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- | Sublocade (buprenorphine once-monthly depot) / Indivior
Review, Journal: New slow-release buprenorphine formulations for optimization of opioid substitution (Pubmed Central) - Sep 27, 2019
In addition to the novel weekly and monthly subcutaneously injectable buprenorphine depot CAM 2038 (Buvidal®), which is already available in Germany, two other long-acting buprenorphine formulations may be introduced in the near future: the monthly depot formulation RBP-6000 (Sublocade™) and a 6-month buprenorphine depot implant (Probuphine™). Basic pharmacological and clinical data of these three medications are given and possible clinical applications are discussed.
- | Sublocade (buprenorphine once-monthly depot) / Indivior
Enrollment open: SUBLOCADE Rapid Initiation Study (clinicaltrials.gov) - Sep 9, 2019
P4, N=15, Recruiting, Sponsor: Indivior Inc.
Basic pharmacological and clinical data of these three medications are given and possible clinical applications are discussed. Not yet recruiting --> Recruiting
- | Perseris (risperidone sustained-release 1-month depot) / Indivior, Reckitt Benckiser, HLS Therap, Sublocade (buprenorphine once-monthly depot) / Indivior
well, on a "higher tech" side, I guess you have to go back to Sublocade or Perseris ph3... (Twitter) - Aug 29, 2019
- | Sublocade (buprenorphine once-monthly depot) / Indivior
New P4 trial: SUBLOCADE Rapid Initiation Extension Study (clinicaltrials.gov) - Aug 19, 2019
P4, N=15, Not yet recruiting, Sponsor: Indivior Inc.
- | Sublocade (buprenorphine once-monthly depot) / Indivior
Trial completion, Trial completion date: Evaluation of Long-term Buprenorphine Plasma Exposure (clinicaltrials.gov) - Jul 24, 2019
P3, N=53, Completed, Sponsor: Indivior Inc.
Not yet recruiting --> Recruiting Enrolling by invitation --> Completed | Trial completion date: Dec 2019 --> Jul 2019
- | Sublocade (buprenorphine once-monthly depot) / Indivior
New P4 trial: SUBLOCADE Rapid Initiation Study (clinicaltrials.gov) - Jun 19, 2019
P4, N=15, Not yet recruiting, Sponsor: Indivior Inc.
- || Sublocade (buprenorphine once-monthly depot) / Indivior
Adolescents have highest drop out rates from pharmacotherapy for OUD, especially in first 3-12mos of Treatment, the same window with the highest risk of OD deaths (for all age groups). What does this tell us? #sublocade for adolescents? ↗️dose of strips? We can do better. (Twitter) - Jun 8, 2019
- | Sublocade (buprenorphine once-monthly depot) / Indivior
Enrollment open: Community Studies of Long Acting Buprenorphine (CoLAB) (clinicaltrials.gov) - May 28, 2019
P3, N=100, Recruiting, Sponsor: The University of New South Wales
Enrolling by invitation --> Completed | Trial completion date: Dec 2019 --> Jul 2019 Not yet recruiting --> Recruiting
- |||| Sublocade (buprenorphine once-monthly depot) / Indivior
Clinical: Is your study part of the NIDA clinical trials network or separate? I’d be happy to chat about the qualitative piece here or offline—I think that patient acceptability of sublocade/brixadi is going to be key and is heretofore unknown. (Twitter) - May 17, 2019
- |||| Sublocade (buprenorphine once-monthly depot) / Indivior
Orphan drug: The fascinating world of OUD XR drug therapies...Why would @US_FDA consider Orphan Drug exclusivity for @Indivior’s Sublocade? (this is exactly what Suboxone originally received in 2002-2003). Winner take all incentives for single product lanes? Importantly Brixadi has weekly. (Twitter) - Apr 23, 2019
- | 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 completion date: Community Studies of Long Acting Buprenorphine (CoLAB) (clinicaltrials.gov) - Apr 19, 2019
P3, N=100, Not yet recruiting, Sponsor: The University of New South Wales
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. Trial completion date: Jun 2021 --> Mar 2021
- | Sublocade (buprenorphine once-monthly depot) / Indivior
Drugmaker Petitions FDA to Revoke Sublocade Orphan Designation #Drugmaker #FDA #Revoke #Sublocade #Orphan #Designation @RAPSorg https://t.co/P1Hx45qRsA (Twitter) - Apr 16, 2019
- | Sublocade (buprenorphine once-monthly depot) / Indivior
