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.
Walgreens Boots Alliance also launched its naloxone-based drug in May. The U.S. pharmacy chain operator sells the OTC opioid reversal drug at a retail price of $34.99 per pack, with each pack containing two single doses of 4 milligrams each.