Opioid Dependence

7
Pipeline Programs
5
Companies
9
Clinical Trials
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
3
0
0
0
2
2
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

5 companies ranked by most advanced pipeline stage

Alkermes
AlkermesDUBLIN 4, Ireland
2 programs
1
VIVITROL 380mgPhase 41 trial
ALK21-025: Vivitrol's Cost and Treatment Outcomes RegistryN/A1 trial
Active Trials
NCT01422837CompletedEst. Oct 2013
NCT01453374CompletedEst. May 2014
City Therapeutics
City TherapeuticsMA - Cambridge
1 program
1
Buprenorphine Extended ReleasePhase 41 trial
Active Trials
NCT03604159CompletedEst. May 2020
US WorldMeds
US WorldMedsKY - Louisville
4 programs
3
1
Lofexidine HClPhase 31 trial
Lofexidine HClPhase 11 trial
Lofexidine HClPhase 11 trial
Lofexidine HClPhase 11 trial
Active Trials
NCT01558934Completed6Est. Apr 2012
NCT01820442Completed30Est. Sep 2013
NCT01650649Completed27Est. Dec 2012
+1 more trials
Providence Therapeutics
1 program
1
Hydromorphone, InjectablePhase 31 trial
Active Trials
NCT01447212CompletedEst. Feb 2016
Braeburn Pharmaceuticals
Braeburn PharmaceuticalsPA - Plymouth Meeting
1 program
ActiGraph LinkN/A1 trial
Active Trials
NCT02896660Unknown15Est. Apr 2017

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
City TherapeuticsBuprenorphine Extended Release
AlkermesVIVITROL 380mg
US WorldMedsLofexidine HCl
Providence TherapeuticsHydromorphone, Injectable
US WorldMedsLofexidine HCl
US WorldMedsLofexidine HCl
US WorldMedsLofexidine HCl
Braeburn PharmaceuticalsActiGraph Link
AlkermesALK21-025: Vivitrol's Cost and Treatment Outcomes Registry

Clinical Trials (9)

Total enrollment: 681 patients across 9 trials

NCT03604159City TherapeuticsBuprenorphine Extended Release

XRB vs. SLB in Jail and at Re-entry: Pilot, Proof of Concept

Start: Jun 2019Est. completion: May 2020
Phase 4Completed
NCT01453374AlkermesVIVITROL 380mg

A Study of VIVITROL in the Prevention of Re-arrest and Re-incarceration

Start: Jan 2011Est. completion: May 2014
Phase 4Completed
NCT01863186US WorldMedsLofexidine HCl

Efficacy, Safety and Dose-Response Study Followed by Open-Label Study of Lofexidine Treatment of Opioid Withdrawal

Start: Jun 2013Est. completion: Dec 2014603 patients
Phase 3Completed
NCT01447212Providence TherapeuticsHydromorphone, Injectable

Study to Assess Longer-term Opioid Medication Effectiveness (SALOME)

Start: Dec 2011Est. completion: Feb 2016
Phase 3Completed
NCT01820442US WorldMedsLofexidine HCl

Pharmacokinetic & Pharmacodynamic Interaction of Lofexidine and Buprenorphine in Buprenorphine Maintained Patients

Start: Mar 2013Est. completion: Sep 201330 patients
Phase 1Completed
NCT01650649US WorldMedsLofexidine HCl

Main Study of Lofexidine and Methadone Pharmacodynamic Interaction in Methadone Maintained Patients

Start: Jul 2012Est. completion: Dec 201227 patients
Phase 1Completed
NCT01558934US WorldMedsLofexidine HCl

Pilot Study of Lofexidine and Methadone Pharmacodynamic Interaction in Methadone Maintained Patients

Start: Feb 2012Est. completion: Apr 20126 patients
Phase 1Completed
NCT02896660Braeburn PharmaceuticalsActiGraph Link

Probuphine Innovations for Clinical Effectiveness (PRINCE)

Start: Sep 2016Est. completion: Apr 201715 patients
N/AUnknown
NCT01422837AlkermesALK21-025: Vivitrol's Cost and Treatment Outcomes Registry

ALK21-025: Vivitrol's Cost and Treatment Outcomes Registry

Start: Aug 2011Est. completion: Oct 2013
N/ACompleted

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

2 late-stage (Phase 3) programs — potential near-term approvals
5 companies competing in this space