Second OTC Opioid Overdose Reversal Medication Approved by FDA

The FDA has approved another OTC opioid overdose reversal medication following the historic approval of Narcan (Emergent BioSolutions) nasal spray for nonprescription use 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 gain approval for nonprescription use.¹

“We know naloxone is a powerful tool to help quickly reverse the effects of opioids during an overdose. Ensuring 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 nonprescription development programs with the FDA.”¹

The FDA approval of RiVive was supported by findings from a study that demonstrated similar levels of the drug are able to reach the bloodstream as an approved prescription naloxone product. RiVive was also shown to be safe and effective for use as directed in its 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 health care professional.

RiVive nasal spray use in those dependent on opioids may result in severe opioid withdrawal characterized by body aches, diarrhea, increased heart rate, fever, runny nose, sneezing, goose bumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure, according to the FDA.

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

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

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

The cost of naloxone can vary depending on several factors, including the formulation, dose, pharmacy, and location. Without insurance, the price for 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 crucial to bring awareness to patients about how pharmacies can provide discounts, and how those who cannot afford naloxone may be eligible for further financial aid.⁴

The timeline for availability and the 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. July 28, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-second-over-counter-naloxone-nasal-spray-product?utm_medium=email&utm_source=govdelivery. Accessed July 28, 2023.

2. ‘Years of Life Lost’ to unintentional drug overdose in adolescents spikes during pandemic. News release. Ohio State University Wexner Medical Center. September 13, 2022. Accessed July 28, 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. Accessed July 28, 2023.

4. Martinez C, et al. Changing the Game: Pharmacy Students' Perspective on Naloxone OTC Approval. Pharmacy Times. https://www.pharmacytimes.com/view/changing-the-game-pharmacy-students-perspective-on-naloxone-otc-approval. Published April 23, 2023. Accessed July 28, 2023.