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6 Results (showing 1 - 6)
Results sorted by updated date (newest first)
Results sorted by updated date (newest 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 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.
Posted 4/11/2023 (updated 3/27/2024)
The first phase of the campaign created by the White House Office of National Drug Control Policy (ONDCP) and Ad Council was launched to education young people on the dangers of fentanyl and the life-saving effects of Naloxone, a medicine that reverses opioid-related overdoses. This campaign expands on the Ad Council's The Real Deal on Fentanyl platform.
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 3/14/2023 (updated 3/27/2024)
The Drug Enforcement Administration (DEA) announced proposed rules for the prescribing of controlled medications via telemedicine beyond the end of the COVID-19 public health emergency. One rule addresses the expansion of induction of buprenorphine via telemedicine encounter while the other covers telemedicine prescribing of controlled substances when the practitioner and the patient have not had a prior in-person medical evaluation. While opioid use disorders occur at similar rates in both rural and urban areas, medication assisted treatment (MAT) prescribers have been disproportionately located in urban areas. The public will be able to comment on the proposed rules until March 31st.
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.