The EMA Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Mundipharma’s MAA for Nyxoid naloxone nasal spray for the reversal of opioid overdose.
Currently, no intranasal naloxone formulations are approved for use across the entire EU. Indivior’s Nalscue nasal spray was approved in France in July 2017. Adapt Pharma submitted an MAA for its Narcan naloxone nasal spray in February 2017; Narcan has been approved in the US since 2015.
Mundipharma Head of Addiction Therapy Rachel Gooch commented, “This positive opinion is a significant step for Mundipharma and we look forward to the final European Commission decision in Q4 2017. For many years naloxone has been a cornerstone of the emergency reversal of opioid overdose, however it must be delivered rapidly in order to preserve life. We know that a longer period between overdose and the arrival of emergency services can lead to a greater risk of severe damage or death. We therefore expect the availability of an easy to use, needle-free option, suitable for use in take home setting, to be a welcome additional treatment option with potential to reduce the overall number of opioid-related overdose deaths in Europe.”
Read the Mundipharma press release.
