Why 3 mg of Naloxone?

Naloxone works by blocking opioid receptors in the brain, which allows the body to restore its own breathing once it is no longer able to receive the effects of opioids. At times, breathing may need to be aided by rescue breathing techniques administered by bystanders to an overdose, or emergency medical services personnel who arrive at the scene of an overdose, after naloxone is administered.

RiVive® uses 3.0 mg of naloxone to reverse opioid overdoses, including fentanyl overdoses. Our 3.0 mg dose is based on the scientific literature supporting the efficacy of naloxone in opioid overdose reversals broadly¹, and the efficacy of both 2.0 mg² and 4.0 mg intranasal (IN) naloxone formulations³.

Our decision to formulate RiVive with 3.0 mg of naloxone was based on extensive input from harm reduction experts, the long history of reversing opioid overdoses using 0.4 mg of intramuscular naloxone, and the desire to administer enough naloxone to restore spontaneous breathing⁴ without inducing full-blown acute opioid withdrawal.

Low dose naloxone has less of a chance of causing problematic, precipitated withdrawal that can complicate the overdose reversal and potentially cause harm to the person who has overdosed, just as they are recovering from a near death experience.

Although 2 mg naloxone nasal sprays are widely used in Europe, RiVive’s 3 mg is the lowest OTC dose of nasal spray naloxone available in the United States.

Citations:

For the scientific, regulatory, and public health rationale for 3 mg, click here.

To learn more about why the increasingly powerful opioid antagonists are not necessary, click here.

¹Wheeler, E., Jones, T.S., Gilbert, M.K., & Davidson, P.J. (2015). Opioid Overdose Prevention Programs Providing Naloxone to Laypersons — United States, 2014. Morbidity and Mortality Weekly Report, 64, 631 – 635.

²McDonald, R., Lorch, U., Woodward, J., Bosse, B., Dooner, H., Mundin, G., Smith, K.J., & Strang, J. (2017). Pharmacokinetics of concentrated naloxone nasal spray for opioid overdose reversal: Phase I healthy volunteer study*. Addiction (Abingdon, England), 113, 484 – 493.

³Avetian, G.K., Fiuty, P., Mazzella, S., Koppa, D., Heye, V., & Hebbar, P. (2018). Use of naloxone nasal spray 4 mg in the community setting: a survey of use by community organizations. Current Medical Research and Opinion, 34, 573 – 576.

⁴https://www.samhsa.gov/resource/ebp/opioid-overdose-prevention-toolkit