Indivior Announces Seven Abstracts Accepted for Presentation at the 84th Annual Scientific Meeting of the College on Problems of Drug Dependence (CPDD)

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Indivior

09 Jun, 2022, 14:29 GMT

RICHMOND, Va., June 9, 2022 /PRNewswire/ -- Indivior PLC (LON: INDV) today announced the acceptance of seven abstracts for presentation at the 84th Annual Scientific Meeting of the College on Problems of Drug Dependence (CPDD) taking place June 11-15, 2022 in Minneapolis, MN.

Data to be presented include: a modelling study to characterize buprenorphine-fentanyl interaction and its effect on respiratory depression;  pharmacokinetic simulations of transition from transmucosal buprenorphine to SUBLOCADE® (buprenorphine extended-release) injection; novel dimensions of recovery as well as the impact of pain on recovery , both based on data from the RECOVER–LT (Remission from Chronic Opioid Use-Studying Environmental and SocioEconomic Factors on Recovery – Long-Term [NCT04577144]) study; motivations for buprenorphine misuse in opioid use disorder (OUD); and an analysis of OUD symptom subtypes and treatment patterns.1-6

Lastly, clinical Phase 1 data will be presented on INDV-2000, an oral, highly potent, selective Orexin-1 receptor (OX1R) antagonist currently under investigation as a non-opioid medication for the treatment of opioid use disorder.7

"These data help us better understand OUD treatment and recovery, as well as the role of long-acting treatments," said Christian Heidbreder, Chief Scientific Officer, Indivior. "The data presented provide new insights into how patients with opioid use disorder are managing therapeutic challenges while undergoing treatment."

Details of the data presentations:


Poster Presentation Title: Modelling Buprenorphine Mitigation of Fentanyl-Induced Respiratory
Depression  
Authors: Celine Laffont, Erik Olofsen, M. Hyke Algera, Laurence Moss, Robert Dobbins, Geert Jan Groeneveld, Monique van Velzen, Marieke Niesters, Albert Dahan
Presentation Session Date/Time: June 12th, 11:30am - 1:30pm
Presenter(s): Celine Laffont, Ph.D.  

Poster Presentation Title: Transition of Patients Established on Long–Term Transmucosal Buprenorphine
Treatment to Monthly Buprenorphine Injection
Authors: Frank Gray, Bret Ryder, Celine Laffont
Presentation Session Date/Time: June 13th, 8:00am - 10:00am
Presenter(s): Celine Laffont, Ph.D.  

Poster Presentation Title: Long-Term Recovery From Opioid Use Disorder: Identification of Recovery Subgroups and Their Association With Opioid Use, Treatment, and Quality of Life

Authors: Allison Tegge, William Craft, Hwasoo Shin, Diana Keith, Liqa Athamneh, Jeff Stein, Marco Ferreira, Howard Chilcoat, Anne Le Moigne, Angela DeVeaugh-Geiss, Warren Bickel
Presentation Session Date/Time: June 13th, 8:00am – 10:00am
Presenter(s): Allison Tegge, Ph.D.  

Poster Presentation Title: Pain in Recovery From Opioid Use Disorder: The Importance of Acute and
Chronic Pain
Authors: William Craft, Allison Tegge, Anne Le Moigne, Angela DeVeaugh-Geiss, Howard Chilcoat,
Warren Bickel
Presentation Session Date/Time: June 15, 8:00am - 10:00am
Presenter(s): William Craft, B.S. 

Poster Presentation Title: Buprenorphine Misuse in Opioid Use Disorders: Subgroups, Motivations, and
Opioid Demand  
Authors: Alexandra Goslow, Allison Tegge, Roberta Freitas-Lemos, Devin Tomlinson, William Craft,
Angela DeVeaugh-Geiss, Howard Chilcoat, Warren Bickel
Presentation Session Date/Time: June 14th, 8:00am – 10:00am
Presenter(s): Roberta Freitas-Lemos, Ph.D. 

Poster Presentation Title: Opioid Use Disorder (OUD) and Treatment for Opioid Problems Among OUD
Symptom Subtypes
Authors: Emily Miller, Angela DeVeaugh-Geiss, Howard Chilcoat
Presentation Session Date/Time: June 15th, 8:00am – 10:00am
Presenter(s): Emily Miller, B.S. 

