Orexo expects FDA filing of OX124 mid 2022 - OX124 is designed to reverse the effect of the most powerful synthetic opioids - Synthetic opioids are behind the majority of fatal overdoses in the US, a development expected to increase due to Covid-19 - New Drug Application (NDA) filing expected mid 2022 UPPSALA, Sweden, Jan. 29, 2021 /PRNewswire/ -- Orexo AB (publ.), (STO: ORX) (OTCQX: ORXOY) today announces that it is expecting to file its flagship pharmaceutical pipeline asset OX124 with the US Food and Drug Administration mid-2022. OX124 is expected to follow the FDA's standard submission and review timelines, as the FDA did not grant Fast Track Designation to the product. Given the medical need to swiftly make powerful rescue medications available to those in need, Orexo will continue to work closely with the FDA to expedite the route to approval. The FDA's decision is not related to the product, but is based on an overall assessment whether the development program meets the strict requirements to receive Fast Track Designation.