Braeburn petitions FDA to revoke Sublocade orphan designation by @michael_mezher Mezher via @RAPSorg https://t.co/hqZBsUdZaI (Twitter) - Apr 11, 2019
- || Sublocade (buprenorphine once-monthly depot) / Indivior
And now there doing the same for sublocade shot and the indictment against them actually works in there favor of FDA grants exclusivity for Sublocade boxing out Braeburn’s Brixadi Bupe depot product. (Twitter) - Apr 10, 2019
- ||| Sublocade (buprenorphine once-monthly depot) / Indivior
This citation is really not good to use because it’s supported by Indivior, that is, funded by Indivior. They want to show diversion is both a problem and not a problem. A problem: because it supports migration to sublocade shot. Not a problem: cuz it supports branded Suboxone. (Twitter) - Apr 8, 2019
- | Sublocade (buprenorphine once-monthly depot) / Indivior
@ASAMorg @IndiviorPlc @CDCgov #sublocade gaining momentum, net effect of new $1500+/mo shot? https://t.co/D6Q2ILwBpm (Twitter) - Apr 8, 2019
- | 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, Sponsor: New York University School of Medicine
Trial completion date: Jun 2021 --> Mar 2021 Initiation date: Aug 2018 --> May 2019
- ||| Sublocade (buprenorphine once-monthly depot) / Indivior
Clinical: Depends if intent is maint. or trans to sublocade or protocol to abstinence from a brief use recurrence? Typ. don’t start >12 mg on day 1 unless inpt, but happy to go to 16 d2 and 24 d3 if indicated. I try for 8-12/d for sublocade, </=16 if tapering. Individualized above all. (Twitter) - Apr 4, 2019
- | Sublocade (buprenorphine once-monthly depot) / Indivior
New P1/2 trial: An Open-Label Pilot Study of Sublocade as Treatment for Opiate Use Disorder (clinicaltrials.gov) - Mar 4, 2019
P1/2, N=10, Recruiting, Sponsor: New York State Psychiatric Institute
- |||| Sublocade (buprenorphine once-monthly depot) / Indivior
Enrollment open: Evaluation of Long-term Buprenorphine Plasma Exposure (clinicaltrials.gov) - Feb 22, 2019
P3, N=60, Enrolling by invitation, Sponsor: Indivior Inc.
Initiation date: Aug 2018 --> May 2019 Not yet recruiting --> Enrolling by invitation
- |||||||| Sublocade (buprenorphine once-monthly depot) / Indivior
New P3 trial: VOTIVE: Virginia Opioid Overdose Treatment InitiatVE (clinicaltrials.gov) - Jan 28, 2019
P3, N=150, Recruiting, Sponsor: Virginia Commonwealth University
- | Sublocade (buprenorphine once-monthly depot) / Indivior
New P3 trial: Community Studies of Long Acting Buprenorphine (CoLAB) (clinicaltrials.gov) - Jan 18, 2019
P3, N=100, Not yet recruiting, Sponsor: The University of New South Wales
- | Sublocade (buprenorphine once-monthly depot) / Indivior
New P3 trial: Evaluation of Long-term Buprenorphine Plasma Exposure (clinicaltrials.gov) - Nov 26, 2018
P3, N=60, Not yet recruiting, Sponsor: Indivior Inc.
- | Sublocade (buprenorphine once-monthly depot) / Indivior
New P2 trial: Long Acting Buprenorphine Injection Compared to Sublingual Buprenorphine/Naloxone Films (clinicaltrials.gov) - Nov 16, 2018
P2, N=30, Not yet recruiting, Sponsor: Wake Forest University Health Sciences
- | Sublocade (buprenorphine once-monthly depot) / Indivior
New P4 trial: Buprenorphine vs Buprenorphine/Naloxone on the Effects of Maternal Symptomatology (clinicaltrials.gov) - Nov 14, 2018
P4, N=144, Recruiting, Sponsor: Stony Brook University
- | Sublocade (buprenorphine once-monthly depot) / Indivior
New P4 trial: XRB vs. SLB in Jail and at Re-entry: Pilot, Proof of Concept (clinicaltrials.gov) - Jul 26, 2018
P4, N=50, Not yet recruiting, Sponsor: New York University School of Medicine
- ||||| Sublocade (buprenorphine once-monthly depot) / Indivior
Enrollment change: Treatment Seeking Participants With Opioid Use Disorders Assessing Tolerability of Depot Injections of Buprenorphine (clinicaltrials.gov) - Feb 20, 2018
P3, N=665, Completed, Sponsor: Indivior Inc.
Not yet recruiting --> Enrolling by invitation N=505 --> 665
- || Sublocade (buprenorphine once-monthly depot) / Indivior
Trial primary completion date: Multiple Dose Pharmacokinetics Depot Buprenorphine in Opioid-Dependent Subjects (clinicaltrials.gov) - Jan 23, 2018
P2, N=124, Completed, Sponsor: Indivior Inc.
