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7 Results (showing 1 - 7)
Results sorted by posted date (oldest first)
Results sorted by posted date (oldest first)
Posted 5/3/2021 (updated 4/10/2024)
The U.S. Food and Drug Administration (FDA) announced on April 30, 2021 the approval of a higher dose naloxone hydrochloride nasal spray product to treat opioid overdose. The newly approved product delivers 8 milligrams (mg) of naloxone into the nasal cavity. The FDA had previously approved 2 mg and 4 mg naloxone nasal spray products.
Naloxone is a medicine that can be administered by individuals with or without medical training to help reduce opioid overdose deaths. If naloxone is administered quickly, it can counter the opioid overdose effects, usually within minutes. A higher dose of naloxone provides an additional option in the treatment of opioid overdoses.
Posted 8/4/2021 (updated 4/2/2024)
Posted 10/14/2021 (updated 4/3/2024)
Stimulant intoxication, withdrawal, and psychosis have accepted and established treatment strategies. Several lifesaving harm reduction interventions/services are available. There are no Food and Drug Administration-approved medications for treatment of stimulant use disorder, although several are promising. Behavioral treatment, especially the use of contingency management (and other approaches with supportive evidence), has by far the best evidence of effectiveness. The presenter reviewed topics of importance to clinicians treating individuals with stimulant use disorder.
Rick Rawson, PhD, University of Vermont Rural Center of Excellence
Posted 4/4/2023 (updated 3/27/2024)
The U.S. Food and Drug Administration (FDA) announced that the makers of Narcan, an opioid overdose treatment, have the agency’s approval to make the drug widely available over the counter (OTC). Narcan is the brand name of the drug naloxone, a fast-acting overdose reversal. Until now, availability varied by state – typically restricted to licensed health care providers, approved opioid overdose programs, and first responders. This is an important consideration for rural counties given that research shows that these areas are nearly three times more likely than metropolitan counties to be a low-dispensing county for naloxone.
Posted 5/26/2023 (updated 3/27/2024)
The U.S. Food and Drug Administration approved Brixadi (buprenorphine) extended-release injection for subcutaneous use (under the skin) to treat moderate to sever opioid use disorder (OUD). Buprenorphine is a safe and effective medication for OUD treatment.
Posted 7/31/2023 (updated 3/26/2024)
At the end of July 2023, the U.S. Food and Drug Administration approved a second over-the-counter naloxone nasal spray product, RiVive. The agency who received the approval to manufacture the product, Harm Reduction Therapeutics, does not yet have a timeline of availability and decision on pricing.
Posted 1/19/2024 (updated 3/28/2024)
The FDA announced that the manufacturer of NARCAN 4 mg Nasal Spray products, Emergent BioSolutions, has extended the shelf-life of their product from 3 years to 4 years. This new extension of shelf-life was requested by the FDA to help prevent overdoses and reduce overdose-related deaths.