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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 9/22/2021 (updated 4/3/2024)
PCSS's PCSS-Implementation (PCSS-I) initiative is here to support clinicians and their clinical programs by implementing medications for opioid use disorder (MOUD) into your practice.
PCSS-I has clinical and implementation experts as PCSS-I Facilitators available to work with you and your team to develop strategies tailored specifically to support your needs. There is no cost to participate.
Posted 7/28/2021 (updated 4/2/2024)
The most effective treatments for opioid use disorder (OUD) are the three prescription medications approved by the U.S. Food and Drug Administration (FDA)—methadone, buprenorphine, and naltrexone—that are proved to increase a patient’s treatment retention and reduce illicit use and the risk of overdose. The only facilities legally able to offer all three medications are opioid treatment programs (OTPs), a critical component of the U.S. substance use treatment system that are regulated by the federal Drug Enforcement Administration (DEA) and Substance Abuse and Mental Health Services Administration (SAMHSA), as well as state agencies, and are certified to administer any FDA-approved medication for the treatment of OUD.
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 4/4/2023 (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 3/22/2022 (updated 3/27/2024)
Yesterday, the Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), is announcing two grant programs totaling $25.6 million that will expand access to medication-assisted treatment for opioid use disorder and prevent the misuse of prescription drugs. By reducing barriers to accessing the most effective, evidenced-based treatments, this funding reflects the priorities of HHS' Overdose Prevention Strategy, as well as its new initiative to strengthen the nation's mental health and crisis care systems.
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.