Marketing authorisation for Penthrox handheld inhaler issued in France

Mundipharma International Limited today announced that Penthrox^® (low dose methoxyflurane) has been granted marketing authorisation in France for the emergency relief of moderate to severe pain in conscious adult patients with trauma and associated pain.

Penthrox is manufactured by the Australian company Medical Developments International Limited who received the French marketing authorisation. Mundipharma has the exclusive product rights in 39 European markets including France, Belgium, Germany, Italy and Spain, but excluding Hungary, Republic of Ireland and the United Kingdom.

“Mundipharma has a proud heritage in pain management and is committed to advancing important new therapeutics in this space,” commented Kate Hurtig, Head of Pain at Mundipharma International. “Penthrox is our first analgesic for use in the emergency care setting. It offers the potential to manage emergency pain in a completely different way to existing treatment options and we are excited about the prospect for growth which that brings.”

Currently in Europe, pain remains undertreated in both the pre-hospital and emergency department settings, where prevalence in the latter can be over 90%.

Penthrox is a lightweight, self-administered, handheld inhaler that delivers 3ml methoxyflurane. Patients can titrate the amount of Penthrox they inhale, allowing them to control their own pain.

Penthrox has been extensively used for over 30 years in Australia and New Zealand, therefore it has an established safety profile and efficacy data.