According to Indivior, the French regulatory agency Agence nationale de sécurité du médicament et des produits de santé (ANSM) has approved the company’s MAA for Nalscue naloxone hydrochloride nasal spray for the reversal of opioid overdose. Nalscue had been available in France under a Temporary Authorization for Use since July 2016.
Indivior Chief Medical Officer Ponni Subbiah commented, “As opioid overdoses continue to have a profound impact on communities within France, Nalscue may help make every second count by potentially allowing anyone, not just medical professionals, to administer life-saving treatment at the scene of an overdose.”
Adapt Pharma filed an MAA for its Narcan naloxone nasal spray in Europe in February 2017. Narcan has been approved in the US since November 2015. That same month, Indivior received a complete response letter from the FDA for its naloxone nasal spray.
Read the Indivior press release.