It won't be on the shelf at your local pharmacy next week, but a major regulatory hurdle has been cleared.
In the wake of an escalating opioid crisis, members of a joint Food and Drug Administration (FDA) advisory committee gave the green light to an over-the- counter (OTC) version of prescription naloxone nasal spray, an opioid overdose reversal agent.
Every member of the Nonprescription Drugs Advisory Committee (NDAC) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) agreed that the evidence of benefits from switching the drug to OTC status far outweighs the minimal risks.
"The unanimity of the committee is a profound statement about how important this is," voting member Jeffrey Brent, MD, PhD, distinguished clinical professor of medicine and emergency medicine, University of Colorado, Aurora, said during the meeting.
https://www.medscape.com/viewarticle/988378
FDA Panel Gives Unanimous Thumbs Up to OTC Naloxone
In the wake of an escalating opioid crisis, members of a joint Food and Drug Administration (FDA) advisory committee gave the green light to an over-the- counter (OTC) version of prescription naloxone nasal spray, an opioid overdose reversal agent.
Every member of the Nonprescription Drugs Advisory Committee (NDAC) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) agreed that the evidence of benefits from switching the drug to OTC status far outweighs the minimal risks.
"The unanimity of the committee is a profound statement about how important this is," voting member Jeffrey Brent, MD, PhD, distinguished clinical professor of medicine and emergency medicine, University of Colorado, Aurora, said during the meeting.
https://www.medscape.com/viewarticle/988378