Subject:
Intranasal Naloxone Product Approved by FDA

Short Description:

The opioid antagonist, naloxone, was first approved for opioid overdose treatment in 1971 and is available as an inexpensive injectable generic. In recent years, emergency responders have been using more easily administered intranasal version of naloxone. However, until now this formulation had to be improvised by attaching a naloxone vial onto a mucosal atomization device. While data support the safety and effectiveness of this type of device, this practice has been an off-label one and depends on “kits” that are not widely available.

Background:

On November 18, 2015, the Food and Drug Administration (FDA) granted a fast-tracked (less than 4 months) approval to Adapt Pharma for Narcan nasal spray, the first product manufactured specifically for intranasal delivery. Intranasal use eliminates the risk of contaminated needlesticks and provides first responders and caregivers an easier and less intrusive administration site than the injectable form. The FDA approval will likely bring with it increased awareness of opioid overdoses, which have reached an epidemic level in the U.S. Opioid overdose is now the leading cause of injury-related death, surpassing motor vehicle accident deaths. Hopefully, the easier administration provided by intranasal Narcan will lead to greater use within the community setting. 

Narcan nasal spray is approved for the emergency treatment of known or suspected opioid overdose, generally presenting as severe respiratory depression. The nasal spray requires no assembly and provides a 4 mg dose per spray which has been shown to reach similar, or higher, levels as intramuscular injection in about the same amount of time (2–3 minutes). It works similarly to other types of nasal sprays you might be familiar with, such as allergy or cold remedies. Similar to the injectable form, the nasal form of naloxone may require repeated doses and may result in opioid withdrawal symptoms (diarrhea, runny nose, goose bumps, sweating, yawning, body aches, irritability, cramps, and increased heart rate and blood pressure). 

This new product hit pharmacy shelves last month at a cost of $70 for a box of 2 nasal sprays; many insurers will likely provide coverage. We recommend that you discuss the possibility of opiate overdose with your substance-abusing patients, and educate them about the availability of rescue treatment and the importance of family members or friends having access to naloxone rescue. As we’ve said before, “Naloxone rescue saves lives. Prescribe it.”