The FDA fast-tracked approval for the lifesaving drug
Naloxone, a drug that is used to reverse overdoses caused by opioid use, might soon be available without a prescription in the US.
Harm Reduction Therapeutics, a nonprofit pharmaceutical company, has developed a nasal spray that delivers naloxone, which it branded RiVive. The company announced on Dec. 26 that the US Food and Drug Administration is fast-tracking the approval process for RiVive so that it can be available over the counter at low cost to anyone.
Naloxone, which works by binding itself to opioid receptors in the brain and reversing the effects of opioids, has long been an important harm reduction measure in the fight to curb the opioid epidemic in the US and elsewhere.
The FDA itself, alongside public health experts, has long supported over-the-counter availability of naloxone, and is expected to complete its priority review by late April 2023.
An effective antidote to opioid overdoses
Naloxone was first approved in the US in 1971. It’s a highly effective drug, reversing nearly 99% of all opioid overdoses. But it is so far only available with prescription in the US, despite no significant risk of misuse or severe side effects. The drug can trigger opioid withdrawal symptoms, but its emergency use is life-saving, and patients should be put under the care of a healthcare provider afterward.
It is recommended that friends and family of opioid users carry naloxone with them, as well as people who may live or work in areas where opioid misuse is frequent.
Experiments in other countries have shown that over-the-counter availability of naloxone can drastically reduce deadly overdoses, particularly when coupled with training in its administration and in recognizing the signs of an opioid overdose. A 2019 study found that if naloxone was made available widely and affordably, fatal opioid overdoses could go down by more than 20%.
To make access to the drug easier, most states (42, as well as Washington, DC) have made the drug available in pharmacies without a prescription through standing orders from physicians, allowing pharmacists to provide the drug without prescription.
However, most pharmacists are unaware of this provision, making the over-the-counter approval an essential next step in making the drug easily available across the country.
RiVive will be low-cost, or free
Beyond its availability, ReVive will have another important advantage: its price tag. Naloxone is manufactured by Pfizer under the brand name Narcan, and its price ranges from about $60 as an injectable to $160 or more for the nasal spray. In 2021, shortages drove up prices even further, making it difficult for nonprofits to procure Narcan.
RiVive is expected to be much cheaper. The maker, Harm Reduction Therapeutics, was founded in 2017 as a nonprofit specifically with the goal of making the drug available at low-cost or free. So keeping its price as low as possible is core to its mission.
Should the FDA approve the application, as is expected, Harm Reduction Therapeutics said it plans to make RiVive available for purchase starting in 2024.
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