Naloxone Startup Pursues FDA Approval for Over-the-Counter Swab

The FDA has encouraged pharmaceutical companies to apply for approval for over-the-counter versions of the drug to help confront a swelling overdose crisis from bootleg versions of the powerful opioid fentanyl. Pocket Naloxone said it plans to apply for new drug approval in the first half of 2023 and to request priority review.

In November, the FDA told prescription-drug makers that once it has sufficient data to support approval of a nonprescription naloxone product, any naloxone products marketed as prescription-only without clinically meaningful difference from nonprescription products will be considered misbranded.

“We are committed to making it affordable and conveniently purchasable in retail stores and online as an over-the-counter product, said Ashanthi Mathai, Pocket Naloxone’s chief executive.

An FDA spokeswoman said the agency hopes the notice will increase applications from drugmakers. She said the notice wasn’t a final determination of safety and efficacy, nor a mandate to make naloxone available over-the-counter immediately.

The agency previously created a label explaining how to use naloxone that a company could base their own label on when applying for over-the-counter approval.

A spokeswoman for the White House’s Office of National Drug Control Policy said the FDA’s decision-making process is independent but that the White House also wants to see naloxone available widely.

Narcan, the prescription-only nasal spray version of the drug approved in 2015 and owned by

Emergent BioSolutions Inc.,

and its slightly cheaper generic competitors have become the most popular versions of the drug to dispense to laypeople and first responders.

Sales of Narcan nasal spray rose to $224 million in 2020, or 78% of naloxone sales in dollar terms, from 15% or $56 million in 2017, according to

IQVIA Holdings Inc.,

which collects drug sales data. Those doses made up about 48% of naloxone kits in 2020, up from 21% in 2017.

Widely available and significantly cheaper intramuscular naloxone has been less popular in the public sector because it requires using a needle. No companies producing the nasal-spray drug or its intramuscular counterpart have sought to make the drugs available over-the-counter despite several years of prodding by the FDA.

Advocacy groups say the situation is making it difficult for people to easily access cheap and easy-to-use naloxone in an emergency. Out-of-pocket costs for uninsured patients seeking naloxone rose 506% between 2014 and 2018, according to a study published this year in JAMA Health Forum.

This year two new companies said they were planning applications to the FDA to produce over-the-counter overdose reversal medications. Pocket Naloxone and Harm Reduction Therapeutics Inc., a nonprofit with funding from now-bankrupt Purdue Pharma LP, both say they aim to make the drug cheap and widely available.

—Liz Essley Whyte contributed to this article.

Write to Julie Wernau at [email protected]

The FDA has encouraged pharmaceutical companies to apply for approval for over-the-counter versions of the drug to help confront a swelling overdose crisis from bootleg versions of the powerful opioid fentanyl. Pocket Naloxone said it plans to apply for new drug approval in the first half of 2023 and to request priority review.

In November, the FDA told prescription-drug makers that once it has sufficient data to support approval of a nonprescription naloxone product, any naloxone products marketed as prescription-only without clinically meaningful difference from nonprescription products will be considered misbranded.

“We are committed to making it affordable and conveniently purchasable in retail stores and online as an over-the-counter product, said Ashanthi Mathai, Pocket Naloxone’s chief executive.

An FDA spokeswoman said the agency hopes the notice will increase applications from drugmakers. She said the notice wasn’t a final determination of safety and efficacy, nor a mandate to make naloxone available over-the-counter immediately.

The agency previously created a label explaining how to use naloxone that a company could base their own label on when applying for over-the-counter approval.

A spokeswoman for the White House’s Office of National Drug Control Policy said the FDA’s decision-making process is independent but that the White House also wants to see naloxone available widely.

Narcan, the prescription-only nasal spray version of the drug approved in 2015 and owned by

Emergent BioSolutions Inc.,

and its slightly cheaper generic competitors have become the most popular versions of the drug to dispense to laypeople and first responders.

Sales of Narcan nasal spray rose to $224 million in 2020, or 78% of naloxone sales in dollar terms, from 15% or $56 million in 2017, according to

IQVIA Holdings Inc.,

which collects drug sales data. Those doses made up about 48% of naloxone kits in 2020, up from 21% in 2017.

Widely available and significantly cheaper intramuscular naloxone has been less popular in the public sector because it requires using a needle. No companies producing the nasal-spray drug or its intramuscular counterpart have sought to make the drugs available over-the-counter despite several years of prodding by the FDA.

Advocacy groups say the situation is making it difficult for people to easily access cheap and easy-to-use naloxone in an emergency. Out-of-pocket costs for uninsured patients seeking naloxone rose 506% between 2014 and 2018, according to a study published this year in JAMA Health Forum.

This year two new companies said they were planning applications to the FDA to produce over-the-counter overdose reversal medications. Pocket Naloxone and Harm Reduction Therapeutics Inc., a nonprofit with funding from now-bankrupt Purdue Pharma LP, both say they aim to make the drug cheap and widely available.

—Liz Essley Whyte contributed to this article.

Write to Julie Wernau at [email protected]