CRAIGAVON, NORTHERN IRELAND, 2 MARCH 2026 – Galen Ltd. today announced that Penthrox® (methoxyflurane 3ml), a self-administered inhaler, which is indicated for emergency relief of moderate to severe pain in conscious patients with trauma and associated pain, is now licensed for use in children aged six years and over in the Republic of Ireland. This provides emergency medicine healthcare professionals with the ability to deliver this emergency analgesic to a broader range of patients suffering from trauma pain, both in hospital and in pre-hospital settings.
Methoxyflurane efficacy and safety in children has been evaluated in the MAGPIE study; a phase III, double-blind, randomised, placebo-controlled study which involved multiple centres across the United Kingdom and Ireland. One hundred and ninety two patients aged 6 to < 18 years of age attending the emergency department for minor trauma were randomised and treated (92 received methoxyflurane and 100 received placebo). The change in Visual Analogue Scale (VAS) pain scores at 15 mins in the 9 to < 18 year old age group, was greater for the methoxyflurane group (20.0 mm) when compared to the placebo group (13.2 mm), (95% CI: -12.5, -1.2) mm; p=0.018. The change in VAS score at 15 min was also greater for the overall 6 to < 18 years age population in the methoxyflurane group (21.9 mm) when compared to the placebo group (14.9 mm), (95% CI: -12.5, -1.5) mm; p=0.013. Overall, the greatest treatment effect was seen at 20 minutes (estimated treatment effect of -10.8 [95% CI: -16.7, -4.9] mm; p<0.001). In the overall population a lower proportion of patients in the methoxyflurane group (3.3%) requested rescue medication up to 20 minutes when compared to the placebo group (21.0%) (p<0.001), and at any time following treatment start (methoxyflurane: 9.8%, placebo 30.0%, p<0.001). The majority of adverse events were mild in intensity and non-serious with the most common being dizziness (41.3% in methoxyflurane group vs 12.0% in placebo group) and euphoric mood (12.0% in methoxyflurane group vs 0.0% in placebo group).1,2 This pivotal study demonstrated that methoxyflurane is efficacious for the treatment of acute pain in children and adolescents aged 6 to < 18 years with minor trauma, with a safety profile consistent with the established safety profile of methoxyflurane observed in adults.1,2
Dr Michael Barrett, Paediatric Emergency Medicine Consultant at Children’s Health Ireland, co-investigator on the MAGPIE Study said: “This is a significant step forward for the medicines we can use for children in pain in the emergency setting. It builds on previous adult trials and now demonstrates the product’s effectiveness and safety profile for children in clinical settings. It offers an option to address pain quickly and improve the care experience for patients and their families.”
Dr Dennise Broderick, Managing Director and President of Galen said: “We are delighted that methoxyflurane is now approved for use in children aged six and over in the Republic of Ireland — a major advancement in paediatric emergency care, allowing healthcare professionals to offer a non-invasive treatment for managing the pain of young patients. At Galen, our vision is to improve health outcomes for all generations, and this milestone reflects that commitment. We extend our sincere thanks to all those involved in the MAGPIE study, whose dedication and expertise made this advancement possible.”
