Anti-overdose drug Naloxone may soon be available without a prescription

Naloxone, a drug used to reverse overdoses caused by opioid use, may soon be available without a prescription in the United States.

Harm Reduction Therapeutics, a nonprofit pharmaceutical company, has developed a nasal spray that releases naloxone, which its marked Live. The company announced on December 26 that the United States Food and Drug Administration expedite the approval process for RiVive so that it can be available over-the-counter at a low cost to everyone.

Naloxone, which works by binding to opioid receptors in the brain and reversing the effects of opioids, has long been a important harm reduction measure in the struggle to curb opiate epidemic in the United States and elsewhere.

The FDA itself, alongside public health experts, has long supported the availability of naloxone over-the-counter and is expected to complete its priority review by the end of April 2023.

An effective antidote to opioid overdoses

Naloxone was first approved in the United States in 1971. It is a highly effective drug, reversing nearly 99% of all opioid overdoses. But Iit’s so far available only by prescription in the United States, despite no significant risk of abuse or serious side effects. The drug can trigger opioid withdrawal symptoms, but its emergency use saves lives, and patients must be placed under the care of a health care provider thereafter.

It is recommended that friends and family of opioid users carry naloxone, as well as people who may live or work in areas where opioid abuse is common.

Experiences In other countries showed that the over-the-counter availability of naloxone can significantly reduce fatal overdoses, especially when combined with training in its administration and in recognizing the signs of an opioid overdose. A 2019 study found that if naloxone were widely available and affordable, fatal opioid overdoses could down more than 20%.

To facilitate access to the drug, most states (42, as well as Washington, D.C.) have made the drug available at pharmacies without a prescription through standing orders physicians, allowing pharmacists to dispense the drug without a prescription.

However, most pharmacists are unaware of this provision, making over-the-counter approval an essential next step in making the drug readily available nationwide.

RiVive will be inexpensive or free

Beyond its availability, ReVive will have another important advantage: its price. Naloxone is manufactured by Pfizer under the brand name Narcan, and its price ranges from around $60 for the injectable to $160 or more for the nasal spray. In 2021, shortages drives up prices even more, making it difficult for nonprofits to source Narcan.

RiVive should be much cheaper. The manufacturer, Harm Reduction Therapeutics, was founded in 2017 as a non-profit organization specifically with the goal of making the drug available cheap or free. So keeping its price as low as possible is core to its mission.

If the FDA approves the application, as expected, Harm Reduction Therapeutics said it plans to make RiVive available for purchase starting in 2024.