Naloxon-Nasenspray NYXOID® (Mundipharma) erhält Empfehlung für die europäische Zulassung
Naloxon-Nasenspray NYXOID® (Mundipharma) erhält Empfehlung für die europäische Zulassung
On 14 September 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Nyxoid, intended for the treatment of opioid overdose. The applicant for this medicinal product is Mundipharma Corporation Limited.
Nyxoid will be available as a nasal spray (1.8 mg). The active substance of Nyxoid is naloxone, an antidote that acts as opioid receptor antagonist (ATC code: V03AB15).
The benefits with Nyxoid are its ability to reverse symptoms of opioid overdose. The most common side effects are nausea and opioid withdrawal syndrome.
Nyxoid is a hybrid medicine1 of Naloxon HCl (solution for injection) which has been authorised in the EU since 2006. Nyxoid contains the same active substance as Naloxon HCl, but it is given into the nostrils. (EMA – European Medicines Agency, EMA/CHMP/594248/2017, 14.09.2017)