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Neonatal Abstinence Syndrome

2
Pipeline Programs
5
Companies
4
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
0
1
1
0
0
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

5 companies ranked by most advanced pipeline stage

Pediatrix Therapeutics
Pediatrix TherapeuticsChina - Shanghai
1 program
1
BuprenorphinePhase 21 trial
Active Trials
NCT01708707Completed29Est. Oct 2017
Chiesi
ChiesiBrazil - Santana de Parnaíba
1 program
1
BuprenorphinePhase 1/21 trial
Active Trials
NCT03608696Completed10Est. Jul 2019
Human BioSciences
Human BioSciencesWV - Martinsburg
1 program
MethadoneN/A1 trial
Active Trials
NCT01754324Completed20Est. Dec 2013
Spark Biomedical
Spark BiomedicalTX - Dallas
1 program
Spark Biomedical Roo Transcutaneous Auricular NeurostimulationN/A
SPARK Biopharma
SPARK BiopharmaKorea - Seoul
1 program
Spark Biomedical Roo Transcutaneous Auricular NeurostimulationN/A1 trial
Active Trials
NCT04588519Completed8Est. Dec 2020

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Pediatrix TherapeuticsBuprenorphine
ChiesiBuprenorphine
SPARK BiopharmaSpark Biomedical Roo Transcutaneous Auricular Neurostimulation
Human BioSciencesMethadone

Clinical Trials (4)

Total enrollment: 67 patients across 4 trials

NCT01708707Pediatrix TherapeuticsBuprenorphine

Comparison of Buprenorphine to Morphine in Treatment of Neonatal Abstinence Syndrome (NAS)

Start: Dec 2012Est. completion: Oct 201729 patients
Phase 2Completed
NCT03608696ChiesiBuprenorphine

Buprenorphine Pharmacometric Open Label Research Study of Drug Exposure

Start: Aug 2018Est. completion: Jul 201910 patients
Phase 1/2Completed
NCT04588519SPARK BiopharmaSpark Biomedical Roo Transcutaneous Auricular Neurostimulation

tAN to Mitigate Withdrawal Behaviors in Neonates

Start: May 2020Est. completion: Dec 20208 patients
N/ACompleted
NCT01754324Human BioSciencesMethadone

The Pharmacokinetics of Oral Methadone in the Treatment of Neonatal Abstinence Syndrome

Start: Dec 2012Est. completion: Dec 201320 patients
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

5 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.