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GAITHERSBURG, Md. — Emergent BioSolutions announced Wednesday that the U.S. Food and Drug Administration (FDA) has approved NARCAN Naloxone HCl Nasal Spray 4 mg as an over-the-counter (O-T-C) emergency treatment of opioid overdose. This decision comes at a time when approximately every eight minutes, a person dies from an opioid overdose and research shows the epidemic is escalating in the U.S. with the rise in synthetic opioids. By offering NARCAN Nasal Spray as an O-T-C treatment, anyone will be able to access it without a prescription, which is an important step in the fight to reduce the number of opioid overdose deaths occurring each day.
“Our lives changed forever when our 16-year-old son, Sammy, passed away in his bedroom after taking a medication laced with fentanyl that he purchased through a social media site,” said Dr. Laura Berman, psychotherapist, PhD and well-known author, radio, TV, and podcast host. “Since Sammy’s passing, we’ve learned that if we had a form of naloxone in our home, we may have been able to save him. With today’s over-the-counter approval of NARCAN Nasal Spray, more families can be prepared, so they don’t experience the same heartache.”
NARCAN Nasal Spray was developed for use in the community setting and more than 44 million doses have been distributed since its launch in 2016. This prescription-to-OTC approval is supported by Human Factors study data, an updated Drug Facts label, pharmacovigilance data collected from various public sources, and seven years of post-marketing safety data. The new OTC product will have the same formulation, device design, and original prescription strength (4 mg), which are important features and benefits to help counteract the effects of opioids, including fentanyl, in the community setting.
“Today’s landmark FDA OTC approval for NARCAN Nasal Spray marks a historic milestone as we have delivered on our commitment to make this important emergency treatment widely accessible, given the alarming rates of opioid overdoses occurring across the country,” said Robert G. Kramer, president and CEO of Emergent BioSolutions. “We are dedicated to improving public health and assisting those working hard to end the opioid crisis – so now with leaders across government, retail and advocacy groups, we must work together to continue increasing access and availability, as well as educate the public on the risks of opioid overdoses and the value of being prepared with NARCAN Nasal Spray to help save a life.”
Emergent anticipates NARCAN Nasal Spray will be available on U.S. shelves and at online retailers by the late summer to account for manufacturing changes that will be implemented to support nonprescription packaging, as well as supply chain modifications. In the meantime, the prescription product will remain in readily available supply through current access channels, including pharmacies through standing order or co-prescription laws and through community distribution. For more information, visit NARCAN.com.
The Consumer Healthcare Products Association (CHPA) released the following statement on the decision:
“CHPA applauds FDA for taking a critical step forward today in public health by making Narcan available over-the-counter – previously only available with a prescription – which will remove many of the barriers and stigmas attached to this life-saving emergency therapy for opioid overdoses,” said CHPA president and CEO Scott Melville. “Since naloxone is used in emergency situations where every second counts, OTC access will now give individuals, families, friends, and other responders quicker access to this medication. It will also increase the likelihood that individuals will obtain and carry Narcan, which will potentially save more lives. Today’s decision will positively impact millions of Americans and provide benefits that Rx-to-OTC-switch products have always delivered: increased access to safe, effective, and affordable medicines for better healthcare.”
