FDA Issues Complete Response Letter to Indivior for Opioid Overdose Nasal Spray
UK-based Indivior received an FDA complete response letter for issues in its NDA for naloxone nasal spray, an emergency treatment for opioid overdose.
The FDA’s response mostly focuses on clinical pharmacology, and the agency says the early stage uptake of naloxone did not fully meet its threshold compared with the reference product, the company says.
Indivior CEO Shaun Thaxter says the company is closely reviewing the FDA’s response to determine next steps.
The news comes just days after the FDA approved Adapt Pharma’s Narcan (naloxone) nasal spray for the same indication.