The Food and Drug Administration (FDA) on Friday approved an opioid overdose drug for over-the-counter (OTC) use from a nonprofit company.
The FDA has granted approval to RiVive, manufactured by Harm Reduction Therapeutics, making it the second OTC naloxone product authorized this year.
Naloxone is a lifesaving medication that plays a crucial role in reducing opioid overdose deaths. When administered promptly, typically within minutes of detecting the initial signs of an opioid overdose, naloxone can effectively counteract the overdose effects.
FDA Commissioner Dr. Robert M. Califf said that naloxone is a “powerful tool” for countering opioid overdoses.
Harm Reduction Therapeutics said the approval is a significant step in fulfilling its mission to prevent opioid overdose deaths by providing free or low-cost over-the-counter naloxone to people all over the United States.
Delivered as a nasal spray, it contains 3 milligrams (mg) of naloxone hydrochloride. Its approval aims to enhance consumer access to naloxone without the need for a prescription and at a low cost, given the nonprofit status of the company.
The company cautions that after using this product, some individuals might experience symptoms upon waking up, such as shaking, sweating, nausea, or feelings of anger.
RiVive is anticipated to be available in early 2024, at a lower price, primarily to harm-reduction organizations and state governments. The nonprofit plans to offer at least 200,000 free doses, constituting 10 percent of the initial annual production, to communities in need.
Notably, Harm Reduction Therapeutics will offer RiVive either for free or at a minimal break-even cost, estimated to be around $18. This approach contrasts with other naloxone products in the market.
The most widely used naloxone product, Narcan, received FDA approval for over-the-counter use in March. However, its cost remains a significant obstacle, with a two-pack of the prescription version ranging from $130 to $150 at various retailers.
Even at a discounted price of approximately $50, affordability can still be a barrier for many individuals.
Drug overdose remains a significant public health issue in the United States, with over 105,000 fatal overdoses reported in the 12 months ending in February, largely due to synthetic opioids like illicit fentanyl. Naloxone is a crucial medication that swiftly reverses opioid overdose effects and is the standard treatment.
The approval of RiVive as an OTC naloxone product was based on the manufacturer’s data, showing similar levels of RiVive in the bloodstream compared to an approved prescription naloxone product. The drug’s safety and effectiveness were demonstrated when used as directed without health care professional supervision.
However, the FDA noted that RiVive nasal spray may cause severe opioid withdrawal symptoms in individuals dependent on opioids.
To address the overdose crisis and reduce unnecessary opioid exposure, the FDA has been working on expanding access to opioid overdose reversal products.
The FDA has also focused on providing opioid disposal options to prevent nonmedical use and accidental exposure.
Harm Reduction Therapeutics emphasized that there will be no profits made from sales of RiVive. As a nonprofit, the company is actively seeking additional funding partners to expand accessibility and make their affordable opioid overdose treatment more widely available.
