- |||||||||| Sublocade (buprenorphine once-monthly depot) / Indivior
Enrollment change, Trial completion date, Trial withdrawal, Trial primary completion date: Buprenorphine vs Buprenorphine/Naloxone on the Effects of Maternal Symptomatology (clinicaltrials.gov) - Mar 24, 2020
P4, N=0, Withdrawn,
Product-specific rates of emergency department visits for unintentional ingestions can help prioritize preventive interventions, such as enhancing safety packaging with flow restrictors. N=144 --> 0 | Trial completion date: Sep 2020 --> Mar 2020 | Recruiting --> Withdrawn | Trial primary completion date: Jun 2020 --> Mar 2020
- |||||||||| Zubsolv (buprenorphine/naloxone sublingual tablet) / Orexo, Mundipharma, Suboxone (buprenorphine/naloxone sublingual film) / Indivior
Clinical, Journal: Perioperative opioid requirements of patients receiving sublingual buprenorphine-naloxone: a case series. (Pubmed Central) - Feb 22, 2020
Regardless of the type of anesthesia used, physicians treating patients with SL-BUP must be prepared to administer large doses of opioids during the early postoperative period. No difference in opioid requirements was noted between patients who perioperatively stopped SL-BUP versus those who continued SL-BUP.
- |||||||||| Copegus (ribavirin) / Bausch Health, Zubsolv (buprenorphine/naloxone sublingual tablet) / Orexo, Mundipharma, sofosbuvir+velpatasvir / Generic mfg.
Successful Treatment of Hepatitis C by Psychiatrists at an Outpatient Addiction Clinic () - Feb 20, 2020 - Abstract #ASAM2020ASAM_215;
Three subjects had prior unsuccessful HCV treatment with interferon/ribavirin... Our pilot study suggests that uncomplicated HCV infection may be effectively treated by psychiatrists at regularly scheduled visits for buprenorphine/naloxone prescribing and mental health care.
- |||||||||| Zubsolv (buprenorphine/naloxone sublingual tablet) / Orexo, Mundipharma, Suboxone (buprenorphine/naloxone sublingual film) / Indivior
Buprenorphine XR in Jail and at Re-Entry vs. Daily Sublingual Buprenorphine-Naloxone: Pilot () - Feb 20, 2020 - Abstract #ASAM2020ASAM_172;
The opioid and overdose epidemic has intensified efforts to expand and optimize effective medicated assisted treatments (methadone, extended-release naltrexone, buprenorphine) in criminal justice and primary care populations... The new buprenorphine extended-release formulation (XR-B) has several potential feasibility and effectiveness advantages vs. daily sublingual buprenorphine (SL-B), including: 1) fewer overall medical, nursing, and pharmacy visits, fewer correctional staff hours, and potentially lower program costs vs. daily observed dosing, 2) near zero probability of diversion/misuse vs.
- |||||||||| ibuprofen / Generic mfg.
Clinical, PK/PD data, Review, Journal: Opioids: A Review of Pharmacokinetics and Pharmacodynamics in Neonates, Infants, and Children. (Pubmed Central) - Feb 7, 2020
Mild pain is usually managed quite well with oral acetaminophen or ibuprofen...This review provides pharmacokinetic and pharmacodynamic evidence on the currently available opioids: morphine, fentanyl (and derivatives), codeine, meperidine, oxycodone, hydrocodone, hydromorphone, methadone, buprenorphine, butorphanol, nalbuphine, pentazocin, ketobemidone, tramadol, piritramide, naloxone and naltrexone...Outside the premature and neonatal population, the use of opioids in infants, children, and adolescents quickly begins to resemble the established values found in adults. As such, the concerns (risks) of these medications become comparable to those seen in adults.
- |||||||||| Sublocade (buprenorphine once-monthly depot) / Indivior
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: SUBLOCADE Rapid Initiation Study (clinicaltrials.gov) - Jan 22, 2020
P4, N=49, Completed,
The present data suggest that buprenorphine/naloxone pharmacokinetic profiles in Chinese participants are consistent, overall, with those in Western populations, supporting no differences in dosing. Recruiting --> Completed | N=15 --> 49 | Trial completion date: May 2020 --> Dec 2019 | Trial primary completion date: Mar 2020 --> Dec 2019
- |||||||||| Zubsolv (buprenorphine/naloxone sublingual tablet) / Orexo, Mundipharma, Suboxone (buprenorphine/naloxone sublingual film) / Indivior
Clinical, Journal: Analgesic Effects of Hydromorphone versus Buprenorphine in Buprenorphine-maintained Individuals. (Pubmed Central) - Oct 25, 2019
In this acute clinical pain model, high doses of IV hydromorphone (16 to 32 mg) were most effective in achieving analgesia but also displayed higher abuse liability and more frequent adverse events. Cold pressor testing was the most consistent measure of opioid-related analgesia.
