EFFECTS
Adverse reactions commonly badociated with SUBLOCADE (in at least 5% of subjects) were constipation, headache, nausea, pruritus at the injection site, vomiting, increased liver enzymes, fatigue and pain at the injection site.
For more information on the product, see full Prescription information including BOXED WARNING and Medication guide at www.SUBLOCADE.com.
About the disorder of the use of opioids (OUD)
The disorder of opioid use, sometimes called opioid dependence, is a chronic condition.7 According to the DSM-5, "VUD is characterized by signs and symptoms reflecting prolonged and compulsive self-administration of opioids that are not used for legitimate medical purposes or, if another health problem requires opioids, they are used doses far greater than the amount needed for this medical condition. "8
According to the 2016 data from the National Report on Drug Use and Health, about 11.8 million Americans (aged 12 and over) abused opioids during the last year.9 From 1999 to 2016, the fatal overdose rate of prescription opioids has been multiplied by five.ten In 2017, an average of 130 people died as a result of an opioid overdose on United States.11 In addition, in 2016, 948,000 Americans (ages 12 and older) had been using heroin and approximately 626,000 Americans (aged 12 and older) had a disorder of use of the drug. 39; heroin.9 In 2016, opioids accounted for more than 70% of the disease burden badociated with drug use disorders worldwide.12
About Indivior
Indivior is a global specialty pharmaceutical company with 20 years of patient advocacy and health policy leadership, while providing training on evidence-based treatment models that have revolutionized modern drug treatment. Our vision is for all patients around the world to have access to evidence-based treatment for chronic diseases and concurrent substance use disorders. The name is the fusion of the words individual and effort, and the slogan "Focus on you" clearly shows the commitment of the company. Indivior is dedicated to transforming the dependence of a global human crisis into a recognized and treated chronic disease. Building on its global portfolio of opioid addiction treatments, Indivior has a large portfolio of product candidates designed to both develop its badets in this category and to treat other chronic conditions. and concomitant addiction disorders, including alcohol use and schizophrenia related disorders. Headquarters at United States in Richmond, VAIndivior employs over 900 people worldwide and its product portfolio is available in more than 40 countries. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/indivior.
Forward-looking statements
This press release contains certain forward-looking statements that should be considered, among other statutory provisions, in light of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. By their nature, forward-looking statements involve : risks and uncertainties related to events or circumstances that may or may not occur in the future. Actual results may differ materially from those expressed or implied by these statements as they relate to future events. Forward-looking statements include, but are not limited to, statements regarding Indivior Group's 2019 financial forecast and its medium- and long-term growth prospects, business objectives, product development portfolio and litigation claims.
Different factors may cause differences between Indivior's expectations and actual results, including: factors affecting sales of Indivior Group products; the result of research and development activities; Regulatory decisions regarding Indivior drug applications; the speed with which regulatory approvals, price approvals and product launches can be achieved; the result of post-approval clinical trials; competitive developments; difficulties or delays in manufacturing; the impact of existing and future legislation and regulations on product exclusivity; trends in care management and cost control of health; legislation or regulatory action affecting the pricing, reimbursement or access of pharmaceutical products; claims and concerns that may arise regarding the safety or effectiveness of Indivior products and product candidates; risks related to court proceedings, including ongoing investigations and antitrust proceedings; the Indivior Group's ability to protect its patents and other intellectual property rights; the outcome of a patent infringement litigation relating to the Indivior Group's products, including the ongoing lawsuits against ANDA; changes to government laws and regulations; issues related to the outsourcing of certain operational functions and personnel to third parties; uncertainties related to economic, political, commercial, industrial, regulatory and market conditions in general; and the impact of acquisitions, divestitures, restructurings, internal reorganizations, recalls and withdrawals of products and other unusual items.
This press release does not constitute an offer to sell or a solicitation of an offer to subscribe, purchase or transfer Shares of the Company to any person in a jurisdiction to which it is illegal to make such an offer or solicitation.
SUBLOCADE and RECOVER are trademarks of Indivior UK Limited.
© Indivior PLC | INDIVIOR is a registered trademark of Indivior UK Limited | All rights reserved
References
1 Responses to the treatment of Romero-Gonzalez, M., Shahanaghi, DiGirolamo, Gonzalez, buprenorphine-naloxone differ in young adults with heroin and opioid use disorders. # 39; s prescription. Follow J Addict. 2017 26 (8): 838-844.
2 Hillhouse M, Canamar CP, Doraimani G, Thomas C, Hbadon A, Ling W. Characteristics of participant and dose of buprenorphine. Am J Addiction. 2011; 33 (5): 453-459.
3 Drug Enforcement Administration of the United States. Fentanyl fact sheet. (2017). Excerpt from: https://www.dea.gov/factsheets/fentanyl. Accessed March 26, 2019.
4 National Institute for Combating Drug Abuse. Overdose mortality rate. (2019). From: https://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates. Accessed March 26, 2019.
5 Nbader AF, Greenwald MK, Vince B, et al. Buprenorphine sustained release (RBP-6000) blocks the effects of opioid challenge with hydromorphone in subjects with opioid use disorder. J Clin Psychopharmacol. 2016 36 (1): 18-26.
6 Haight B, S learned, C de Laffont, P of Fudala, Y of Zhao, A of Garofalo, Mr. Greenwald, V of Nadipelli, W Ling, Heidbreder C. (2019). Efficacy and safety of a monthly injection of buprenorphine deposit in the treatment of opioid consumption disorders: randomized, double-blind placebo-controlled multicenter trial. Lancet. DOI: http://dx.doi.org/10.1016/S0140-6736(18)32259-1. [Epub ahead of print ]7 SUBLOCADE™ [Prescribing Information]. Indivior Inc., North Chesterfield, VA. March 2018
8 American Association of Psychiatry. (2013). Diagnostic and Statistical Manual of Mental Disorders (5th ed.). Arlington, VA: American Psychiatric Publishing.
9 Administration of Addiction and Mental Health Services. (2017). Key indicators of substance use and mental health in United States: Results from the 2016 National Survey on Drug Use and Health (HHS Publication No. SMA 17-5044, NSDUH Series H-52). Rockville, MD: Center for Behavioral Health Statistics and Administration of Quality Services, Addiction and Mental Health. Retrieved from: https://www.samhsa.gov/data/sites/default/files/NSDUH-FFR1-2016/NSDUH-FFR1-2016.htm. Accessed March 23, 2018.
ten Centers for Disaster Control and Prevention. (2017). Data on prescription overdose of opioids. Retrieved from: https://www.cdc.gov/drugoverdose/data/overdose.html. Accessed March 23, 2018.
11 Centers for Disaster Control and Prevention. Understand the epidemic. From: https://www.cdc.gov/drugoverdose/epidemic/index.html. Accessed March 23, 2018.
12 GBD 2016 collaborators on alcohol and drug consumption. (2018). World Burden of Morbidity from Alcohol and Drug Use in 195 Countries and Territories, 1990-2016: A Systematic Analysis for the 2016 Global Burden of Disease Study. Lancet Psychiatry. DOI: https://doi.org/10.1016/S2215-0366(18)30337-7.
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