- (PLX AI) – Orexo pivotal trial OX124-002 meets the primary endpoints in the 4-period crossover, comparative bioavailability study in healthy volunteers.
- • OX124 showed a significantly faster and higher absorption of naloxone compared to intramuscular dosing with the injection reference product
- • OX124 is designed to help in the fight against overdoses caused by the most powerful synthetic opioids that are behind the vast majority of fatal overdoses in the US
- • Based on the successful outcome of the study, Orexo is expecting to file a New Drug Application with the US Food and Drug Administration (FDA) in H2 2022
- • Following FDA approval, a US launch will be initiated in H2 2023
Quelle: PLX AI