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.

The "overwhelming positive support" for an OTC naloxone "underscores the importance of moving this drug to greater access and highlights the terrible risks of not acting in terms of making the drug more accessible," added meeting chair Maria C. Coyle, PharmD, associate clinical professor at the Ohio State University College of Pharmacy, Columbus.

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