Zubsolv (buprenorphine/naloxone sublingual tablet) / Orexo, Mundipharma - LARVOL DELTA

ED-ENVISION: Standard Versus High Dose ED-Initiated Buprenorphine Induction (clinicaltrials.gov) - P3 | N=360 | Recruiting | Sponsor: Yale University | Not yet recruiting ➔ Recruiting

Enrollment open • Substance Abuse

ED-ENVISION: Standard Versus High Dose ED-Initiated Buprenorphine Induction (clinicaltrials.gov) - P3 | N=360 | Not yet recruiting | Sponsor: Yale University | Initiation date: Aug 2024 ➔ Nov 2024

Trial initiation date • Substance Abuse

ED-ENVISION: Standard Versus High Dose ED-Initiated Buprenorphine Induction (clinicaltrials.gov) - P3 | N=360 | Not yet recruiting | Sponsor: Yale University

New P3 trial • Substance Abuse

Depression Scores Modulate the Relationship Between Stress-Reactivity and Opioid Demand (CPDD 2024) - ": This study used a 4-period medication dose (ER-morphine and 3 buprenorphine/naloxone [B/N] doses) X pharmacological stress ([yohimbine 60mg + hydrocortisone 40mg] vs. placebo) within-subject, crossover design...Next, each participant completed 3 medication phases; each involved stabilization for 2 weeks outpatient on low, moderate or high B/N doses (1.4/0.36, 4.2/1.08, and 12.8/3.2 mg/day [counterbalanced] Zubsolv™ sublingual tablets)... Depression scores moderate the relationship between stress-reactivity and opioid demand. Stress plays a significant role in relapse, so these findings have implications for interoceptive theory and intervention development. Inter-individual differences in responsivity (which could be measured in ambulatory settings) might predict variation in stress-induced opioid use and aid in targeting interventions."

Addiction (Opioid and Alcohol) • CNS Disorders • Depression • Mood Disorders • Pain • Psychiatry • Substance Abuse

Drugs for opioid use disorder. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Addiction (Opioid and Alcohol) • CNS Disorders • Substance Abuse

Comparison table: Some drugs for maintenance treatment of opioid use disorder. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Addiction (Opioid and Alcohol) • Substance Abuse

Buprenorphine and its formulations: a comprehensive review. (PubMed, Health Psychol Res) - "For the purpose of analgesia, three formulations of buprenorphine were developed: IV/IM injectable formulation (Buprenex®), transdermal patch formulation (Butrans®), and buccal film formulation (Belbuca®). Related to opioid dependence, the formulations developed were subcutaneous extended release (Sublocade®), subdermal implant (Probuphine®), and sublingual tablets (Subutex®). Lastly, in order to avoid misuse of buprenorphine for opioid dependence, two combination formulations paired with naloxone were developed: film formulation (Suboxone®) and tablet formulation (Zubsolv®). In this review, we present details of each formulation along with their similarities and differences between each other and clinical considerations."

Journal • Review • Addiction (Opioid and Alcohol) • Pain • Substance Abuse

COMBO: Efficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder (clinicaltrials.gov) - P2/3 | N=180 | Recruiting | Sponsor: New York State Psychiatric Institute | Not yet recruiting ➔ Recruiting

Enrollment open • Substance Abuse

COMBO: Efficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder (clinicaltrials.gov) - P2/3 | N=180 | Not yet recruiting | Sponsor: New York State Psychiatric Institute | Initiation date: May 2022 ➔ Aug 2022

Trial initiation date • Substance Abuse

Mu-Opioid Receptor Epigenetics in Persons With Opioid Use Disorder: A Pilot Study (CPDD 2022) - "Nine of these participants completed a within-subject crossover study, starting with 2 days of oral morphine stabilization (tailored to pre-experimental opioid use; range, 30 ¢â‚¬â€œ75 mg TID), followed by randomized, blinded exposure for 2 weeks each to low, moderate, and high daily doses of sublingual B/N (1.4/0.36, 4.2/1.08, and 12.8/3.2 mg Zubsolv ¢â€žÂ¢) and provided epigenetic and symptom data in each medication condition. Although sample size is small, these preliminary data suggest µ-receptor DNA methylation appears related to age (senescence clock), current heroin use, and parental divorce/separation (but not other early-life stressors), whereas short-term stabilization on different doses of B/N does not affect µ-receptor methylation."

