Mundipharma AG Announces EU Regulatory Submission For Nyxoid

Published: Nov 02, 2016

? Mundipharma makes first EU regulatory submission for Nyxoid® (intranasal naloxone spray) for the reversal of opioid overdose

? Novel formulation designed to support take-home naloxone programmes and provide ‘first responders’ in overdose situations with an easy to use, needle-free option

? Drug-induced deaths represent a significant public health problem in the EU, the majority of which are associated with heroin1

Cambridge, UK – 2 November, 2016 – Mundipharma today announced the submission of a Marketing Authorisation Application (MAA) for Nyxoid® (intranasal naloxone 1.8 mg in 0.1 ml)2 to the European Medicines Agency (EMA), seeking approval for the emergency reversal of opioid overdose.

Naloxone has been used in routine practice to reverse the effects of opioid overdose for more than 40 years,3 and is included in the World Health Organisation (WHO) List of Essential Medicines.4 An intranasal formulation has been developed by Mundipharma in order to provide potential ‘first responders’ in overdose situations with an easy to use, needle-free option that is suitable for use in a take-home naloxone setting.

Rachel Gooch, Head of Addiction Therapy at Mundipharma International Limited, said: “We know that in emergency circumstances, rapid administration of a reversal agent is critical to preserving life. Take-home programmes are intended to increase the availability of naloxone in places where overdoses are most likely to occur, and provide prompt treatment that can save lives. We are pleased to be playing a role in providing essential medicines like naloxone, as well as taking a significant step towards building a portfolio of treatment options in addiction medicine.”

Mundipharma’s submission is based on data from a recently performed 5 part, single site, open label, randomised, single dose, crossover study involving 38 healthy volunteers. This study showed that Nyxoid is bioequivalent to injectable naloxone as a first line treatment for opioid overdose, with an intranasal 1.8 mg dose* anticipated to deliver therapeutic concentrations comparable with a 0.4 mg intramuscular naloxone, currently regarded as the standard of care in the event of opioid overdose.5 The product is well tolerated with a similar safety profile to that of injectable naloxone.5

* Nyxoid contains 1.8 mg naloxone, which is equivalent to 2 mg naloxone hydrochloride.

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