An Observational Post-Authorization Safety Study (PASS) of MOVENTIG® (Naloxegol) Among Patients Aged 18 Years and Older Treated with Opioids Chronically

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/17821
• EU PAS number:
  EUPAS12669
• Study ID:
  17821
• Official title and acronym:
  An Observational Post-Authorization Safety Study (PASS) of MOVENTIG® (Naloxegol) Among Patients Aged 18 Years and Older Treated with Opioids Chronically
• DARWIN EU® study:
  No
• Study countries:
  Netherlands

  United Kingdom
• Study description:
  This study is designed to provide additional data to characterize the safety of naloxegol in the indicated population and within at risk vulnerable populations identified in the naloxegol RMP by describing type and frequency of identified and potential risks (including bowel perforation, acute myocardial infarction, stroke, cardiovascular-specific mortality, all-cause mortality, hypertension, opioid withdrawal, abdominal pain, diarrhea, syncope, and change in pain severity) in patients ≥18 years of age who were treated with opioids chronically and subsequently treated with naloxegol in routine post-authorization use.
• Study status:
  Finalised

Research institutions and networks

Institutions

Evidera

United Kingdom

Evidera

United Kingdom

The PHARMO Institute for Drug Outcomes Research (PHARMO Institute)

Netherlands

IMS Health

Study timelines

Date when funding contract was signed

Actual: 13/10/2015

Study start date

Actual: 01/12/2015

Date of final study report

Planned: 15/12/2023

Actual: 02/12/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Kyowa Kirin

Study protocol

Initial protocol

D3820R00009 CSP - PRAC 07312015 final

Updated protocol

m1-8-2 D3820R00009 PASS CSP_v6.1_29Mar2021

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)