Narcan may soon be available over-the-counter

Emergent BioSolutions, a drug company that manufactures naloxone is seeking approval from the Food and Drug Administration to sell the drug over the counter.

Narcan, a nasal spray version of naloxone, has a strong record of reversing deadly opioid overdoses, according to the company.

It is commonly used by emergency medical personnel and other first responders to revive individuals who overdose on drugs such as pain relievers, heroin, and fentanyl.

“Emergent is committed to increasing access and awareness of naloxone, said Robert Kramer, president and CEO of Emergent BioSolutions in a press release. “We are taking this step to help address the rising and devastating number of opioid overdoses and fatalities happening across the country.”

The medication’s popularity has grown in recent years as the increase in fentanyl users rises in the United States.

As of December 12, Ohio emergency medical service providers have administered naloxone to over 35,000 patients this year, according to Ohio Emergency Medical Services.

“Naloxone is a critical tool in combatting the addiction crisis and making our communities safer for all Ohioans,” said Eric Wandersleben, director of media relations for the Ohio Department of Mental Health.

Often when a person experiencing an overdose is reached by emergency services, it is too late to save them, according to the National Institute on Drug Abuse.

In Ohio, more than 5,200 people died of drug overdoses in 2020, according to data from the Centers for Disease Control and Prevention (CDC). That year, the state’s mortality rate was the fourth highest in the nation when more than 47 people per 100,000 died of drug overdoses.

In Portage County alone, overdose deaths rose by 33%, from 33 deaths in 2019 to 44 deaths in 2020, according to the Mental Health Recovery Board of Portage County.

During a December press conference, Dr. Rahul Gupta, director of the White House Office of National Drug Control Policy, said roughly 80,000 Americans died from opioid overdoses in the past 12 months.

Gupta said many of those deaths could have been prevented with naloxone.

“There is today no excuse, no excuse absolutely for not having it everywhere available, when we know that’s one medication that can save tens of thousands of lives right now,” Gupta said.

Currently, the medication is hard to get because of varying federal and state laws. However, In Ohio, naloxone is already available through several community partners.

In 2021, Ohio’s Department of Mental Health and Addiction Services distributed more than 200,000 units of the drug throughout the community, including emergency response agencies, local health departments and Project DAWN sites.

Project DAWN programs distribute naloxone and provide training at several sites and locations to prevent opioid overdose and promote harm reduction. It was created in partnership with the Ohio Department of Health to bring awareness to overdose reversal medication.

Project DAWN is one of many ways Ohio citizens can get access to Narcan.

The department’s goal is to increase the number of units distributed within the next 12 months.

“OhioMHAS will be financing $9 million worth of naloxone and naloxone-related activities,” said Wandersleben. “We are committed to making quality, cost-effective prevention, treatment, recovery and harm reduction services more visible, accessible, and effective for all Ohioans.”

The FDA granted an expedited review for over-the-counter Narcan.

This priority review means the FDA aims to evaluate the submission on the shortened timeline of six months as opposed to the usual 10 months for a typical review. If approved, it would be the first-ever over-the-counter naloxone to go on the market.

Emergent’s submission to the FDA includes Human Factors studies, as well as more than five years of post-marketing data to demonstrate the safe and effective use of NARCAN, according to a company press release.

Emergent says it expects to receive approval by the end of March.

Narcan may soon be available over the counter in the United States. Emergent BioSolutions, a drug company that manufactures naloxone is seeking approval from the Food and Drug Administration to sell the drug over the counter. pic.twitter.com/jMir4CcwqS

— Joshua Bailey (@JoshuaBaileyTV) December 16, 2022