On July 28, 2023, the U.S. Food and Drug Administration (FDA) approved Harm Reduction Therapeutics RiVive™ (naloxone) nasal spray 3 mg for over-the-counter (OTC), nonprescription, use. Naloxone rapidly reverses the adverse effects of opioid analgesics in an overdose.

RiVive is the first naloxone product approved in a 3 mg strength and the third naloxone product to be approved for OTC use. Harm Reduction Therapeutics plans to launch RiVive by early 2024 — primarily to U.S. harm reduction organizations and state governments.

As we previously discussed on our blog, Emergent BioSolutions Inc. plans to launch its OTC version of Narcan® (naloxone) nasal spray 4 mg in late summer. Additionally, Padagis® received FDA approval for a change from prescription to OTC for their generic naloxone nasal spray 4 mg.

Click here to learn more about naloxone and its impact on the Optum Workers’ Compensation, Auto No-Fault, and Settlement Solutions.

If you have any questions, please contact your account manager, clinical liaison, or the Optum Clinical Services team at 1-877-275-7674 ext. 8612.

Sources:

1.        FDA News Release, July 28, 2023. FDA Approves Second Over-the-Counter Naloxone Nasal Spray Product. Accessed on August 2, 2023.

2.        Harm Reduction Therapeutics. Available at: https://www.harmreductiontherapeutics.org/. Accessed on August 3, 2023.