FDA approves nalmefene nasal spray to reverse opioid overdoses
The Food and Drug Administration approved Opvee nalmefene nasal spray to reverse opioid overdoses, similar to naloxone. It will be available via prescription and is approved for patients 12 and older. The National Institutes of Health provided funding and worked with researchers on nasal spray nalmefene that would quickly resuscitate users, while also protecting them from relapse by lasting longer. However, some experts see potential downsides to a longer-lasting medication, as withdrawal symptoms created by the medication will also last longer. This could discourage use and require extra services. Some note that naloxone is available and multiple doses can be used if necessary. Maker Indivior is still considering what to charge for it, which is aimed at public interest organizations such as health departments, fire and law enforcement agencies and school districts. Some say the company is just trying to capitalize on fear and the available pots of money (e.g., opioid settlements) but that new, more expensive options are not needed given the success of naloxone.
Source: New nasal spray to reverse fentanyl and other opioid overdoses gets FDA approval (Associated Press); New overdose antidote approved, but concerns raised about cost, side effects (Washington Post)
Death rate due to alcohol, drugs and suicide increased 11% in 2021
Trust for America’s Health’s Pain in the Nation report found that the rate of deaths due to alcohol, drugs and suicide climbed 11% in 2021. According to the report, 290,225 Americans lost their lives due to alcohol, drugs or suicide in 2021, continuing a two-decade trend of increases. Overdose deaths increased by 14% between 2020 and 2021, alcohol-induced deaths increased by 10% and suicide mortality increased by 4%. The report includes recommendations, including investing in prevention and conditions that promote health (such as programs that prevent/reduce adverse childhood experiences and provide trauma-informed services, student mental health services in schools, and strengthened crisis intervention programs), and preventing substance misuse and overdose (including supporting syringe services programs, increasing naloxone and fentanyl test strip availability, and expanding funding for youth prevention programs). The report also calls for transforming the mental health and substance use prevention system (such as parity enforcement, mental health and substance use treatment integration with other health care services, and expanding culturally and linguistically appropriate care).
Source: Pain in the Nation 2023: U.S. Death Rate Due to Alcohol, Drugs, and Suicide Increased by 11 Percent in 2021 (Trust for America’s Health)
ONDCP exploring ways to expand methadone access
A growing number of experts have been pushing to allow patients to receive methadone at a doctor’s office or pharmacy, and the Biden administration appears to be moving in a similar direction. Office of National Drug Control Policy Director Rahul Gupta said that when it comes to expanding methadone access, “all options are on the table right now.” Gupta said the federal government has convened conversations between the agencies with jurisdiction over methadone. He touted the administration’s existing policies like allowing longer supplies of take-home doses and legalizing mobile methadone units. While the federal government has not formally proposed it, he floated the option of allowing patients to pick up methadone at a retail pharmacy even when it is prescribed at an opioid treatment program. Gupta also applauded the decision to delay a proposal that would have added new restrictions on buprenorphine prescribed via telehealth.
Surgeon General issues advisory on social media and youth mental health
Surgeon General Vivek Murthy released an Advisory on Social Media and Youth Mental Health, issuing a call to action to gain a better understanding of the full impact of social media use, maximize the benefits and minimize the harms of social media and create safer and healthier online environments. The Advisory offers recommendations for policymakers (strengthening safety standards, better protecting children’s privacy, supporting digital/media literacy and funding research), technology companies (better assessing the impact of products on children, sharing data with researchers, making decisions that prioritize safety/health and improving systems to respond to complaints), and parents/caregivers (establishing tech-free zones, teaching kids responsible online behavior and reporting problematic content/activity). The advisory also includes recommendations for children/adolescents (limiting time on platforms, blocking unwanted content, being careful about sharing personal information and reaching out for help) and researchers (prioritizing social media and youth mental health research to support establishment of standards). The administration also announced actions to safeguard children’s privacy, health and safety from online harms, including the creation of an interagency Task Force on Kids Online Health & Safety.
Source: Surgeon General Issues New Advisory About Effects Social Media Use Has on Youth Mental Health (Department of Health and Human Services); Fact Sheet: Biden-Harris Administration Announces Actions to Protect Youth Mental Health, Safety & Privacy Online (White House)
FDA approves new extended-release buprenorphine
The Food and Drug Administration approved Braeburn’s Brixadi buprenorphine extended-release injection for subcutaneous use to treat moderate to severe opioid use disorder. Brixadi is available in two formulations – a weekly injection that can be used in patients who have started treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine, and a monthly version for patients already being treated with buprenorphine. The formulations are approved at varying doses (8, 16, 24, 32 mg for weekly, 64, 96, 128 mg for monthly), including lower doses that may be appropriate for those who do not tolerate higher doses of extended-release buprenorphine that are currently available. The approved weekly formulation in various lower strengths offers a new option for people in recovery who may benefit from a weekly injection to maintain treatment adherence. b
Source: FDA Approves New Buprenorphine Treatment Option for Opioid Use Disorder (Food and Drug Administration)
White House announces actions to advance its mental health strategy, including to expand school-based mental health services
The administration announced actions it is taking this month to advance the President’s mental health strategy, including to strengthen the workforce and system capacity, connect more Americans to care and create healthy and supportive environments. Additionally, to expand school-based mental health services, the Education Department is proposing a rule to streamline Medicaid billing permissions for students with disabilities. The Department of Health and Human Services is issuing guidance to make it easier for schools to bill Medicaid and is approving requests from New Mexico and Oregon to expand health care services schools can deliver to Medicaid-enrolled students. The administration also announced more than $95 million to increase access to school-based mental health services and strengthen the pipeline of mental health professionals in high-need districts. Grantees will train and place thousands of diverse and certified mental health providers in schools.
