Opioid Use Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2016-12-16FDA Approved: SUBOXONE — Supplemental Application (INDIVIOR INC.)
The FDA approved a supplemental application for SUBOXONE (buprenorphine/naloxone) from Indivior, enabling an update to its labeling/indicati…
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FDA approval · 2016-12-16FDA Approved: BUPRENORPHINE HCL AND NALOXONE HCL — Supplemental Application (Amneal Pharmaceuticals LLC)
The FDA approved Amneal Pharmaceuticals LLC's supplemental application for a buprenorphine HCl and naloxone HCl product (generic) under an e…
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FDA approval · 2016-12-16FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Mylan Institutional LLC)
The FDA approved a supplemental application for methadone hydrochloride submitted by Mylan Institutional LLC. The action may involve labelin…
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FDA label_change · 2016-12-16FDA Approved: ZUBSOLV — Supplemental Application (Orexo US, Inc.)
The FDA approved a supplemental application for ZUBSOLV (buprenorphine hydrochloride and naloxone hydrochloride) by Orexo US, Inc., resultin…
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FDA approval · 2016-12-16FDA Approved: BUPRENORPHINE HYDROCHLORIDE — Supplemental Application (Advagen Pharma Ltd)
FDA approved a supplemental application for buprenorphine hydrochloride from Advagen Pharma Ltd, representing an approved amendment to an ex…
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FDA approval · 2016-12-16FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for Actavis Pharma to manufacture and distribute a generic buprenorphine and naloxone product for op…
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FDA approval · 2016-12-16FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)
FDA approved a supplemental application for a generic buprenorphine and naloxone product (PAI Holdings/PAI Pharma).
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FDA approval · 2016-12-16FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for Hikma Pharmaceuticals' buprenorphine hydrochloride and naloxone hydrochloride dihydrate, exp…
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FDA approval · 2016-12-15FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for methadone hydrochloride by Hikma Pharmaceuticals USA Inc., granting regulatory clearance for…
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FDA approval · 2016-12-09FDA Approved: VIVITROL — Supplemental Application (Alkermes, Inc.)
The FDA approved a supplemental application for VIVITROL (naltrexone) from Alkermes, Inc., indicating an updated indication or labeling via …
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CLINICAL_TRIALS research · 2016-12-07Clinical Trial Update: Deep Brain Stimulation of the Nucleus Accumbens as a Novel Treatment in Severe Opioid Addiction [EARLY_Phase 1]
This early-phase 1 clinical trial is evaluating deep brain stimulation of the nucleus accumbens as a novel treatment for severe opioid use d…
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CLINICAL_TRIALS trial_result · 2016-12-06Clinical Trial Update: A Drug Treatment for Cocaine Users Who Are Also on Methadone Maintenance Treatment [NA]
This clinical trial update involves a drug treatment for individuals with cocaine dependence who are on methadone maintenance; the study was…
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CLINICAL_TRIALS trial_result · 2016-12-05Clinical Trial Update: Abuse Liability of Suboxone Versus Subutex [Phase 3]
Phase 3 trial comparing the abuse liability of Suboxone (buprenorphine/naloxone) versus Subutex (buprenorphine) in opioid-related disorders;…
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CLINICAL_TRIALS trial_result · 2016-12-05Clinical Trial Update: Phase IIa Study of AV411, a Glial Activation Inhibitor, for Opioid Withdrawal [Phase 2]
Phase IIa study of AV411 (ibudilast), a glial activation inhibitor, for opioid withdrawal has completed with results posted.
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CLINICAL_TRIALS trial_result · 2016-11-30Clinical Trial Update: FMRI of Stress and Addictive Disorders
A completed Yale University study used functional MRI to examine brain responses to stress in individuals with cocaine use disorder, opioid …
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CLINICAL_TRIALS trial_result · 2016-11-07Clinical Trial Update: Clinical Rescue Protocol - 2 [Phase 2]
A Phase 2 clinical trial on opioid use disorder conducted by UCLA has completed.
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FDA approval · 2016-10-31FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)
FDA approves a supplemental application for a buprenorphine and naloxone product manufactured by PAI Holdings for the treatment of opioid us…
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FDA approval · 2016-10-31FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
FDA approved a supplemental application for Methadone Hydrochloride by VistaPharm, LLC, enabling the generic product to be marketed. This ac…
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FDA approval · 2016-10-28FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for methadone hydrochloride (SpecGx LLC), confirming continued approval and availability of this gen…
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CLINICAL_TRIALS trial_result · 2016-10-26Clinical Trial Update: Methylnaltrexone Pharmacokinetics in Neurointensive Care Patients [Phase 1]
Phase 1 pharmacokinetic study of methylnaltrexone in neurointensive care patients has completed.
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CLINICAL_TRIALS research · 2016-10-14Clinical Trial Update: PINS Stimulator System for Deep Brain Stimulation of the Nucleus Accumbens to Treat Severe Opioid Addiction [EARLY_Phase 1]
Early-phase clinical trial update for the PINS Stimulator System delivering deep brain stimulation to the nucleus accumbens for opioid use d…
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CLINICAL_TRIALS research · 2016-10-06Clinical Trial Update: Evaluation of Drug Utilization Patterns for Extended Release/Long Acting Opioids and Comparator Products
A clinical trial update evaluating how extended-release/long-acting opioids and comparator products are utilized under the ER/LA REMS progra…
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CLINICAL_TRIALS research · 2016-10-05Clinical Trial Update: ER/LA Opioid Surveillance for Emergency Department Visits and Hospitalizations for Overdose and Poisoning
This update describes surveillance under the ER/LA Opioid REMS Program monitoring emergency department visits and hospitalizations for overd…
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FDA approval · 2016-10-04FDA Approved: ZUBSOLV — Supplemental Application (Orexo US, Inc.)
FDA approved a supplemental application for ZUBSOLV (buprenorphine/naloxone) by Orexo US, Inc.
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FDA approval · 2016-09-30FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for methadone hydrochloride from Hikma Pharmaceuticals USA Inc.