N=505 --> 665 Trial primary completion date: Sep 2013 --> May 2014
- ||||||| Sublocade (buprenorphine once-monthly depot) / Indivior
Trial completion, Enrollment change: Open-Label Treatment Extension Study (clinicaltrials.gov) - Sep 19, 2017
P3, N=208, Completed, Sponsor: Indivior Inc.
Trial primary completion date: Sep 2013 --> May 2014 Active, not recruiting --> Completed | N=600 --> 208
- ||||| Sublocade (buprenorphine once-monthly depot) / Indivior
Enrollment closed: Open-Label Treatment Extension Study (clinicaltrials.gov) - Jul 31, 2017
P3, N=600, Active, not recruiting, Sponsor: Indivior Inc.
Active, not recruiting --> Completed | N=600 --> 208 Enrolling by invitation --> Active, not recruiting
- ||||||| Sublocade (buprenorphine once-monthly depot) / Indivior
Trial completion: Safety and Tolerability Study of Depot Buprenorphine in Treatment Seeking Subjects With Opioid Use Disorder (clinicaltrials.gov) - Feb 7, 2017
P3, N=672, Completed, Sponsor: Indivior Inc.
Enrolling by invitation --> Active, not recruiting Active, not recruiting --> Completed
- | Sublocade (buprenorphine once-monthly depot) / Indivior
New P1 trial: Single Ascending Dose Study of RBP-6000 (clinicaltrials.gov) - Dec 27, 2016
P1, N=48, Completed, Sponsor: Indivior Inc.
- |||||||||| Sublocade (buprenorphine once-monthly depot) / Indivior
New P3 trial: Open-Label Treatment Extension Study (clinicaltrials.gov) - Sep 12, 2016
P3, N=600, Enrolling by invitation, Sponsor: Indivior Inc.
- ||||||| Sublocade (buprenorphine once-monthly depot) / Indivior
Trial completion: Treatment Seeking Participants With Opioid Use Disorders Assessing Tolerability of Depot Injections of Buprenorphine (clinicaltrials.gov) - Aug 25, 2016
P3, N=505, Completed, Sponsor: Indivior Inc.
Active, not recruiting --> Completed Active, not recruiting --> Completed
- ||||| Sublocade (buprenorphine once-monthly depot) / Indivior
Enrollment closed: Safety and Tolerability Study of Depot Buprenorphine in Treatment Seeking Subjects With Opioid Use Disorder (clinicaltrials.gov) - Aug 25, 2016
P3, N=672, Active, not recruiting, Sponsor: Indivior Inc.
Active, not recruiting --> Completed Enrolling by invitation --> Active, not recruiting
- Sublocade (buprenorphine once-monthly depot) / Indivior
Trial primary completion date: Treatment Seeking Participants With Opioid Use Disorders Assessing Tolerability of Depot Injections of Buprenorphine (clinicaltrials.gov) - May 13, 2016
P3, N=505, Active, not recruiting, Sponsor: Indivior Inc.
Enrolling by invitation --> Active, not recruiting Trial primary completion date: Dec 2016 --> May 2016
- Sublocade (buprenorphine once-monthly depot) / Indivior
Trial completion, Enrollment change, Trial primary completion date: Pharmacokinetics, Safety, and Tolerability of Depot Buprenorphine at Three Different Molecular Weights in Treatment-Seeking Subjects With Opioid Use Disorder (clinicaltrials.gov) - May 13, 2016
P1, N=47, Completed, Sponsor: Indivior Inc.
Trial primary completion date: Dec 2016 --> May 2016 Active, not recruiting --> Completed | N=77 --> 47 | Trial primary completion date: May 2016 --> Feb 2016
- Sublocade (buprenorphine once-monthly depot) / Indivior
Enrollment closed, Enrollment change: Pharmacokinetics, Safety, and Tolerability of Depot Buprenorphine at Three Different Molecular Weights in Treatment-Seeking Subjects With Opioid Use Disorder (clinicaltrials.gov) - May 12, 2016
P1, N=77, Active, not recruiting, Sponsor: Indivior Inc.
Active, not recruiting --> Completed | N=77 --> 47 | Trial primary completion date: May 2016 --> Feb 2016 Recruiting --> Active, not recruiting | N=48 --> 77
- Sublocade (buprenorphine once-monthly depot) / Indivior
New P1 trial: Single-dose, Study of RBP-6000 in Opioid Dependent Individuals (clinicaltrials.gov) - May 9, 2016
P1, N=18, Completed, Sponsor: Indivior Inc.
