US FDA declines to approve Orexo's opioid overdose drug
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[July 17, 2024]
(Reuters) -The U.S. Food and Drug Administration (FDA) has
declined to approve Orexo AB's high-dose prescription drug for opioid
overdose, the company said on Tuesday.
The health regulator, in a so-called complete response letter, has
sought an additional Human Factors (HF) study and additional technical
data on the final commercial product, the company said.
Orexo said the FDA's request for additional technical data was
unexpected, and added that it will work with the agency to enable a
resubmission of the drug's marketing application.
The Swedish 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 related to
OX124, adding that it was aiming for a potential launch later this year
or early 2025.
Several drugmakers sell the overdose reversal drug, naloxone. FDA has
approved the over-the-counter sale of Emergent BioSolutions' Narcan,
while Harm Reduction Therapeutics' naloxone-based nasal spray, RiVive is
approved for prescription-free sale.
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![](../images/071724PIX/health5.jpg)
Signage is seen outside of the Food and Drug Administration (FDA)
headquarters in White Oak, Maryland, U.S., August 29, 2020.
REUTERS/Andrew Kelly/File Photo
![](http://archives.lincolndailynews.com/2024/Jul/17/images/ads/current/bees_lda_HEROES_2024.png) Walgreens Boots Alliance also
launched its naloxone-based drug in May. The U.S. pharmacy chain
operator sells theOTC opioid reversal drug at a retail price of
$34.99 per pack, with each pack containing two single doses of 4
milligrams each.
(Reporting by Vallari Srivastava, Sriparna Roy and Unnamalai L in
Bengaluru; Editing by Tasim Zahid and Shailesh Kuber)
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