Mountain Rescue Study Launches to Investigate Use of Penthrox® (Methoxyflurane) for Trauma-related Pain in Hostile Environments

FOR EUROPEAN MEDICAL AND TRADE MEDIA ONLY

- Study will enrol 200 adult patients with limb trauma who are
rescued by helicopter
- Efficacy, tolerability and practicality of use of the inhaled
analgesic in hostile mountain environments to be investigated

Cambridge, England (ots/PRNewswire) - The Mundipharma network of
independent associated companies announced today that the first
patient has been enrolled into a new study investigating the efficacy
of Penthrox® (methoxyflurane, MEOF) in conscious, stable adult
patients with moderate-to-severe trauma-related pain rescued from
hostile, mountainous areas.1 The METEORA trial is a Phase IIIb,
prospective, single-arm, multicentre trial in 200 adult patients with
limb trauma who are rescued by the Helicopter Emergency Medical
Service (HEMS) in Italy.1

The trial will assess the reduction in pain intensity (using the
visual analogue scale [VAS] 0-100 mm) for patients treated with
inhaled MEOF; and whether additional pain-relieving medication is
needed.1 The practicality of MEOF use in an emergency rescue
situation, patient satisfaction and any adverse events will also be
evaluated.1 The primary endpoint is the percentage of patients
achieving at least 30% improvement in VAS pain intensity within the
first 10 minutes of MEOF administration.1

Lead Investigator, Professor Franco Marinangeli commented: "In
emergency rescue situations rapid, effective pain relief is vital.
Not only does it reduce the patients' stress and discomfort, it can
also make it easier to assess, treat and transport them. Research
shows that under-treatment of trauma pain in the pre-hospital
emergency setting remains a significant problem. I am pleased to be
leading this study into the use of Penthrox in this new setting."

Antonella Sblendido, Medical Advisor, Mundipharma added: "Penthrox
has been widely used by Ambulance services in Australia since 1975
and is now approved in Europe for the emergency relief of moderate to
severe trauma-related pain in conscious adults. Given its
portability, ease of use and rapid onset, we felt it was important to
investigate its use in hostile environments, where more pain-relief
options are needed."

Giovanni Sbrana, Principal Investigator, Grosseto Helicopter
Emergency Medical Service said: ''We are excited to be involved in
the study and to have enrolled the first patient. Our Helicopter
Service operates in a rural area in Tuscany with a very low-density
population where we perform more than 1,000 rescue missions a year.
Helicopter is the only way to reach some patients and to give them
lifesaving therapies and pain relief. As was the case with our first
METEORA patient, we often have to deal with challenging weather
conditions which means that we need to stabilise the patient quickly
and remove them in order to avoid a helicopter becoming unavailable.
Therefore we need a treatment with fast onset and convenient
administration, and we look forward to seeing the results as the
study progresses."

To find out more about the study visit:
https://link.springer.com/article/10.1007/s12325-018-0816-8

To read the full press release please visit:
www.mundipharma.com/media/news/

This medicine is subject to additional monitoring. This will allow
quick identification of new safety information. You can help by
reporting any side effects you may get to your local medicines
regulatory authority.

PENTHROX® is a registered trade mark of Medical Developments
International Limited and is used under licence.

Reference

[1]. Marinangeli F, et al. Adv Ther 2018;35:2081.

JOB CODE: MBL/PROX-19004A(1), DATE OF PREPARATION: MARCH 2019

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ots Originaltext: Mundipharma International
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Original-Content von: Mundipharma International, übermittelt durch news aktuell