- |||||||||| Zubsolv (buprenorphine/naloxone sublingual tablet) / Orexo, Mundipharma, Vivitrol (naltrexone extended-release injectable suspension) / Alkermes, Suboxone (buprenorphine/naloxone sublingual film) / Indivior
Clinical, Journal, Interview: Effects of motivational interviewing fidelity on substance use treatment engagement in primary care. (Pubmed Central) - Oct 24, 2019
Training providers to strategically use MI to reinforce change as opposed to the status quo is needed. This may be especially important in primary care where patients may not be specifically seeking help for their OAUDs.
- |||||||||| Zubsolv (buprenorphine/naloxone sublingual tablet) / Orexo, Mundipharma, Suboxone (buprenorphine/naloxone sublingual film) / Indivior
Trends and Characteristics of Buprenorphine Sublingual Tablet Toxicities. (SOUTH HALL 3C) - Oct 20, 2019 - Abstract #EUSEM2019EUSEM_1971;
Considering the discontinuation of the sublingual tablets, it is imperative to explore in greater detail, the reasons for the observed exposures. Possible reasons for these observed exposures might be the continued availability despite discontinuation or potential diversion of the product
- |||||||||| Zubsolv (buprenorphine/naloxone sublingual tablet) / Orexo, Mundipharma, Suboxone (buprenorphine/naloxone sublingual film) / Indivior
Clinical, Journal: Injectable naltrexone, oral naltrexone, and buprenorphine utilization and discontinuation among individuals treated for opioid use disorder in a United States commercially insured population. (Pubmed Central) - Oct 18, 2019
In the Cox proportional hazard model, use of injectable naltrexone, oral naltrexone, sublingual buprenorphine, and transdermal buprenorphine were all associated with significantly greater hazard of discontinuing therapy beginning >30days after MOUD initiation (HR=2.17, 2.54, 1.15, and 2.21, respectively, 95% CIs 2.04-2.30, 2.45-2.64, 1.10-1.19, and 2.11-2.33), compared with the use of sublingual or oralmucosal buprenorphine/naloxone...The proportion treated with injectable naltrexone, oral naltrexone, and transdermal buprenorphine grew over time but remains small, and the discontinuation rates are higher among those treated with these medications compared with those treated with sublingual or oralmucosal buprenorphine/naloxone. In the face of the opioid overdose and addiction crisis, new efforts are needed at the provider, health system, and policy levels so that MOUD availability and uptake keep pace with new OUD diagnoses and OUD treatment discontinuation is minimized.
- |||||||||| Zubsolv (buprenorphine/naloxone sublingual tablet) / Orexo, Mundipharma, Suboxone (buprenorphine/naloxone sublingual film) / Indivior
Journal: Buprenorphine/Naloxone (Zubsolv): A Review in Opioid Dependence. (Pubmed Central) - Oct 13, 2019
Buprenorphine/naloxone was generally well tolerated, displaying a tolerability profile that was generally consistent with that seen with reference buprenorphine/naloxone. In conclusion, with potentially greater patient preference and a lower potential for parenteral buprenorphine abuse than reference buprenorphine/naloxone, buprenorphine/naloxone expands the treatment options available for adults and adolescent (aged > 15 years) patients with opioid dependence.
- |||||||||| Sublocade (buprenorphine once-monthly depot) / Indivior
Enrollment open: SUBLOCADE Rapid Initiation Study (clinicaltrials.gov) - Sep 9, 2019
P4, N=15, Recruiting,
In conclusion, with potentially greater patient preference and a lower potential for parenteral buprenorphine abuse than reference buprenorphine/naloxone, buprenorphine/naloxone expands the treatment options available for adults and adolescent (aged > 15 years) patients with opioid dependence. Not yet recruiting --> Recruiting
- |||||||||| Zubsolv (buprenorphine/naloxone sublingual tablet) / Orexo, Mundipharma, Suboxone (buprenorphine/naloxone sublingual film) / Indivior
Clinical, Review, Journal: Treatment of Chronic Pain With Various Buprenorphine Formulations: A Systematic Review of Clinical Studies. (Pubmed Central) - Aug 17, 2019
No serious adverse effects were reported in any of the studies. We conclude that a transdermal buprenorphine formulation is an effective analgesic in patients with chronic pain, while buccal buprenorphine is also a promising formulation based on the limited number of studies.
