Study identification

EU PAS number

EUPAS13040

Study ID

30864

Official title and acronym

Post Authorisation Safety Study (PASS) to Evaluate the Risks of Hepatotoxicity and Nephrotoxicity from Administration of Methoxyflurane (Penthrox®) for Pain Relief in Hospital Accident & Emergency Departments in the United Kingdom (Penthrox-PASS)

DARWIN EU® study

No

Study countries

United Kingdom

Study description

Medical Developments UK Ltd (MDI) has applied for marketing authorisation of a liquid oral inhalation preparation of methoxyflurane (Penthrox®), for emergency relief of moderate to severe pain in conscious adult patients with trauma and associated pain, via the decentralised procedure with the Medicines and Healthcare products Regulatory Agency (MHRA). Certain safety issues (hepatotoxicity and nephrotoxicity) have been identified by the MHRA medical assessor as potential public health risks. A PASS (and risk minimisation measures which are being evaluated separately from this study) has been recommended with the primary purpose of confirming the absence of a significant risk of hepatotoxicity with use of methoxyflurane in Accident and Emergency (A&E) during routine pre-hospital clinical practice, and in hospital A&E departments.

Study status

Ongoing
Research institutions and networks

Institutions

OXON Epidemiology
Spain
United Kingdom
First published:
15/03/2024
Institution Laboratory/Research/Testing facility Non-Pharmaceutical company ENCePP partner

Networks

Contact details

Nawab Qizilbash

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Medical Developments International
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Non-EU RMP only