MUNDIPHARMA

FOR EUROPEAN MEDICAL AND TRADE MEDIA ONLY

Mundipharma presents new data for the inhaled analgesic Penthrox^® (methoxyflurane)⁶ at the European Society for Emergency Medicine (EUSEM) Congress 2019, from 12–16 October. Five abstracts are being presented, advancing the understanding of the use of methoxyflurane in the treatment of moderate to severe trauma-related pain for adults in emergency settings in Europe:

MEDITA Study¹ #18647: the first study to directly compare the effectiveness of methoxyflurane to standard analgesic treatment (SAT) – IV morphine for severe pain, and IV paracetamol or ketoprofen for moderate trauma pain in Italy.

• Methoxyflurane was superior to IV morphine (severe pain) and IV paracetamol or IV ketoprofen (moderate pain) for the primary endpoint, defined as the change in pain intensity over the first 10 minutes (overall adjusted mean treatment difference: 5.94mm; 95% CI: 8.83, 3.06mm) following pain treatment administration.¹
• Methoxyflurane was rated as ‘excellent’, ‘very good’ or ‘good’ by significantly more patients in the methoxyflurane group, compared to the SAT group (72.7% vs 60.9%; p=0.001) and significantly more healthcare professionals rated the practicality of methoxyflurane as ‘excellent’, ‘very good’ or ‘good’, compared to SAT (90.3% vs 64.4%; p<0.001).¹

PenASAP Study⁵ #19302 : a placebo-controlled study comparing the effectiveness of methoxyflurane plus standard of care (SoC) analgesia vs SoC analgesia plus placebo for the management of moderate to severe trauma pain in France.

• Results demonstrate the superiority of methoxyflurane in combination with SoC vs placebo plus SoC, in achieving pain relief for patients with moderate to severe trauma pain. For the primary endpoint, the median time to pain relief, defined as 30mm or less on the visual analogue scale, was 35 minutes in the methoxyflurane plus SoC group (p<0.001) and was not reached in the SoC plus placebo group.⁵

InMEDIATE Study^2-4 #18659, #18660, #18661: sub-analyses from a study comparing methoxyflurane to existing SAT in acute moderate to severe trauma pain in Spain.

• Methoxyflurane use in the elderly (at least 65 years old) provided significantly faster pain relief than SAT (time to first pain relief of 5.55 vs 12.8 minutes, and time to first meaningful pain relief of 12.57 vs 25.07 minutes), respectively.²
• In patients with severe trauma-related pain (numerical rating scale score of 7 or more), decrease from baseline was significantly larger for methoxyflurane than SAT at all time points (3, 5, 10, 15 and 20 minutes) (p<0.001), with the largest treatment difference reported at 10 minutes.³
• In patients with acute trauma pain (numerical rating scale score of 4 or more) who received first-step IV analgesic, the decrease from baseline was significantly larger for methoxyflurane than SAT at all time points (3, 5, 10, 15 and 20 minutes) (p<0.001), with the largest treatment difference reported at 10 minutes.⁴

Methoxyflurane was generally well tolerated in all the studies, with most adverse events (AEs), primarily dizziness, being mild and transient but occurring more frequently than in the comparator groups.^2-6 In the PenASAP study, two severe AEs occurred in the methoxyflurane plus SoC group, including one that was assessed as treatment-related.⁵

“We are very excited by these data demonstrating the superiority of methoxyflurane when compared directly with standard treatment, or compared with placebo when used in addition to SoC for moderate-to-severe trauma pain, in real-world settings in European countries” said Sara Dickerson, Medical Affairs Lead for Mundipharma. “We know that trauma pain is too often undertreated, or even untreated, which can be very distressing for patients and can lead to long-term effects. Results from these studies support the use of methoxyflurane as a simple, fast and effective non-opioid treatment option for adult patients experiencing trauma pain.”

^▼ 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.

-Ends-

Notes to editors

About Penthrox^® (methoxyflurane)

Penthrox is a small, light-weight, hand-held, inhaled non-opioid analgesic.^6,7 It is indicated in Europe for the emergency relief of moderate to severe pain in conscious adults with trauma and associated pain.^6,8 It is a self-administered analgesic (under supervision) and provides rapid pain relief within three minutes⁹ or six to ten inhalations.^10,11 Methoxyflurane as an analgesic has been used by more than six million people over the course of 40 years, in Australia and New Zealand.¹² It has an established tolerability profile and a body of supporting evidence in adult trauma pain.^13,14

Mundipharma International Corporation Limited has exclusive rights to Penthrox in 40 European markets, including France, Germany, Italy and Spain, but excluding the Republic of Ireland and the United Kingdom.

