Intranasal naloxone has potential to be first in US to treat opioid overdose

FDA has granted priority review to naloxone nasal spray (Indivior) for the treatment of opioid overdose. If approved, naloxone nasal spray is expected to be the first FDA-approved intranasal naloxone product indicated to treat opioid overdose in the United States.

Related: Naloxone dispensing, education for pharmacists available in new guide from CPNP

Naloxone nasal spray is designed to deliver naloxone through the nasal mucosa of an overdose victim. The drug comes as a pre-filled device that contains naloxone specially formulated for optimal absorption into the nasal mucosa. The device has been designed to require minimal training so individuals may be better equipped to help an opioid overdose victim.

“Naloxone is the standard treatment for an opioid overdose,” according to Shaun Thaxter, chief executive officer of Indivior. “Naloxone works as an opioid receptor antagonist that effectively binds to the opioid receptors in the brain and reverses the effects of natural and synthetic opioids. Currently, only needle-based formulations of naloxone are FDA-approved for emergency medical professionals. However, [this] naloxone nasal spray is designed to enable anyone-be they layperson, trained healthcare personnel or first responders-to administer treatment at the scene of an overdose.

In April 2014, FDA approved Evzio (naloxone hydrochloride injection, Kaléo) that can be used by family members or caregivers to treat a person known or suspected to have had an opioid overdose. The drug rapidly delivers a single dose of the drug naloxone via a hand-held auto-injector that can be carried in a pocket or stored in a medicine cabinet. It is intended for the emergency treatment of known or suspected opioid overdose, characterized by decreased breathing or heart rates, or loss of consciousness.

Related: [BLOG]: Use and abuse of opioids: FDA responds

There are 3 take-aways formulary managers need to remember when it comes to naloxone, according to Thaxter:

• Naloxone is the standard treatment for an opioid overdose.

• Currently, only needle-based formulations of naloxone are FDA-approved for emergency medical professionals.

• According to FDA, the lack of a lay-friendly delivery system has made it difficult to make naloxone more broadly available to the public.

As drug abuse has reached epidemic proportions in the United States, formulary managers should be aware of the following 3 issues:

• According to the National Institute on Drug Abuse (NIDA), the total number of US overdose deaths involving opioid pain relievers from 2001 to 2013 has increased 4-fold. In 2013 alone, 37% of drug overdose deaths were associated with prescription opioid analgesics.

• Opioid and heroin overdoses cause more than 25,000 deaths in the United States every year.

• Between 50% to 80% of patients who died from a prescription opioid overdose had a history of chronic pain.

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