Donate to Science & Enterprise

S&E on Mastodon

S&E on LinkedIn

S&E on Flipboard

Please share Science & Enterprise

Over-the-Counter Naloxone Receiving Faster FDA Review

Nasal spray


28 Dec. 2022. The opioid overdose drug naloxone in nasal spray form is receiving priority review from the Food and Drug Administration as an over-the-counter drug. Harm Reduction Therapeutics Inc. in Bethesda, Maryland, developer of the naloxone nasal spray branded as RiVive, says FDA accepted the group’s new drug application for regulatory approval, as well as assigned it a priority review to speed the process.

Centers for Disease Control and Prevention says in 2021, the U.S. experienced more than 107,600 drug overdose deaths, a 15 percent increase over 2020, with two-thirds of those deaths (66%) from the synthetic opioid fentanyl. In mid-November, FDA issued an early assessment that encourages non-prescription naloxone to combat the continuing problem of opioid overdose cases and deaths. FDA notes that naloxone can help reduce deaths when administered within a few minutes of overdose symptoms occurring, adding that certain naloxone products such as nasal sprays or auto-injector pens could be approved for non-prescription use.

Harm Reduction Therapeutics is a not-for-profit organization formed in 2017 to develop low-price and freely available naloxone to prevent opioid overdose deaths. Naloxone is an opioid antagonist that binds to nerve cell receptors, much like opioids, but instead blocks and reverses the effects of opioids, to enable breathing in people with an overdose. Harm Reduction Therapeutics notes that naloxone was first approved by FDA in 1971 and has been a standard part of emergency medicine since then. The organization’s goal is to make naloxone readily available at little or no cost to friends or family members of people addicted to opioids.

Equivalent bio-activity as intramuscular injections

The first product from Harm Reduction Therapeutics is a single-use nasal spray called RiVive that gives three milligrams of naloxone in a dose. The group tested the nasal spray, then code-named HRT001, in a early-stage clinical trial with 36 healthy volunteers. Harm Reduction Therapeutics released results of the trial in March 2022, which are not yet peer reviewed. The organization says findings show participants received as much naloxone in their blood from HRT001 nasal sprays as received from intramuscular injections, at both 2.5 and 5 minutes following administration.

Harm Reduction Therapeutics says FDA accepted its new drug application and granted priority review to RiVive as an over-the-counter or OTC drug. FDA assigns a priority review “for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.” With priority review, regulatory approval can be given in six instead of the usual 10 months, and the organization expects to hear from FDA about a decision by the end of April 2023.

“When we formed Harm Reduction Therapeutics in 2017,” says co-founder and CEO Michael Hufford in an organization statement released through Cision, “we saw the urgent need to develop an OTC naloxone product, an action that no other company had pursued.” Hufford adds that “the public health landscape is beginning to evolve, with OTC naloxone hopefully set to become a reality.”

More from Science & Enterprise:

We designed Science & Enterprise for busy readers including investors, researchers, entrepreneurs, and students. Except for a narrow cookies and privacy strip for first-time visitors, we have no pop-ups blocking the entire page, nor distracting animated GIF graphics. If you want to subscribe for daily email alerts, you can do that here, or find the link in the upper left-hand corner of the desktop page. The site is free, with no paywall. But, of course, donations are gratefully accepted.

*     *     *


Comments are closed.