FDA Approves Second Over-the-Counter Naloxone Nasal Spray
The FDA has given its approval for a 2nd Over-the-Counter/OTC naloxone nasal spray. Naloxone is an opioid antagonist used to rapidly reverse an opioid overdose.
Naloxone is a critical drug used to reverse opioid overdoses and has been available primarily by prescription since 2015 or through emergency responders. The FDA's decision to approve a second OTC naloxone nasal spray represents a significant step in increasing access to this vital medication, empowering individuals and caregivers to respond promptly to opioid-related emergencies.
“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,” said FDA Commissioner Robert M. Califf, M.D.
Opioid overdoses continue to be a significant public health concern in the United States, with devastating consequences for individuals and families. According to the FDA, In the 12-month period ending in February 2023, more than 105,000 reported fatal overdoses occurred which were primarily driven by synthetic opioids such as fentanyl. The FDA's approval of the OTC naloxone nasal sprays offers renewed hope in reducing the toll of opioid-related deaths.
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