- Sublocade (buprenorphine once-monthly depot) / Indivior
Enrollment status: Safety and Tolerability Study of Depot Buprenorphine in Treatment Seeking Subjects With Opioid Use Disorder (clinicaltrials.gov) - Feb 21, 2016
P3, N=600, Enrolling by invitation, Sponsor: Indivior Inc.
Recruiting --> Active, not recruiting | N=48 --> 77 Recruiting --> Enrolling by invitation
- ||||| Sublocade (buprenorphine once-monthly depot) / Indivior
Enrollment closed: Treatment Seeking Participants With Opioid Use Disorders Assessing Tolerability of Depot Injections of Buprenorphine (clinicaltrials.gov) - Oct 19, 2015
P3, N=470, Active, not recruiting, Sponsor: Reckitt Benckiser Pharmaceuticals Inc.
Recruiting --> Enrolling by invitation Recruiting --> Active, not recruiting
- | Sublocade (buprenorphine once-monthly depot) / Indivior
New P1 trial: Pharmacokinetics, Safety, and Tolerability of Depot Buprenorphine at Three Different Molecular Weights in Treatment-Seeking Subjects With Opioid Use Disorder (clinicaltrials.gov) - Sep 25, 2015
P1, N=48, Recruiting, Sponsor: Reckitt Benckiser Pharmaceuticals Inc.
- |||||| Sublocade (buprenorphine once-monthly depot) / Indivior
Enrollment open: Safety and Tolerability Study of Depot Buprenorphine in Treatment Seeking Subjects With Opioid Use Disorder (clinicaltrials.gov) - Aug 26, 2015
P3, N=600, Recruiting, Sponsor: Reckitt Benckiser Pharmaceuticals Inc.
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- | Sublocade (buprenorphine once-monthly depot) / Indivior
Enrollment change, Trial primary completion date: Multiple Dose Study of Blockade of Opioid Effects by Injections of Buprenorphine in Participants With Opioid Disorder (clinicaltrials.gov) - Aug 24, 2015
P2, N=39, Completed, Sponsor: Reckitt Benckiser Pharmaceuticals Inc.
Not yet recruiting --> Recruiting N=30 --> 39 | Trial primary completion date: Mar 2014 --> Jul 2014
- |||||||||| Sublocade (buprenorphine once-monthly depot) / Indivior
New P3 trial: Safety and Tolerability Study of Depot Buprenorphine in Treatment Seeking Subjects With Opioid Use Disorder (clinicaltrials.gov) - Jul 28, 2015
P3, N=600, Not yet recruiting, Sponsor: Reckitt Benckiser Pharmaceuticals Inc.
- |||| Sublocade (buprenorphine once-monthly depot) / Indivior
Trial completion, Enrollment change: Multiple Dose Pharmacokinetics Depot Buprenorphine in Opioid-Dependent Subjects (clinicaltrials.gov) - Jun 4, 2015
P2, N=124, Completed, Sponsor: Reckitt Benckiser Pharmaceuticals Inc.
N=30 --> 39 | Trial primary completion date: Mar 2014 --> Jul 2014 Active, not recruiting --> Completed | N=90 --> 124
- | Sublocade (buprenorphine once-monthly depot) / Indivior
Trial completion, Trial primary completion date: Multiple Dose Study of Blockade of Opioid Effects by Injections of Buprenorphine in Participants With Opioid Disorder (clinicaltrials.gov) - Feb 19, 2015
P2, N=30, Completed, Sponsor: Reckitt Benckiser Pharmaceuticals Inc.
Active, not recruiting --> Completed | N=90 --> 124 Active, not recruiting --> Completed | Trial primary completion date: Nov 2014 --> Mar 2014
- |||||||||| Sublocade (buprenorphine once-monthly depot) / Indivior
New P3 trial: Treatment Seeking Participants With Opioid Use Disorders Assessing Tolerability of Depot Injections of Buprenorphine (clinicaltrials.gov) - Feb 6, 2015
P3, N=470, Recruiting, Sponsor: Reckitt Benckiser Pharmaceuticals Inc.
- | Sublocade (buprenorphine once-monthly depot) / Indivior
Enrollment closed, Trial primary completion date: Multiple Dose Study of Blockade of Opioid Effects by Injections of Buprenorphine in Participants With Opioid Disorder (clinicaltrials.gov) - Sep 29, 2014
P2, N=30, Active, not recruiting, Sponsor: Reckitt Benckiser Pharmaceuticals Inc.
Active, not recruiting --> Completed | Trial primary completion date: Nov 2014 --> Mar 2014 Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2014 --> Nov 2014