Mundipharma has announced enrollment of the first patient in the Phase 3b METEORA trial of Penthrox inhaled methoxyflurane in patients with limb trauma who have been rescued by helicopter from hostile terrain and are suffering from moderate-to-severe pain.
The study is expected to enroll 200 adult patients rescued by Italian helicopter emergency medical services, with the percentage of patients experiencing a minimum of 30% reduction in pain within 10 minutes of inhaling the methoxyflurane as the primary endpoint.
Mundipharma has the rights to market Penthrox in most of Europe. According to Penthrox developer Medical Developments International, the inhaler is approved for the treatment of moderate to severe trauma pain in over 30 countries. In the US, the FDA placed a hold on the Penthrox clinical development program in July 2018.
Mundipharma Medical Advisor Antonella Sblendido said, “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.”
Principal Investigator Giovanni Sbrana of Grosseto Helicopter Emergency Medical Service commented, ”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 stabilize 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.”
Read the Mundipharma press release.
