FDA Moves Step Closer For Opioid Overdose Medication Access, Says Certain Naloxone Products Can Potentially Be Used In OTC Setting

  • The FDA has issued a notice regarding the safety and effectiveness of certain naloxone hydrochloride products for nonprescription or over-the-counter (OTC) use.
  • Naloxone is a medicine that can help reduce opioid overdose deaths and, when administered timely, usually within minutes of the first signs of an opioid overdose, can counter the overdose effects.
  • “Today’s action supports our efforts to combat the opioid overdose crisis by helping expand access to naloxone,” said FDA Commissioner Robert M. Califf. 
  • In September, the White House announced $1.5 billion in funding to tackle opioid overdoses and remove barriers to key tools like naloxone.
  • The notice includes a preliminary assessment that certain naloxone drug products–up to 4 mg nasal spray and up to 2 mg autoinjector for intramuscular or subcutaneous use–may be approvable as safe and effective for nonprescription use. 
  • To make its final determination, the FDA needs additional data, such as product-specific data on the nonprescription user interface design.
  • The notice does not cover all naloxone products. More data are needed on the safety and efficacy of nonprescription use of higher dose naloxone products and naloxone supplied in other presentations (including vials, ampules, or syringes without integrated needles).
  • Researchers are assessing another alcohol or opioid use disorder medicine, Naltrexone, as a potential cure for long COVID.
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