- |||||||||| Zubsolv (buprenorphine/naloxone sublingual tablet) / Orexo, Mundipharma, buprenorphine/naloxone sublingual tablet / Aoxing, Suboxone (buprenorphine/naloxone sublingual film) / Indivior
Journal: Comparison of Buprenorphine and Buprenorphine/naloxone in Detoxification of Opioid-dependent Men. (Pubmed Central) - Jul 3, 2019
Buprenorphine sublingual tablets are now available in Iran for opioid detoxification in clinics...Moreover, there was no significant difference between the two groups in terms of objective and subjective symptom reduction (P > 0.050). Buprenorphine/naloxone is as effective as buprenorphine in controlling opiate withdrawal symptoms.
- |||||||||| Sublocade (buprenorphine once-monthly depot) / Indivior
New P4 trial: SUBLOCADE Rapid Initiation Study (clinicaltrials.gov) - Jun 19, 2019
P4, N=15, Not yet recruiting,
- |||||||||| Zubsolv (buprenorphine/naloxone sublingual tablet) / Orexo, Mundipharma
Trial completion date, Trial primary completion date: Assessing the Safety of Buprenorphine in People With Sickle Cell Disease (clinicaltrials.gov) - Jun 12, 2019
P2, N=20, Enrolling by invitation,
Trial completion date: Dec 2020 --> Jun 2020 | Trial primary completion date: Dec 2020 --> Apr 2020 Trial completion date: Jan 2020 --> Jun 2020 | Trial primary completion date: May 2019 --> Jun 2020
- |||||||||| Zubsolv (buprenorphine/naloxone sublingual tablet) / Orexo, Mundipharma, Bunavail (buprenorphine/naloxone transmucosal) / BDSI
Clinical, Reimbursement, Journal, Medicaid: Decline in Buprenorphine/Naloxone Prescriptions in a State Medicaid Population Following Formulary Conversion from Suboxone to Bunavail. (Pubmed Central) - May 31, 2019
The changing market dynamics can potentially be explained by a number of contributory factors, including a reduction of diversion and illicit distribution of BN following formulary conversion. These results are considered hypothesis-generating and future research should systematically compare the propensity for diversion and abuse of BN products using various epidemiological tracking tools.
- |||||||||| Zubsolv (buprenorphine/naloxone sublingual tablet) / Orexo, Mundipharma
Journal: Single high-dose buprenorphine for opioid craving during withdrawal. (Pubmed Central) - May 22, 2019
These results are considered hypothesis-generating and future research should systematically compare the propensity for diversion and abuse of BN products using various epidemiological tracking tools. A single, high dose of buprenorphine can reduce craving during opioid withdrawal; additional studies with follow-up are warranted to evaluate safety.
- |||||||||| Zubsolv (buprenorphine/naloxone sublingual tablet) / Orexo, Mundipharma, Sublocade (buprenorphine once-monthly depot) / Indivior
Clinical, P3 data, Clinical Trial,Phase I, Clinical Trial,Phase II, Clinical Trial,Phase III, Journal: Efficacy and safety of a monthly buprenorphine depot injection for opioid use disorder: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. (Pubmed Central) - Apr 19, 2019
P3
Treatment with BUP-XR was also well tolerated. The availability of this monthly formulation, delivered by health-care providers, represents an advance in treatment for opioid use disorder that enhances the benefits of buprenorphine by delivering sustained, optimal exposure, while reducing risks of current buprenorphine products.
- |||||||||| Sublocade (buprenorphine once-monthly depot) / Indivior
Trial initiation date: XRB vs. SLB in Jail and at Re-entry: Pilot, Proof of Concept (clinicaltrials.gov) - Apr 8, 2019
P4, N=50, Not yet recruiting,
ISRCTN41645723 is retrospectively registered on 15/11/2015. Initiation date: Aug 2018 --> May 2019
- |||||||||| Zubsolv (buprenorphine/naloxone sublingual tablet) / Orexo, Mundipharma
Enrollment closed, Adherence: Multi-Center, Open-Label, 24-Week Study of OX219 Safety and Efficacy for Maintenance Treatment of Opioid Dependence (clinicaltrials.gov) - May 5, 2014
P4, N=700, Active, not recruiting,
Trial completion date: Mar 2014 --> Apr 2014 Recruiting --> Active, not recruiting
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