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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 Biopharma
SPARK BiopharmaKorea - Seoul
1 program
Spark Biomedical Roo Transcutaneous Auricular NeurostimulationN/A1 trial
Active Trials
NCT04588519Completed8Est. Dec 2020
Spark Biomedical
Spark BiomedicalTX - Dallas
1 program
Spark Biomedical Roo Transcutaneous Auricular NeurostimulationN/A

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.