RiVive FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 1, 2023.
FDA Approved: Yes (First approved July 28, 2023)
Brand name: RiVive
Generic name: naloxone hydrochloride
Dosage form: Nasal Spray
Company: Harm Reduction Therapeutics, Inc.
Treatment for: Opioid Overdose
RiVive (naloxone hydrochloride) is an over-the-counter (OTC) opioid antagonist nasal spray indicated for the emergency treatment of opioid overdose.
- Overdose deaths remain a leading cause of injury-related death in the United States. The majority of overdose deaths involve opioid drugs, which include the illegal drug heroin, synthetic opioids such as fentanyl, and prescription pain relievers such as oxycodone (OxyContin), hydrocodone, codeine, and morphine.
- Naloxone is an opioid antagonist that has been used for decades to safely and effectively reverse opioid overdoses. Naloxone works to reverse an opioid overdose by competing for the mu, kappa and sigma opiate receptor sites in the CNS to block the effects of opioids. Naloxone can restore normal breathing within 2 to 3 minutes in a person whose breathing has slowed or stopped as a result of opioid overdose.
- Naloxone is approved in injectable and intranasal formulations including injection (Narcan Injection (discontinued), Evzio (discontinued), Zimhi), prescription nasal spray (Kloxxado), and over-the-counter nasal spray (Narcan Nasal Spray, RiVive).
- RiVive is the second naloxone nasal spray FDA approved for over-the-counter use for the emergency treatment of opioid overdose. Narcan Nasal Spray was the first naloxone nasal spray approved for OTC use in March 2023. RiVive contains naloxone hydrochloride 3.0 mg delivered in a single spray, while Narcan Nasal Spray contains 4.0 mg.
- RiVive is administered as a single spray into the nose. RiVive is supplied in twin packs containing two single-dose devices. If a person who has overdosed on opioids does not wake up 2-3 minutes after the first dose of RiVive, a second dose can be administered. It is safe to keep administering RiVive every two to three minutes until the person wakes up.
- RiVive is manufactured by Harm Reduction Therapeutics (HRT), Inc., a nonprofit pharmaceutical company founded in 2017 in response to the severe price and access limits to existing naloxone products. HRT is focused on supplying RiVive to communities who need it most and will make at least 200,000 doses (10% of projected initial annual product production) available for free.
Development timeline for RiVive
Further information
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