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12 Results (showing 1 - 10)
Results sorted by updated date (oldest first)
Results sorted by updated date (oldest first)
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 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 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 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 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 1/17/2023 (updated 3/27/2024)
The Consolidated Appropriations Act of 2023 removed the federal requirement for providers to have an X-waiver to prescribe medications for the treatment of OUD. The act amended the Controlled Substances Act. Depending on state law, practitioners who have a current DEA registration with Schedule III authority will be able to prescribe buprenorphine for OUD starting now.
Posted 3/7/2023 (updated 3/27/2024)
n December 2022, Congress eliminated the DATA-Waiver program registration allowing providers to prescribe buprenorphine to treat patients for OUD. The University of Vermont Center on Rural Addiction, a HRSA Rural Center of Excellence on Substance Use Disorders, offers an incentive to help defray previous training costs of $750 to each qualifying provider who obtained a DATA-Waiver. To qualify, providers must be practicing in a HRSA-designated rural county in Vermont, Maine, New Hampshire, or Northern New York.
Posted 10/27/2023 (updated 3/28/2024)
As announced by the Substance Abuse and Mental Health Services Administration in January 2023, clinicians no longer need a federal waiver to prescribe buprenorphine for treatment of opioid use disorder. Clinicians will still be required to register with the federal Drug Enforcement Agency (DEA) to prescribe controlled medications. On June 27, the DEA began to require that registration applicants – both new and renewing – affirm they have completed a new, one-time, eight-hour training.
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 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.