FDA May Drop Naloxone Prescription Rule


Food and Drug Administration | Image by Tada Images/Shutterstock

In the midst of a nationwide opioid epidemic, one federal agency is fast-tracking approval for an over-the-counter medication capable of saving someone’s life during an overdose.

The non-profit pharmaceutical company Harm Reduction Therapeutics Inc. (HRT) has been granted a priority review from the Food and Drug Administration (FDA) to produce its overdose-reversal drug without a prescription.

The relatively inexpensive drug RiVive is a nasal spray that delivers a three-milligram dose of naloxone to temporarily reverse the effects of opioid overdose. When tested on 36 participants, the nasal spray formula resulted in triple the concentration of naloxone in their blood compared to when the drug was administered as a shot.

The FDA is expected to decide on removing the prescription requirement for RiVive by April 28, 2023.

Texas, like other states, continues to deal with the growing challenge of overdoses attributed to the opioid fentanyl. Texas has even implemented a statewide campaign: “one pill can kill.”

Dallas has experienced dozens of accidental fentanyl overdoses in recent years. In 2021, the Dallas Police Department Special Investigation Division seized over 4,400 grams of fentanyl in a dozen operations, leading to multiple arrests.

In early December, fentanyl made national headlines yet again when a toddler playing in a park in San Francisco suffered an accidental overdose. Had paramedics not arrived quickly enough with a dose of naloxone, authorities say the child likely would have died.

HRT intends to produce two million doses of its nasal spray annually, of which 10% will be given away. The remainder would be sold at $18 a dose to pharmacies like CVS and Walgreens and public-sector organizations that help drug users.

Michael R. Hufford, the company’s CEO and co-founder, says the company is focused on “[c]ost and access.”

HRT is not the first company to develop a naloxone nasal spray. Emergent BioSolutions Inc., which produces the Narcan brand nasal spray, is similarly awaiting FDA approval to change the status of its overdose drug to over-the-counter. Narcan can cost upwards of $100 for a two-dose prescription without insurance.

Pocket Naloxone Corp. is yet another pharmaceutical company developing a nasal product. Instead of a spray, Pocket Naloxone produces a swab version.

According to the company, the nasal-swab style can be made at a lower cost than a spray alternative. Pocket Naloxone has submitted results to the FDA to show the efficacy of its delivery system, claiming it is faster-acting than existing prescription varieties.

Five years ago, Hufford and John Pinney decided to found HRT after attending a session where the FDA encouraged drugmakers to apply for over-the-counter approval for overdose-reversal medication.

Interestingly, Hufford obtained funding at the time from the drugmaker Purdue Pharma, maker of OxyContin. Earlier in 2022, Purdue reached a settlement to pay out $6 billion related to its apparent role in driving the opioid epidemic in the United States.

According to HRT, the company continues to receive funds from bankruptcy proceedings against Purdue. However, HRT also stated that Purdue would not be entitled to any royalties from the sale of RiVive, nor does Purdue have discretion over how and where the overdose drug is marketed.

Texans can find more information about accessing naloxone here.

If you enjoyed this article, please support us today!

Formed in 2021, we provide fact-based, non-partisan news. The Dallas Express is a non-profit organization funded by charitable support and advertising.

Please join us on the important journey to make Dallas a better place!

We welcome and appreciate comments on The Dallas Express as part of a healthy dialogue. We do ask that you be kind. Kind to each other and to everyone else in your comments. For more information, please refer to our Complete Comment Moderation Policy.

Subscribe to Comments
Notify of

Newest Most Voted
Inline Feedbacks
View all comments
Dick Smith
Dick Smith
1 month ago

They should just legalize it all and end the cartels

1 month ago

Oh what a tangled web we weave…. Just like Covid it’s all about the Benjamin’s. Trust factors: Government- 0%, Church- 0%, Medical profession -2%, self-50%, GOD- 100%