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

Click here to watch an animation about the management of trauma pain in Europe: www.mundipharma.com/media_video/taking-the-pain-out-of-trauma/

About Management of Trauma Pain in the Pre-Hospital Setting

33 million people across Europe visit the hospital emergency department due to injuries every year.¹⁵ Trauma pain requires fast, effective pain relief (analgesia).⁷ Although inadequate pain treatment can cause clinical deterioration, pain is undertreated in both the emergency department and pre-hospital setting, and remains a significant problem.^7,16 Current analgesics have limitations in pre-hospital settings and there is a need for fast-acting, non-invasive, non-narcotic analgesia.^7,17

About the Mundipharma Network

Mundipharma is a global network of privately-owned independent associated companies whose purpose is to move medicine forward. With a high performing and learning organisation that strives for innovation and commercial excellence through partnerships, we successfully transformed and diversified our European portfolio of medicines to create value for patients, payers and wider healthcare systems across important therapeutic areas such as Diabetes, Respiratory, Oncology, Pain and Biosimilars.

References

1 Serra S, Ruggiano G, Fabbri A, et al . Methoxyflurane versus standard analgesic treatment for acute trauma-related pain in the emergency setting: results of a randomised, controlled study in Italy (MEDITA). Presented at EUSEM 2019. Abstract #18647, Poster P37.

2 Capilla Pueyo R, Fernandez Alonso C, Garcia S, et al . Methoxyflurane, an efficient and well tolerated analgesic for elderly patients, compared with standard analgesic treatment: subgroup analysis of a phase IIIb randomised, controlled trial (InMEDIATE). Presented at EUSEM 2019. Abstract #18659 - OP014.

3 Fernández Alonso C, Garcia Collado S, Carballo Cardona C, et al . Low dose of inhaled Methoxyflurane: more effective and rapid-acting than standard analgesic treatment, also for severe trauma-related pain: subgroup analysis of a randomised controlled trial (InMEDIATE). Presented at EUSEM 2019. Abstract #18660 - SP090.

4 Carballo Cardona C, Capilla Pueyo R, Fernandez Alonso C, et al. Low dose of inhaled methoxyflurane is more effective with higher patient and clinician satisfaction than first-step intravenous analgesic treatment for acute trauma-related pain: subgroup analysis of a phase IIIb randomised controlled trial (InMEDIATE). Presented at EUSEM 2019. Abstract #18661 - OP015.

5 Ricard-Hibon A, Lecoules N, Savary D, et al . A randomised, double blind placebo-controlled study of methoxyflurane plus standard of care analgesia versus placebo plus standard of care analgesia for moderate to severe pain associated with trauma (The PenASAP Study). Presented at EUSEM 2019. Abstract #19302 - OP008.

6 eMC. Penthrox Summary of Product Characteristics. Available at: www.medicines.org.uk/emc/product/1939/smpc/print . Accessed October 2019.

7 Marinangeli F, Reggiardo G, Sblendido A, et al. Prospective, Multicentre Trial of Methoxyflurane for Acute Trauma-Related Pain in Helicopter Emergency Medical Systems and Hostile Environments: METEORA Protocol. Adv Ther 2018;35:2081-92.

8 Medical Developments International. ASX Announcement: Penthrox approved in another 22 European countries 2017. Available at: www.medicaldev.com/news/asx-announcement-penthrox-approved-another-22-european-countries/ Accessed: October 2019.

9 Borobia AM, Garcia Collado S, Carballo Cardona C, et al. Inhaled Methoxyflurane Provides Greater Analgesia and Faster Onset of Action Versus Standard Analgesia in Patients With Trauma Pain: InMEDIATE: A Randomized Controlled Trial in Emergency Departments. Ann Emerg Med 2019; https://doi.org/10.1016/j.annemergmed.2019.07.028

10 Coffey F, Wright J, Hartshorn S, et al. STOP!: a randomised, double-blind, placebo-controlled study of the efficacy and safety of methoxyflurane for the treatment of acute pain. Emerg Med J 2014;31:613-618.

11 Coffey F, Dissmann P, Mirza K, et al . Methoxyflurane Analgesia in Adult Patients in the Emergency Department: A Subgroup Analysis of a Randomized, Double-blind, Placebo-controlled Study (STOP!) Adv Ther 2016;33:2012-2031.

12 Porter KM, Dayan AD, Dickerson S, et al. The role of inhaled methoxyflurane in acute pain management. Open Access Emerg Med 2018;10:149-164.

13 Grindlay J, Babl FE. Efficacy and safety of methoxyflurane analgesia in the emergency department and prehospital setting. Emerg Med Australas 2009;21(1):4-11.

14 Jephcott C, Grummet J, Nguyen N, et al. A review of the safety and efficacy of inhaled methoxyflurane as an analgesic for outpatient procedures. Br J Anaesth 2018;120(5):1040-1048.

15 Eurosafe. Injuries in the European Union: 2013-2015. Available at: www.eurosafe.eu.com/uploads/inline-files/IDB%202013-2015_suppl%20to%206th%20edition%20Injuries%20in%20the%20EU.pdf . Accessed October 2019.

16 Berben SA, Meijs TH, van Dongen RT, et al . Pain prevalence and pain relief in trauma patients in the Accident & Emergency department. Injury 2008;39:578-585.

17 Sinatra R. Causes and Consequences of Inadequate Management of Acute Pain. Pain Med 2010;11:1859-1871.

MBL/PROX-19078a Date of preparation: OCTOBER 2019

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