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Naloxone, packaged with instructions, is one of the items given out by the Baltimore Harm Reduction Coalition outreach workers. The U.S. Food and Drug Administration has approved the prescription-free sale of the second opioid overdose reversal drug, its manufacturer Harm Reduction Therapeutics said on Friday. The approval of the drug, called RiVive, will provide patients with another over-the-counter option in the United States, where drug-related overdose deaths surpassed 100,000 in 2021. Harm Reduction said it anticipates that RiVive will be available early next year, primarily to harm-reduction organizations and state governments. Harm Reduction Therapeutics has partnered with contract drug manufacturer Catalent Inc to manufacture RiVive.
Persons: drugmaker, Michael Hufford, BioSolutions Organizations: Reduction Coalition, U.S . Food, Drug Administration, Therapeutics, Harm, Catalent Inc Locations: Baltimore, U.S, United States
Naloxone, packaged with instructions, is one of the items given out by the Baltimore Harm Reduction Coalition outreach workers. The Food and Drug Administration on Tuesday indicated it might approve over-the-counter nasal sprays and autoinjectors that prevent opioid overdoses, part of its efforts to expand access to a life-saving drug called naloxone. The FDA, in a preliminary assessment, said nasal spray containing up to 4mg of naloxone and autoinjectors that administer up to a 2 mg dose of the drug might be safe and effective for people to self administer without a prescription. Opioid overdose deaths surged 65% during the Covid-19 pandemic from 47,000 in 2019 to nearly 78,000 in 2021, according to data from the Centers for Disease Control and Prevention. More than 564,000 people have died from opioids in the U.S. since 1999 in three waves — first from prescription opioids, then from heroin and most recently from fentanyl.
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