FDA Approves Over-the-Counter Naloxone Nasal Spray

On March 29, the Food and Drug Administration (FDA) approved the first over-the-counter (OTC) 4-mg naloxone nasal spray for non-prescription use and purchase. While pricing is still being determined, the product is expected to be released by Summer 2023. Other brands of naloxone will continue to be available in pharmacies with a prescription and FDA will work with stakeholders to ensure access to naloxone continues during the transition period. According to FDA, other naloxone manufacturers will have the opportunity to submit a supplement to their application and update their OTC status. This approval follows the February joint meeting of the Nonprescription Drugs Advisory Committee (NDAC) and Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) where the advisory panels unanimously voted to recommend the nasal spray becoming an over-the-counter emergency treatment for opioid overdose. In response to the news of the approval, Secretary Califf stated, “Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available, and help reduce opioid overdose deaths throughout the country.”

Articles & Resources

FDA – FDA Approves First Over-the-Counter Naloxone Nasal Spray

HHS—The Biden Harris Administration Takes Critical Action to Make Naloxone More Accessible and Prevent Fatal Overdoses from Opioids Like Fentanyl

Congress Introduces Legislation to Confront Xylazine

On March 28, lawmakers in the House of Representatives and the Senate introduced the Combating Illicit Xylazine Act. This bipartisan, bicameral legislation will recognize the dangers of xylazine and confront its illicit use. The bill was introduced by Senators Catherine Cortez Masto (NV), Chuck Grassley (IA), and Maggie Hassan (NH) and by Representatives Jimmy Panetta (CA-19), August Pfluger (TX-11), Gus Bilirakis (FL-12), Ken Buck (CO-04), and Chris Pappas (NH-01). The bill has five key goals:

1. Classify xylazine’s illicit use as Schedule III under the Controlled Substances Act;

2. Enable the DEA to track manufacturing to limit diversion;

3. Require a report on prevalence, risk, and recommendations on how to regulate the illicit use of xylazine;

4. Ensure all salts and isomers of xylazine are covered when restricting illicit use; and

5. Declare xylazine an emerging drug threat.

Xylazine is a veterinary tranquilizer not approved for use in humans. Xylazine, also known as ‘Tranq’, has been found in fentanyl and other opioids as a cutting agent. Side effects of xylazine include slowed breathing and heart rate, unconsciousness, necrosis, and death. Xylazine is not an opioid, is resistant to Narcan, and increasingly found in overdose deaths.

Articles & Resources

Bill Text

S.993 – Combatting Illicit Xylazine Act

H.R. 1839 – Combatting Illicit Xylazine Act

What We Read Last Week

Several articles were published last week pertaining to the opioid epidemic, covering a variety of different components of the topic. Links to relevant articles are provided below.

Bloomberg – An Opioid Overdose Kit Lets Anyone Respond to an Emergency

Forbes – The One State Bucking Nationwide Opioid Abuse Trends

JAMA Psychiatry – Association of Receipt of Opioid Use Disorder-Related Telehealth Services and Medications for Opioid Use Disorder With Fatal Drug Overdoses Among Medicare Beneficiaries Before and During the COVID-19 Pandemic

PAIN – Fibromyalgia Predicts Increased Odds of Pain-Related Addiction Exacerbated Among Individuals with Pain and Opioid Use Disorder

Pharmacy Times – Pharmacists are Essential in Curbing the Opioid Crisis in Older People

SAMHSA – Dear Colleague Letter on Xylazine

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