Orexo shares new information on OX124, a high-dose naloxone rescue medication in development for opioid overdose

UPPSALA, Sweden, July 16, 2024 /PRNewswire/ — Orexo AB (publ.), (STO: ORX) (OTCQX: ORXOY), today announces that the company has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for OX124, a high-dose naloxone rescue medication in development for opioid overdose. The NDA was submitted to the FDA on September 18, 2023. The CRL indicates the need for an additional Human Factors (HF) study, which is in line with previous communication. Furthermore, additional technical data on the final commercial product has been requested. The CRL does not indicate a need for additional clinical or non-clinical studies.

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