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CRAIGAVON, NORTHERN IRELAND, 22 JUNE 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 United Kingdom. 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).[i],[ii] 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 Ben Bloom, Consultant in Emergency Medicine at The Royal London Hospital, co-investigator on the MAGPIE Study said: “This marks an important advancement in the options available to us for managing pain in children within emergency care. Building on robust evidence from adult studies, we now have clear data supporting the effectiveness and tolerability of methoxyflurane for paediatric patients in clinical settings. This extension to the license means we can offer rapid pain relief and help improve the overall care experience for young 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 UK — 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.” Note to editors About Penthrox (methoxyflurane) Penthrox® (methoxyflurane) is a rapidly-acting inhaled analgesic agent which is self- administered under the supervision of a person trained in its administration.2 Methoxyflurane has been used extensively in Australia and New Zealand as emergency analgesia for more than 40 years, and is licensed in a number of European countries for the emergency relief of moderate-to-severe pain associated with trauma in conscious adult patients. About Galen Galen is a privately owned pharmaceutical sales and marketing company, headquartered in Craigavon (Northern Ireland) and product presence in 25 locations covering each continent across the globe. With over 55 years’ experience, we have 75+ products across a diverse range of therapy areas. Galen has ambitious expansion plans across new territories and therapeutic areas through the acquisition of new companies and product portfolios as well as product partnerships. Galen aims to provide extraordinary service to healthcare professionals, partners, and patients to create real, long-term value and benefit the health of future generations. For further information please visit: www.galen-pharma.com About Almac Group Galen is a member of the Almac Group. The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across, and beyond, the drug development lifecycle to the pharmaceutical and biotech sectors globally. The Group is wholly owned by the McClay Foundation, whose overarching aim is to make a meaningful improvement and advancement in human health. The international company is a privately owned organisation that has grown organically over the past five decades and now employs over 7,000 highly skilled personnel across 18 facilities including Europe, the US and Asia. For further information please visit www.almacgroup.com References: [1] Hartshorn S, Barrett MJ, Bloom B, et al. Treatment of acute trauma-related pain in children and adolescents with methoxyflurane (Penthrox®) compared to placebo (MAGPIE): a randomised clinical trial. Injury. 2025;56(12):112830. https://www.sciencedirect.com/science/article/pii/S0020138325006886 [1] Penthrox (methoxyflurane) Summary of Product Characteristics (SmPC). (June 2026). MAT-PEN-UK-000823. Date of preparation: June 2026.
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