Source: Fact Sheet: Biden-Harris Administration Announces New Actions to Tackle Nation’s Mental Health Crisis (White House); Biden-Harris Administration Takes Action to Help Schools Deliver Critical Health Care Services to Millions of Students (Department of Health and Human Services); Biden-Harris Administration Announces Nearly $100 Million in Continued Support for Mental Health and Student Wellness Through Bipartisan Safer Communities Act (U.S. Department of Education)
State and local news
San Francisco and Walgreens settle opioid lawsuit
San Francisco reached a $230 million settlement with Walgreens over its role in the city’s opioid crisis. The settlement came nine months after a U.S. district judge in San Francisco said the drugstore chain could be held liable for having “substantially contributed” to an opioid epidemic that caused “widespread harm” in the city and constituted a public nuisance. The judge faulted Walgreens for its failure to properly scrutinize opioid prescriptions and flag possible misuse, finding that Walgreens’ San Francisco pharmacies had received more than 1.2 million opioid prescriptions with “red flags” 2006-2020 and performed due diligence on less than 5% before dispensing them. The settlement averts a trial to determine damages. Walgreens disputes liability and did not admit fault. The company has been the only remaining defendant in San Francisco’s civil lawsuit, after several other companies reached settlements worth more than $120 million.
Source: Walgreens reaches $230 mln opioid settlement with San Francisco (Reuters)
Minnesota reaches settlement with Juul and Altria
Minnesota settled its lawsuit against Juul and Altria for $60.5 million. The lawsuit was the first and still the only one of thousands of cases nationwide against Juul to reach trial. It settled just ahead of closing arguments last month, but the terms had to be kept confidential for 30 days until the formal papers were filed publicly with the court. Juul will pay more than a third of the $60.5 million within 30 days and more than 60% within a year. The state will get about $43 million after litigation costs and attorney’s fees. Legislation is pending to dedicate the money to tobacco prevention. Minnesota will also get documents specific to the state, including Altria’s internal documents on its involvement with Juul. The settlement specifically prohibits Juul from marketing to children and young adults in Minnesota and requires the company to accurately disclose the nicotine content of its products.
Source: Minnesota gets $60.5M in settlement with e-cigarette maker Juul, tobacco giant Altria (Associated Press)
State attorneys general urge Congress to pass the Combating Illicit Xylazine Act
A bipartisan coalition of 39 state attorneys general sent a letter urging congressional leadership to pass the Combating Illicit Xylazine Act, which would provide measures to combat the illicit use and trafficking of xylazine and help prevent xylazine-related deaths. The attorneys general emphasized the importance of measures outlined in the bill, including classifying the illicit use of xylazine as a Schedule III drug, allowing the Drug Enforcement Administration (DEA) to track the manufacturing and sales and xylazine to ensure it is not diverted, requiring the U.S. Attorney General with DEA and the Food and Drug Administration to submit a report to Congress on the prevalence and risks of xylazine and recommendations on how to regulate its illicit use and ensuring all salts, isomers and other forms of xylazine are also covered when restricting its illicit use.
Other news in addiction policy
Increase in overdose deaths slowed in 2022
Overdose deaths increased slightly last year, with numbers plateauing for most of the year, after two big increases during the pandemic. Experts are unsure whether than means the crisis is reaching a peak or whether it will look like previous plateaus that were followed by new surges. The numbers are still extraordinarily high, with an estimated 109,680 overdose deaths last year. The 2% increase in 2021 compares to 30% and 15% increases in 2020 and 2021. Between 2021 and 2022, 23 states reported decreases in overdose deaths, one saw no change and the rest continued to increase. Eight states reported sizeable decreases of about 100 or more. Some of these states had some of the highest overdose death rates, so the decreases may be a sign that years of concentrated work is paying off. State officials cited various factors for the decline, like education campaigns to warn the public about the dangers of substance use, expanded treatment (including telehealth) and wider naloxone distribution.
Source: Drug overdoses in the US slightly increased last year. But experts see hopeful signs (Associated Press)
Barriers to buprenorphine and disparities in access persist
People with opioid use disorder, especially people of color, often face challenges in receiving buprenorphine. There are many reasons for disparities in access, including a lack of providers willing to prescribe it, bias in prescribing, distrust of medical institutions and racism in the health care system. Last year, the federal government made it easier for more doctors to prescribe buprenorphine by eliminating the waiver requirement and extended the pandemic-era rule allowing buprenorphine prescribing through telemedicine. However, doctors who lack experience with buprenorphine are sometimes disinclined to prescribe it. Doctors sometimes fear that patients may sell buprenorphine or not use it as prescribed, despite data showing that fears of diversion are not warranted. Researchers have found that Black and Hispanic patients in particular express stronger distrust of medications for opioid use disorder. Educating a wider array of doctors, community groups and patients is key. Even with doctors and patients who embrace buprenorphine, however, insurance can impose obstacles, including through restrictive prior authorization and dose limits.
Source: There’s medicine to quiet his opioid cravings. Getting it can be hard. (Washington Post)