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, March 27, 2019 /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.
. Marinangeli F, et al. Adv Ther 2018;35:2081.
JOB CODE: MBL/PROX-19004A(1), DATE OF PREPARATION: MARCH 2019