Clinical • Addiction (Opioid and Alcohol) • CNS Disorders • Pain • Psychiatry • Substance Abuse

Characterization of Buprenorphine Antagonism at Human Mu Opioid Receptors. (PubMed, FASEB J) - "One such medication is buprenorphine, an FDA approved drug for the treatment of opioid use disorder sold under the brand Suboxone®, Subutex®, and Zubsolv®...Similar antagonism by buprenorphine was observed when fentanyl was used as the MOR agonist...These kinetics were further supported in high-expressing hMOR CHO cells, as buprenorphine agonism was resistant to reversal by naloxone or washing. As a frontline treatment for opioid use disorder, an understanding of buprenorphine's pseudo-irreversible binding may elucidate buprenorphine's unique properties and facilitate future drug discovery."

Journal • Addiction (Opioid and Alcohol) • CNS Disorders • Substance Abuse

Assessing the Safety of Buprenorphine in People With Sickle Cell Disease (clinicaltrials.gov) - P2 | N=47 | Completed | Sponsor: Johns Hopkins University | Active, not recruiting ➔ Completed

Trial completion • Genetic Disorders • Hematological Disorders • Sickle Cell Disease

"Suboxone, subutex, zubsolv, sublocade, for sure. Methadone inferior. Naloxone inferior. Naltrexone - Vivitrol, for sure." (@EdoajoEric)

Assessing the Safety of Buprenorphine in People With Sickle Cell Disease (clinicaltrials.gov) - P2; N=47; Active, not recruiting; Sponsor: Johns Hopkins University; Trial completion date: Jun 2021 ➔ Dec 2021

Clinical • Trial completion date • Genetic Disorders • Hematological Disorders • Sickle Cell Disease

"Orexo continues to strengthen ZUBSOLV´s patent portfolio with two new patents https://t.co/HpuSfIMI91" (@CisionNews)

Dosage Details for Zubsolv - "If you begin to have signs and symptoms of withdrawal, your doctor will likely recommend additional doses of Zubsolv on the first day of treatment. Remember that dosing differs for each person. Once your doctor has found the right dose of Zubsolv for you, you will continue on a once-daily dose of Zubsolv for maintenance treatment. Melissa Badowski, PharmD, MPH, FCCPAnswers represent the opinions of our medical experts."

"Orexo continues to strengthen IP rights for ZUBSOLV® https://t.co/rO2rSUDEZj" (@CisionNews)

XRB vs. SLB in Jail and at Re-entry: Pilot, Proof of Concept (clinicaltrials.gov) - P4; N=52; Completed; Sponsor: NYU Langone Health; Recruiting ➔ Completed; Trial completion date: Sep 2020 ➔ May 2020

Clinical • Trial completion • Trial completion date • Addiction (Opioid and Alcohol)

Pharmacokinetic Characterization and External Evaluation of a Quantitative Framework of Sublingual Buprenorphine in Patients with an Opioid Disorder in Puerto Rico. (PubMed, Pharmaceutics) - "Although limited in sampling time and number of recruited subjects, this study presents specific BUP PK characteristics that evidenced the need for additional PK studies and subsequent modeling of the data for the development of evidence-based dosing approaches in Puerto Rico."

