Gaithersburg’s Emergent BioSolutions Reports FDA Advisory Committees’ Unanimous Vote in Favor of NARCAN Nasal Spray for Over-The-Counter Use

If approved by the FDA, NARCAN Nasal Spray will be the first 4 mg naloxone nasal spray switched from prescription status to over-the-counter use

Gaithersburg-based Emergent BioSolutions announced the U.S. Food and Drug Administration (FDA) Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committeehave unanimously voted in favor (a total of 19 votes) that the benefit-risk profile of NARCAN®(naloxone HCl) Nasal Spray is supportive of its use as a nonprescription opioid overdose reversal agent. Emergent presented an overview of its over-the-counter (OTC) development program, the medical need, Human Factors study data and seven years of post-marketing safety data. The FDA is not bound by the committees’ guidance but will take its advice into consideration.

“This favorable recommendation marks another important step forward to broaden access to NARCAN Nasal Spray for those who may be at risk of an opioid overdose,” said Paul Williams, SVP and Products Business Head, Emergent BioSolutions. “Today’s vote reaffirms our confidence in the safe and effective use of NARCAN in the community setting. We want to thank the participants in the open public hearing who shared their insights and personal experiences informing the need to make NARCAN more readily available over the counter.”

According to the United States Centers for Disease Control and Prevention, more than 107,000 Americans lost their lives to a drug overdose in 2021, of which more than 70,000 were a result of using synthetic opioids containing fentanyl.1 The rise in opioid-related deaths, including the increase associated with use of fentanyl, specifically during the COVID-19 pandemic, has prioritized the need to expand access to opioid overdose reversal treatment.

“Bystanders are present at nearly half of fatal overdoses, yet naloxone is administered in only a small percentage of those cases,” 2 said Dr. Joshua Lynch, Clinical Associate Professor of Emergency and Addiction Medicine, University at Buffalo Jacobs School of Medicine and Biomedical Sciences. “The reality is accidental overdoses can happen to anyone, anywhere, at any time, and we can all do our part by being prepared to help like we would in any other emergency. With access to over-the-counter naloxone, we would have a critical opportunity to close this gap and reduce the number of opioid-related deaths.”

Emergent was the first company to submit a supplemental New Drug Application for OTC and received Priority Review by the FDA. If approved, NARCAN would be the first 4 mg naloxone nasal spray available OTC in the U.S. The Prescription Drug User Fee Act goal date is March 29, 2023. Emergent will continue to work with policymakers, retailers, advocates and other stakeholders to help ensure policies and solutions are implemented to increase access and awareness of this potentially lifesaving medicine.

INDICATION AND IMPORTANT SAFETY INFORMATION

What is NARCAN Nasal Spray?

  • NARCAN Nasal Spray is a prescription medicine used for the emergency treatment of a known or suspected opioid overdose emergency with signs of breathing problems and severe sleepiness or not being able to respond.
  • NARCAN Nasal Spray is to be given right away and does not take the place of emergency medical care. Get emergency medical help right away after giving the first dose of NARCAN Nasal Spray, even if the person wakes up.

NARCAN Nasal Spray is safe and effective in children for known or suspected opioid overdose.

Who should not use NARCAN Nasal Spray?

Do not use NARCAN Nasal Spray if you are allergic to naloxone hydrochloride or any of the ingredients in NARCAN Nasal Spray.

What is the most important information I should know about NARCAN Nasal Spray? NARCAN Nasal Spray is used to temporarily reverse the effects of opioid medicines. The medicine in NARCAN Nasal Spray has no effect in people who are not taking opioid medicines. Always carry NARCAN Nasal Spray with you in case of an opioid overdose.

Featured photo courtesy of Google Maps

Recent Stories

Montgomery County Board of Education President Karla Silvestre and Dr. Monique Felder, Interim Superintendent of Montgomery County Public Schools have released the following statement regarding the FY 2025 operating budget:

The Maryland State’s Attorney’s Office has released the body-cam footage from a fatal collision that occurred following an attempted traffic stop on Rockville Pike last month.

Kung Fu Tea, located at 19717 Frederick Rd in Germantown, has announced it will hold its grand opening celebration from May 31 to June 2.

Back in January, Bao Bei at 11910 Parklawn Dr #O in Rockville temporarily closed to participate in a reality TV food competition. It has now been revealed that Bao Bei…

Washington City Paper is hosting its annual Best of D.C. contest -- and Well-Paid Maids is eyeing the Best Maid Service category. If you missed it: Well-Paid Maids has secured first place for the past three years. Can you help us snag gold again? Simply go to the ballot and write in your vote for the best maid service. In case you need a refresher before you vote, Well-Paid Maids is the only certified living-wage cleaning company in the D.C. area. We pay our cleaners, who are W-2 employees, at least $24 an hour and offer benefits like insurance, 24 paid days off per year and more. Voting is open until June 10 at 5 p.m., and the winner will be announced July 18. (We'll keep you posted!) Thank you for your support -- and if you still haven't booked a spring cleaning yet, now is the time!

Submit your own Announcement here.

Oak Chapel is excited that Priority Partners Managed Care Organization (PPMCO) in partnership with Johns Hopkins HealthCare (JHHC) have selected the Oak Chapel Hub as the location for the first mini-food pantry/mini library in Montgomery County. Please join us for the cupboard unveiling on Saturday, May 18th, at 10 AM (rain or shine). This is scheduled to be an outdoor event. If there is inclement weather, the event will be held in the multi-purpose room of the main church building (Hub distribution location). The cupboard will be fully stocked and ready for the community to take what they need and leave what they can. It is a privilege to be able to continue to serve the 20906 community.

Fighting food insecurity, feeding families.

Submit your own Announcement here.

Movie being filmed in McLean, VA, needs your support

A local community movie is filming in our area in June and needs contributions!

Local actors, teens, teachers, housewives, and retired residences are trying to make this film happen but we need your help.

This is an educational short story about teens learning how to navigate when they don't feel accepted by their friends and what to do to find acceptance. Yet this film isn't just for teens. In your life have you ever felt like you weren't accepted??

Come be a part of the audience for this film! Invite your friends. Be a part of this film being produced right here in our area.

This is a social impact film that will show locally and internationally at film festivals in 2025 and also at colleges.

More information can be found here. DONATE TODAY:

https://www.filmindependent.org/sponsored-projects/ultimate-bias/

https://www.silvanomarifilms.com/jis

This is a not-for-profit film and donations are tax-deductible.

Free Community Father-Daughter Dance

Fathers and father figures, create unforgettable memories with your daughter at our free community father-daughter dance on June 1st, from 6-8 pm. Hosted outdoors at Olney Baptist Church. This event offers a delightful outdoor experience complete with a DJ spinning tunes, interactive games, a charming photo booth, delicious treats, and exciting raffle prizes. Fathers/father figures and daughters of all ages are warmly welcomed to share in this special evening together. Join us for an evening of joy, laughter, and cherished moments!

In the spirit of giving back to our community, we are partnering with Quest to Feed Montgomery to make a meaningful difference in the lives of those in need. We kindly ask each attendee to bring along a non-perishable food item to donate during the event. Every contribution, no matter how small, will go a long way in supporting families facing food insecurity in our area.

×

Subscribe to our mailing list