FDA批准纳洛酮鼻喷剂转为非处方药

On March 29, 2023, Emergent announced that the U.S. Food and Drug Administration (FDA) has approved 4 mg of naloxone hydrochloride nasal spray (Narcan®) as an over-the-counter (OTC) drug for the emergency treatment of opioid overdose.

When someone overdoses on opioids, they may have difficulty awakening, have shallow breathing, or even stop. Without medical intervention, death may result. If Naloxone is used promptly, overdose symptoms can usually be relieved within two minutes.

Robert G. Cramer, President and CEO of Emergent, said on the FDA's approval of naloxone nasal spray as an over-the-counter drug: "Given the alarming incidence of opioid overdoses across the country and around the world, today's FDA approval of naloxone nasal spray as an over-the-counter drug is a historic milestone and fulfills our commitment to making this important emergency treatment widely available. We are committed to improving public health and assisting those working to end opioids." People working to fight the drug crisis. Now we must work together with leaders in government, retail and advocacy groups to continue to expand access and supply, while educating the public about the risks of opioid overdoses and keeping naloxone nasal spray on hand to save the day. The importance of life. ”

About Naloxone Nasal Spray (Narcan)

4 mg is the first over-the-counter product approved by the U.S. Food and Drug Administration for the emergency treatment of opioid overdose. Naloxone nasal spray is not a substitute for emergency medical care and may require repeated administration. Please use it as directed by your doctor.

FDA approves naloxone nasal spray for the first time for opioid overdose

On November 18, 2015, the U.S. Food and Drug Administration (FDA) today approved the marketing of naloxone nasal spray. This is the first FDA-approved naloxone hydrochloride nasal spray dosage form. The drug is a life-saving drug that can prevent or reverse the effects of opioid overdose.

Naloxone nasal spray requires no assembly and delivers a consistent, precise dose when used as directed. This prescription medication is available for adults or children and can be easily used by anyone without medical training. To administer the drug, have the patient lie on his back and spray the drug into one nostril, repeating the dose if necessary. However, it should be noted that it is not a substitute for immediate medical care. After using naloxone nasal spray, the administerer should immediately seek further medical assistance for the patient.