Opioid reversal agent naloxone approvable for OTC use – FDA

Sarah Silbiger

• The U.S. Food and Drug Administration (FDA) announced Tuesday that certain forms of opioid reversal therapy, naloxone, could be safe and effective for over-the-counter use, potentially opening the door for its switch to nonprescription status.
• The notice includes a preliminary assessment that some naloxone products, up to 4mg nasal spray and 2mg autoinjector, could be approvable for OTC use, the agency said.
• Naloxone is a prescription drug used in the U.S. to treat opioid overdose. Leading manufacturers of naloxone include Pfizer (NYSE:PFE), Emergent BioSolutions (EBS), Teva Pharmaceutical (TEVA), Opiant Pharmaceuticals (OPNT), Hikma Pharmaceuticals (OTCPK:HKMPF), and Amphastar Pharmaceuticals (AMPH)
• However, the notice does not permit an immediate switch to nonprescription/ OTC naloxone. Manufacturers will still have to submit additional supporting data to obtain the regulatory nod for the nonprescription product.
• “Today’s action supports our efforts to combat the opioid overdose crisis by helping expand access to naloxone,” FDA Commissioner Robert Califf said.
• A recent opioid settlement Teva (TEVA) reached in California included a condition to supply $20M worth of naloxone.