FDA Approves Second OTC Naloxone Spray, ReVive, for Suspected Opioid Overdose
Medically reviewed by Drugs.com.
By Lori Solomon HealthDay Reporter
THURSDAY, Aug. 3, 2023 -- The U.S. Food and Drug Administration has approved RiVive, an over-the-counter (OTC) naloxone hydrochloride nasal spray for emergency treatment of known or suspected opioid overdose.
"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," FDA Commissioner Robert M. Califf, M.D., said in an agency news 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."
The approval was based on data that showed similar levels of RiVive reach the bloodstream as an approved prescription naloxone product. Additionally, the drug was shown to be safe and effective. Finally, the manufacturer also showed that consumers can understand how to use the drug safely and effectively without the supervision of a health care professional.
"Every step taken to increase the availability of safe and effective opioid-related overdose-reversal medications will save lives," Bobby Mukkamala, M.D., chair of the American Medical Association Substance Use and Pain Care Task Force, said in a statement. "There is no medical or ethical reason for naloxone manufacturers to delay submitting these applications."
The FDA previously approved the first nonprescription naloxone nasal spray product in March 2023 and the first generic nonprescription naloxone nasal spray product in July 2023.
Approval of RiVive was granted to Harm Reduction Therapeutics.
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2024 HealthDay. All rights reserved.
Posted August 2023
Read this next
Just a Few Surgeries Make Up Most Post-Op Opioid Prescriptions
WEDNESDAY, July 3, 2024 -- Opioid addiction often starts with a prescription for post-surgery pain relief, and two new studies identify a handful of procedures that account for...
Most Americans Don't Know That Family Doctors Can Prescribe Anti-Opioid Meds
TUESDAY, July 2, 2024 -- Most people addicted to opioids and their loved ones are unaware that their primary care doctor can prescribe a medication to treat the disorder, a new...
All Diamond Shruumz Edibles Recalled Over High Levels of Mushroom Toxin in Products
MONDAY, July 1, 2024 -- All Diamond Shruumz edibles have been recalled after the company found high levels of a mushroom toxin in them that may have sickened 39 people in 20...
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.
