FDA approves over-the-counter sales of Narcan opioid overdose treatment

The Food and Drug Administration announced Wednesday that it has approved over-the-counter sales of a nasal treatment for opioid overdoses for the first time.

The FDA has given Narcan the go-ahead to be sold on store shelves, according to the organization, which claims that Wednesday’s steps will make the” life-saving medication” more widely accessible to those in need.

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” The FDA is still dedicated to resolving the opioid crisis’ complex evolving issues. According to FDA Commissioner Robert Califf in a speech, the organization has used its regulation responsibility to facilitate greater access to naloxone by promoting the creation and approval of an over-the-counter drug to treat the urgent public health need.

OTC naloxone nasal spray has been given approval approval, which will help expand availability of the drug, increase access to it, and lower opioid overdose deaths across the nation. We urge the company to prioritize making the product accessible by making it accessible as soon as possible and for a fair price ,” he continued.

The medication has now been authorized for over-the-counter price after being previously approved for prescription use in 2015. Last month, an FDA advisory panel unanimously decided to suggest the oral solution for OTC revenue.

The manufacture of Narcan, Emergent BioSolutions, will decide when the OTC solution will be available and how much it will cost, according to the FDA.

The FDA’s approval of the treatment for use without a prescription was praised by Robert G. Kramer, president and CEO of Emergent BioSolutions, who referred to it as” historic step.”

Given the alarming rates of narcotic overdoses occurring across the nation, Kramer said that today’s monument FDA OTC authorization for Narcan Nasal Spray” marks a historic milestone as we have delivered on our commitment to make this crucial emergency treatment generally accessible.”

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He continued,” We must collaborate with officials from government, retail, and advocacy groups to start increasing access and availability, as well as educate the public on the dangers of opioid overdose and the importance of being prepared with Narcan Nasal Spray to make save a life. We are dedicated to improving public health and supporting those working tirelessly to end the opioid crisis.

From October 2021 to October 20, 2022, the Centers for Disease Control and Prevention reported 101,751 opioid overdose deaths in the United States.