Mundipharma submits MAA to EMA for approval of Nyxoid (intranasal naloxone 1.8 mg in 0.1 ml) for the emergency reversal of opioid overdose.
Mundipharma has announced the submission of a Marketing Authorisation Application (MAA) for Nyxoid (intranasal naloxone 1.8 mg in 0.1 ml)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, and is included in the World Health Organisation (WHO) List of Essential Medicines.
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.
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