The Food and Drug Administration (FDA) has recently granted approval for the first over-the-counter (OTC) version of naloxone from a nonprofit organization called Harm Reduction Therapeutics. This initiative seeks to provide affordable and potentially free doses of the opioid overdose drug to those Americans who are in dire need of it.
RiVive, the newly approved naloxone product, marks the second OTC naloxone product approved by the FDA this year. Naloxone is a medication that can significantly reduce opioid overdose deaths. When administered promptly, usually within minutes of the initial signs of an overdose, naloxone effectively counteracts the overdose effects. The person usually regains consciousness within one to three minutes, though repeat administration may be necessary.
Each RiVive device contains a single dose of naloxone and will be available exclusively in twin packs, with each pack containing two devices, each carrying a 3 milligram dose. The company anticipates that RiVive will be released in the early months of 2024, primarily targeting harm reduction organizations and state governments. The cost of RiVive is expected to be lower compared to other opioid antagonist nasal sprays.
Michael Hufford, co-founder and CEO of Harm Reduction Therapeutics, expressed gratitude for the FDA approval of RiVive. He stated that this milestone would allow their organization to bring a lower-cost nasal naloxone product to the market without a prescription, with the intention of saving lives that would otherwise be lost to opioid overdose. Unlike other naloxone products, Harm Reduction Therapeutics plans to provide RiVive for free or at a low break-even cost.
As part of their commitment to supply communities in greatest need, Harm Reduction Therapeutics plans to distribute at least 200,000 doses of RiVive for free, which amounts to 10% of their projected initial annual production. The nonprofit emphasized that no entity or individual will profit from the sales of RiVive. This is a notable departure from the more expensive prescription versions of naloxone, such as Narcan, which can cost around $130 to $150 for a two-pack. Even with discounts, price remains a significant barrier.
The FDA has been actively encouraging drug companies to seek approval for over-the-counter naloxone products to increase accessibility. However, only two companies successfully applied for and received fast-track priority review – Emergent and Harm Reduction Therapeutics. FDA Commissioner Robert Califf encourages other manufacturers to collaborate with the agency on developing OTC naloxone products to protect public health.
In conclusion, the newly approved OTC naloxone from Harm Reduction Therapeutics is a significant step towards addressing the opioid crisis and increasing accessibility to life-saving medications. The availability of RiVive in early 2024 will provide a more affordable alternative to current naloxone products, potentially saving more lives.
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