US FDA declines to approve Orexo's opioid overdose drug (updated)

Orexo AB

16/07/2024 21:17

(Adds details from paragraph 2 onward)
       July 16 (Reuters) - The U.S. Food and Drug
Administration has declined to approve Orexo AB's  ORX.ST 
high-dose prescription drug for opioid overdose, the company
said on Tuesday.
    The FDA, in a so-called complete response letter, cited the
need for an additional Human Factors (HF) study for its
decision, the company said.
    The health regulator also requested additional technical
data on the final commercial product.
        The company's drug, OX124, is a nasal rescue medication
for opioid overdose containing a high dose of naloxone.
        In May, the company flagged a possible delay after
receiving some questions from the FDA regarding the use and
instructions of the device, adding that it was aiming for a
potential launch later this year or early 2025.

 (Reporting by Vallari Srivastava, Sriparna Roy and Unnamalai L
in Bengaluru; Editing by Tasim Zahid and Shailesh Kuber)
 ((Sriparna.Roy@thomsonreuters.com;))