This decision is in line with state laws in some of which pharmacies may sell the medication without a prescription. The naloxone-based nasal spray Narcan quickly blocks or reverses the effects of opioids and resumes normal breathing. More than 100,000 drug-related overdose deaths occurred in the US in 2021, a 15% increase from the previous year.
Access to Narcan over-the-counter
The FDA’s approval means that the 4 mg naloxone hydrochloride nasal spray (Narcan) is the first OTC naloxone product approved for use without a prescription. The authorization opens the door for direct sales of the medication to consumers in locations such as pharmacies, convenience stores, supermarkets, gas stations, and online. By the end of the summer of 2023, Emergent BioSolutions hopes to have Narcan on shelves and in online stores in the United States. The timeline of availability and price will be determined by Emergent BioSolutions.
The origins of Narcan
More than 44 million doses of Narcan have been distributed in the United States since its launch by Emergent BioSolutions in 2016. Narcan received its initial approval as a prescription drug in 2015. The first generic version of Narcan, offered by Israeli pharmaceutical company Teva Pharmaceuticals, received FDA approval in late 2021. The FDA’s recent approval of Narcan for over-the-counter use is consistent with its independent panel of advisers’ unanimous February recommendation to do so.
Emergent BioSolutions are impacted by
Analysts have stated that despite Emergent BioSolutions’ lead in the OTC product market, the company is unlikely to see a significant increase in sales as a result of the approval. According to Benchmark analyst Robert Wasserman, narcotics sales peaked in 2020 and have since decreased. In contrast to a 40% increase in 2021, Emergent reported a 14% decline in 2022 for its nasal naloxone products.
The FDA’s dedication to resolving the overdose crisis
The FDA continues to place a high priority on combating substance use disorders and has taken numerous measures to make it easier to obtain products that contain the life-saving drug naloxone. The FDA Overdose Prevention Framework places an emphasis on supporting primary prevention, promoting harm reduction, advancing the development of evidence-based treatments for substance use disorders, and safeguarding the public from illegal, mislabeled, or fake drugs that pose overdose risks.
Featured image: “Narcan”, by PunchingJudy, licensed under CC BY 2.0, on Flickr
