Naloxone Nasal Spray Seeks FDA Nod

The FDA is considering approval for an intranasal formulation of the opioid overdose antidote naloxone (Narcan).

Naloxone has been the standard of emergency treatment for opioid overdose for nearly 45 years. However, only injectable formulations of naloxone are currently approved for use in the United States.

Now, the FDA has granted priority review to Adapt Pharma’s naloxone hydrochloride nasal spray, which was previously given a fast track designation.

This Narcan nasal spray was developed in collaboration with specialty pharmaceutical company Lightlake Therapeutics and the National Institute on Drug Abuse.

Due to naloxone’s duration of action, the patient must be kept under continued surveillance and repeated doses should be administered as needed while awaiting emergency medical care.

Patients who have pre-existing cardiac disease or have received medications with potential adverse cardiovascular effects should be closely monitored in an appropriate health care setting.

In the postoperative setting, hypotension, hypertension, ventricular tachycardia and fibrillation, dyspnea, pulmonary edema, and cardiac arrest have been identified during naloxone use.

Excessive doses of naloxone hydrochloride in postoperative patients have significantly reversed analgesia and caused agitation.