Other OTC Opioid Overdose Reversal Medication Approved by the FDA

The FDA has approved a second OTC opioid overdose reversal medication following the historic approval of Narcan (Emergent BioSolutions) non-prescription nasal spray in March 2023. RiVive (Harm Reduction Therapeutics) 3 mg naloxone hydrochloride nasal spray is now the second emergency treatment for known or suspected opioid overdose to obtain approval for non-prescription use.¹

“We know that naloxone is a powerful tool to quickly reverse the effects of opioids during an overdose. Ensuring that naloxone is widely available, especially as an approved OTC product, makes a critical tool available to help protect public health ,” said FDA Commissioner Robert M. Califf, MD, in a press release. “The agency has long prioritized access to naloxone products, and we welcome manufacturers of other naloxone products to discuss potential non-prescription development programs with FDA.”¹

The FDA approval of RiVive was supported by results from a study showing that similar levels of the drug are able to reach the bloodstream as an approved prescription naloxone product. RiVive has also been shown to be safe and effective when used as directed in the labeling. Further, the FDA said that Harm Reduction Therapeutics provided data showing that consumers can understand how to use RiVive safely and effectively without the supervision of a healthcare professional.

Use of RiVive Nasal Spray in individuals who are dependent on opioids may result in severe opioid withdrawal characterized by body aches, diarrhea, increased heart rate, fever, runny nose, sneezing, goosebumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shaking or trembling, stomach cramps, weakness and high blood pressure, according to the FDA.

High rates of opioid-related deaths are a major problem in the United States and were only exacerbated by the COVID-19 pandemic. CDC data shows that 107,000 Americans died of drug overdoses in 2021, more than 70,000 of which were the result of synthetic opioids containing fentanyl.²

Other research has found a 113% increase in “Years of Life Lost” (YLL) among adolescents and young adults in the United States due to accidental drug overdose. YLL is the difference between the age at which a person dies and their expected remaining life expectancy, according to researchers at Ohio State University Wexner Medical Center.²

Their study found that the number of youth YLL for accidental drug overdose more than doubled from 39,579 in 2019 to 84,179 in 2020 after being relatively stable between 2016 and 2019.² Synthetic opioids, including primarily illicitly produced fentanyl, contributed to 68,356 YLL compared to 26,628 in 2019. The YLL for accidental overdose in 2020 was also higher for males (59,274) than females (24,905).²

The cost of naloxone can vary depending on several factors, including formulation, dose, pharmacy, and location. Without insurance, the cost of a single dose of naloxone can range from approximately $120 to $150 or more, depending on the specific product and where it is purchased.³ It is critical to raise awareness among patients about how pharmacies can provide discounts and how those who cannot afford naloxone may be eligible for additional financial support.⁴

The timeline for availability and price of RiVive will be determined by the manufacturer, the FDA noted.

References

1. FDA approves second over-the-counter naloxone nasal spray product. FDA. News release. 28 July 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-second-over-counter-naloxone-nasal-spray-product?utm_medium=email&utm_source=govdelivery. Opened on July 28, 2023.

2. ‘Years of Life Lost’ Due to Accidental Drug Overdose in Teenagers Increase During Pandemic. News release. Ohio State University Wexner Medical Center. 13 September 2022. Accessed 28 July 2023. https://wexnermedical.osu.edu/mediaroom/pressreleaselisting/years-of-life-lost-to-unintentional-drug-overdose-in-adolescents-spikes-during-pandemic

3. Evoy KE, Hill LG, Davis CS. Considering the potential benefits of over-the-counter Naloxone. Integr Pharm Res Pract. 2021;10:13-21. Published 2021 Feb 15 doi:10.2147/IPRP.S244709. Opened on July 28, 2023.

4. Martinez C, et al. Changing the Game: Pharmacy Student Perspectives on Naloxone OTC Approval. Pharmacy Hours. Published April 23, 2023. Accessed July 28, 2023.