Less than a week after the FDA approved Adapt Pharma’s Narcan naloxone nasal spray for the treatment of opioid overdose, the agency has issued a Complete Response Letter to Indivior’s NDA for its naloxone nasal spray, Indivior said. Indivior submitted the NDA in July 2015.
According to the company, “The FDA’s response was principally focused on clinical pharmacology that found the early stage uptake of naloxone nasal spray did not fully meet the FDA’s threshold as determined by the reference product (0.4 mg naloxone by intramuscular injection).”
Indivior CEO Shaun Thaxter commented, “We are closely reviewing the FDA’s response. Our commitment to improving patient outcomes remains steadfast, and as part of this, our work with stakeholders across communities will continue.”
Read the Indivior press release.