Poster Presentation Title: First in Human Trial of the Non-Opioid Selective Orexin-1 Antagonist INDV-
2000 in Healthy Volunteers
Authors: Robert Dobbins, Martin Kankam, Rana Al-Awam, Malcolm Young
Presentation Session Date/Time: June 13th, 8:00am - 10:00am
Presenter(s): Robert Dobbins, M.D. 

About SUBLOCADE®
SUBLOCADE (buprenorphine extended-release) injection, for subcutaneous use (CIII)

INDICATION
SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a transmucosal buprenorphine-containing product, followed by dose adjustment for a minimum of 7 days.

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 called 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.

Prescription use of this product is limited under the Drug Addiction Treatment Act.

CONTRAINDICATIONS
SUBLOCADE should not be administered to patients who have been shown to be hypersensitive to buprenorphine or any component of the ATRIGEL® delivery system.

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.

Opioids can cause sleep-related breathing disorders e.g., central sleep apnea (CSA), sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. Consider decreasing the opioid using best practices for opioid taper if CSA occurs.

Strongly consider prescribing naloxone at SUBLOCADE initiation or renewal because patients being treated for opioid use disorder have the potential for relapse, putting them at risk for opioid overdose. Educate patients and caregivers on how to recognize respiratory depression and how to treat with naloxone if prescribed.


Risk of Serious Injection Site Reactions: The most common injection site reactions are pain, erythema and pruritis with some involving abscess, ulceration, and necrosis. The likelihood of serious injection site reactions may increase with inadvertent intramuscular or intradermal administration.

Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome 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 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 patient is clinically stable on 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.8 OUD may affect the parts of the brain that are necessary for life-sustaining functions.8

About Indivior

Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat addiction and serious mental illnesses. 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 both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of SUD, including alcohol use disorder and cannabis use disorder. Headquartered in the United States in Richmond, VA, Indivior employs more than 900 individuals globally and its portfolio of products is available in over 40 countries worldwide. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/indivior. 

References:

  1. Laffont CM et al. (2022) Modelling buprenorphine mitigation of fentanyl-induced respiratory depression. The College on Problems of Drug Dependence (CPDD) 84th Annual Scientific Meeting, June 11-15, 2022, Minneapolis, MN.
  2. Gray et al. (2022) Transition of patients established on long–term transmucosal buprenorphine treatment to monthly buprenorphine injection. The College on Problems of Drug Dependence (CPDD) 84th Annual Scientific Meeting, June 11-15, 2022, Minneapolis, MN.
  3. Tegge A. et al. (2022) Long-term recovery from opioid use disorder: identification of recovery subgroups and their association with opioid use, treatment, and quality of life. The College on Problems of Drug Dependence (CPDD) 84th Annual Scientific Meeting, June 11-15, 2022, Minneapolis, MN.
  4. Craft W. et al. (2022) Pain in recovery from OUD: the importance of acute & chronic pain. The College on Problems of Drug Dependence (CPDD) 84th Annual Scientific Meeting, June 11-15, 2022, Minneapolis, MN.
  5. Goslow et al. (2022) Buprenorphine misuse in opioid use disorders: subgroups, motivations, and opioid demand. The College on Problems of Drug Dependence (CPDD) 84th Annual Scientific Meeting, June 11-15, 2022, Minneapolis, MN.
  6. Miller E. et al. (2022) Opioid  use disorder (OUD) and treatment for opioid problems among OUD symptom subtypes. The College on Problems of Drug Dependence (CPDD) 84th Annual Scientific Meeting, June 11-15, 2022, Minneapolis, MN.
  7. Dobbins R. et al. (2022) First in Human Trial of the Non-Opioid Selective Orexin-1 Antagonist INDV-2000 in Healthy Volunteers. The College on Problems of Drug Dependence (CPDD) 84th Annual Scientific Meeting, June 11-15, 2022, Minneapolis, MN.
  8. U.S. Department of Health and Human Services (HHS), National Institute on Drug Abuse, National Institutes of Health. Drugs, Brains, and Behavior: The Science of Addiction. HHS Publication No. (SMA) 18-5063PT5, Printed 2018.

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