Clinical • Journal • PK/PD data • Addiction (Opioid and Alcohol)

[VIRTUAL] Assessment of Opioid Withdrawal with Clinical Opiate Withdrawal Scale Treatment Protocol at A Community Psychiatric Hospital (ASHP 2020) - "Buprenorphine sublingual tablet was the primary choice of medication for the COWS protocol used, with 98 (84%) of patients receiving a dose correlating to their respective COWS scores. For the remainder patients, methadone was administered to 6 (5%), buprenorphine-naloxone sublingual tablets to 2 (2%), a combination regimen of buprenorphine and buprenorphine-naloxone to 1 (1%), and no medication to 10 (8%)... The Clinical Opiate Withdrawal Scale serves as a useful tool in assessing patients with opioid use disorder withdrawal. In the interim analysis, only a small percentage of patients were assessed with the COWS protocol at the frequency as indicated by the opioid withdrawal order set. This demonstrates the need to re-evaluate optimal dosing strategies in opioid use disorder patients or education on the use of the COWS protocol."

Clinical • Psychiatry

[VIRTUAL] Opioid-Use Related Adverse Drug Effects in Surgical Patients on Long-Acting Opioids Prior to Admission (ASHP 2020) - "The exclusion criteria were opioid naïve patients (no opioid at PTA), patients with active cancer tumor diagnosis, opioid dependence diagnosis at admission, on Suboxone (buprenorphine/naloxone) or methadone PTA, discharged to any facility other than home, patients with incapacitating disease (ASA score 4 or higher), moribund, or brain dead... Concomitant use of long-acting and short-acting opioids prior to hospital admission for an elective surgical procedure, female gender, and hospital length of stay were the strongest predictors of increased risk of developing PONV and pruritus. Future work can look into pharmacist-led services for opioid management through preoperative interventions in determining the opiate need for patients at hospital admission, in particular with patients on multiple opioid formulations, for further reduction of adverse events in their continuum of care."

Clinical • Addiction (Opioid and Alcohol) • Anesthesia • Dermatology • Oncology • Pain • Pruritus

An alternative analysis of illicit opioid use during treatment in a randomized trial of extended-release naltrexone versus buprenorphine-naloxone: A per-protocol and completers analysis. (PubMed, Drug Alcohol Depend) - "Longitudinal modeling approaches that utilize flexible procedures for handling missing data can offer a different perspective on study findings. Results from the present analyses suggest that XR-NTX appeared to be somewhat more effective than BUP-NX in reducing illicit opioid use in the per-protocol sample."

Clinical • Journal

"Orexo announces new US patent for ZUBSOLV® https://t.co/4GTq59LPoV" (@CisionNews)

[VIRTUAL] Assessment of opioid use following implementation of multimodal pain management in hospitalized trauma patients (ASHP 2020) - "Patients were excluded if their hospital stay was less than 5 days, a history of opioid use disorder (OUD) was documented, or pre-admission medications included methadone or buprenorphine. The primary endpoint was to compare the cumulative OME doses over the second through fifth days of admission and prior to discharge for both groups. Secondary endpoints included discharge prescription OME dose and naloxone use."

Clinical • Addiction (Opioid and Alcohol) • CNS Disorders • Mood Disorders • Pain • Psychiatry

[VIRTUAL] Development and implementation of a naloxone co-dispensing protocol for patients receiving orthopedic surgery (ASHP 2020) - " Patients who receive either a total hip or knee arthroplasty at LMH Health during the study period will be screened for OIRD using the following criteria: currently taking benzodiazepines or other medicines that depress the central nervous system, history of opioid use disorder (OUD), previous opioid overdose, presence of household members at risk for accidental opioid ingestion or overdose, prescribed oral morphine equivalents (OME) greater than 50 mg/day and/or long-acting opioid, and current prescription for buprenorphine or methadone to treat OUD...Primary endpoints include rate of naloxone recommendation after screening and patient acceptance of naloxone after counseling. Secondary outcomes could include patient cost, OME prescribed on discharge, and risk factors identified in this patient population."

Clinical • Addiction (Opioid and Alcohol) • CNS Disorders • Depression • Orthopedics • Psychiatry