No FDA Nod for Second Nasal Naloxone in Opioid Overdose

Susan Jeffrey

November 25, 2015

The US Food and Drug Administration (FDA) has declined approval of the New Drug Application for an intranasal naloxone spray for the emergency treatment of known or suspected opioid overdose.

The manufacturer, Indivior Inc, a subsidiary of Indivior PLC in Slough, United Kingdom, announced it received a Complete Response Letter from the agency in a statement released November 24.

"The FDA's response was principally focused on clinical pharmacology that found the early stage uptake of naloxone did not fully meet the FDA's threshold as determined by the reference product (0.4 mg naloxone by intramuscular injection)," the Indivior statement noted.

"Indivior is evaluating the FDA's comments to determine our next steps to address the FDA's findings," the company said.

Another intranasal naloxone product (Narcan, Adapt Pharma Inc) was approved by the FDA November 18 under a fast-track approval process.

Naloxone hydrochloride is given by intramuscular injection to stop or reverse the effects of opioid overdose, and in particular respiratory depression. It usually works within 2 minutes but must be given quickly to prevent death.

The nasal form is thought to be easier for first responders and others to deliver and eliminates the threat of contaminated needlesticks. Until now, unapproved naloxone kits have combined the injectable form of naloxone with an atomizer to administer the drug nasally. The FDA cautioned that the person administering the drug should still seek immediate medical attention for the patient.

"Combating the opioid abuse epidemic is a top priority for the FDA," Stephen Ostroff, MD, acting FDA commissioner, said in an FDA news release announcing approval of Narcan. "We cannot stand by while Americans are dying. While naloxone will not solve the underlying problems of the opioid epidemic, we are speeding to review new formulations that will ultimately save lives that might otherwise be lost to drug addiction and overdose."