FDA Approves First OTC Naloxone Nasal Spray For Opioid Overdose

 

• The FDA has approved Emergent BioSolutions Inc's 
  EBS+5.73%+ Free Alerts
   Narcan, 4 milligrams (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription use – the first naloxone product approved for use without a prescription. 
• Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose. 
• The move paves the way for the medication to reverse an opioid overdose to be sold directly to consumers in drug stores, convenience stores, grocery stores, gas stations, and online stores.
• The FDA will work to help facilitate the continued availability of naloxone nasal spray products during the time needed to implement the Narcan switch from prescription to OTC status, which may take months. 
• Other formulations and dosages of naloxone will remain available by prescription only.
• The drug overdose deaths from synthetic opioids like fentanyl have increased 7.5-fold from 2015 to 2021, the most significant percentage of overall drug-involved overdose deaths in the U.S. 
• In November, the FDA issued a notice regarding the safety and effectiveness of certain naloxone hydrochloride products for OTC use.
• The White House announced $1.5 billion in funding to tackle opioid overdoses, sanctions against traffickers, and increased funding for law enforcement.

https://www.benzinga.com/general/biotech/23/03/31548384/fda-approves-first-otc-naloxone-nasal-spray-for-opioid-overdose