Leah Kuntz

The Centers for Disease Control and Prevention (CDC) recently reported that more than 100,000 people in the United States died of overdose in the 12 months ending April 2020. In response, the Drug Policy Alliance (DPA), National Harm Reduction Coalition, and People’s Action and VOCAL-NY led a group of 240 civil rights, drug policy, criminal justice reform, public health, and faith-based organizations in urging members of Congress to pass legislation that will prioritize the beating the 

They specifically urged Congress to consider evidence-based public health approaches, including critical harm reduction funding, the MAT Act, the STOP Fentanyl Act, and the Medicaid Reentry Act.

“With over 100,000 people dying of overdose in the US during the first year of the pandemic, passing these critical pieces of legislation is not only more urgent than ever before—it’s literally a matter of life and death for so many people,” said Maritza Perez, Director of the Office of National Affairs at the Drug Policy Alliance. 

“We are far past the point of waiting for a politically convenient time to take the necessary steps to curb this crisis and save lives. The US Government has targeted and criminalized our communities for drugs over the last 50 years as a political ploy which has only fueled the overdose crisis. With countless more lives at stake, it’s time to stop playing politics and continuing down this ill-fated path. It is absolutely imperative that policymakers change course immediately and prioritize evidence-based public health alternatives that are proven to actually save lives.”

Their statement urges Congress to enact life-saving legislation by the end of the 2022, including the following 4 items:

1. $69.5 million in funding to increase access to overdose prevention, harm reduction, and syringe service programs through the CDC’s Infectious Diseases and the Opioid Epidemic program.

2. The Mainstreaming Addiction Treatment Act, which eliminates the outdated requirement that practitioners apply for a separate waiver through the Drug Enforcement Administration to prescribe 

 for the treatment of substance use disorders.

3. The Support, Treatment, and Overdose Prevention of Fentanyl Act, or the STOP Fentanyl Act, which improves fentanyl surveillance and detection.

4. The Medicaid Reentry Act, which would allow Medicaid to cover health services during the last 30 days of incarceration and create better linkages to community-based care during reentry.

—through evidence-based, public health solutions,” said Sondra Youdelman, People’s Action Campaigns Director. “Our communities just suffered a record-breaking 100,000 preventable overdose deaths in a single year. Instead of continuing to criminalize drug use, Congress needs to take evidenced-based action now, and listen to the people who lost 100,000 loved ones.”

Jasmine Budnella, Director of Drug Policy at VOCAL-NY, echoed these sentiments: “Our nation is at a heartbreaking, infuriating watershed moment. With over 100,000 of our loved ones dying from a preventable overdose, it is a grave failure that evidence-based solutions proven to turn the tide on the overdose crisis remain out of reach. Congress must heed the calls for urgent action, and pass legislation rooted in science, harm reduction, and care before the new year. If our leaders fail to act, another year of devastating and historic overdose deaths is inevitable.”

1. Drug Policy Alliance. As overdose crisis claims record lives, coalition of 240 organizations urge Congress to pass lifesaving public health bills. News release. November 30, 2021. Accessed December 1, 2021. 

https://drugpolicy.org/press-release/2021/11/overdose-crisis-claims-record-lives-coalition-240-organizations-urge-congress

Articles

A coalition of 240 organizations came together to urge Congress to pass legislation to fight the opioid crisis.

Evidence-Based Solutions for Stopping the Opioid Crisis

The US Food and Drug Administration has approved Tris Pharma’s Dyanavel XR (amphetamine), extended release once-daily tablets for the treatment of 

 (ADHD) in patients aged 6 years and older.

“The Dyanavel XR Tablet represents an important treatment option for patients with ADHD,” said Andrew J. Cutler, CMO, of the Neuroscience Education Institute and clinical associate professor of psychiatry at the SUNY Upstate Medical University. “Knowing that ADHD in adults presents differently than in children, and as different adults have different treatment goals, Dyanavel XR once-daily tablet was designed and developed with the intent to provide adults with ADHD a treatment option that kicks in quickly and lasts throughout their workday and beyond.”

Dyanavel XR is a central nervous system stimulant prescription medicine used for the treatment of ADHD in individuals aged 6 years and older.

There is a significant body of research to support this approval. In a clinical study, Dyanavel XR extended-release tablets were deemed to be bioequivalent to Dyanavel XR extended-release oral suspension. In a phase 3 study of children aged 6 to 12 with ADHD, demonstrated ADHD symptom improvement occurred within 1 hour and lasted 13 hours after once-daily dosing. Additionally, in an exploratory study, Dyanavel XR oral suspension appeared to improve ADHD symptoms as quickly as 30 minutes after dosing.

“Dyanavel XR oral suspension and now Dyanavel XR tablets provide a unique pharmacokinetic profile and a broad range of dosing options for patients needing an amphetamine for their ADHD,” said James Hackworth, PhD, President of the Tris Branded Products Division.

Dyanavel XR tablets demonstrated statistically significant improvement versus placebo in mean Permanent Product Measure of Performance Total (PERMP-T) scores averaged across all post-dose time points measured in a separate double-blind, placebo-controlled, fixed-dose phase 3 study in adults with ADHD. The PERMP-T—a validated and FDA-accepted, skill-adjusted, timed math test—is used to assess attention in people with ADHD. The most common adverse reactions experienced by participants were 

, dry mouth, headache, irritability, nausea, dizziness, initial insomnia, and tachycardia.

As it contains amphetamine, Dyanavel XR is a federally controlled substance (CII). Dyanavel XR tablets are expected to be stocked in pharmacies in the first quarter of 2022.

This article originally appeared on Psychiatric Times.

1. Tris Pharma announces FDA approval of Dyanavel XR (amphetamine) once-daily extended-release oral tablets, CII, for ADHD. BioSpace. News release. November 5, 2021. Accessed November 8, 2021. 

https://www.biospace.com/article/releases/tris-pharma-announces-fda-approval-of-dyanavel-xr-amphetamine-once-daily-extended-release-oral-tablets-cii-for-adhd/

Single-dose pharmacokinetics of amphetamine extended-release tablets compared with amphetamine extended-release oral suspension.

The FDA has approved Dyanavel XR, extended release once-daily tablets for the treatment of attention-deficit/hyperactivity disorder. 

Unique Pharmacokinetic Profile, Range of Dosing Options WIth New FDA Approved ADHD Treatment 

A clinical trial studying a vaccine for opioid use disorder developed by University of Minnesota Medical School researchers has enrolled its first participants. The phase 1 randomized placebo-controlled trial, funded by a grant from the National Institutes of Health, will test the safety and potential efficacy of a vaccine that could prevent both the euphoric and toxic effects of oxycodone.

“This medication approach is unique in that it can be used alone or in combination with other treatment medications and, importantly, may offer patients long-lasting protection against overdose if they relapse to opioid use. The long-term goal of this program is to develop a series of opioid vaccines that target other commonly used opioids, such as heroin and fentanyl. 

We are very excited about this research and hope to eventually provide a safe, new treatment option for patients with opioid use disorder,” said principal investigator Sandra Comer, PhD, director of the Opioid Laboratory in the Department of Psychiatry at Columbia University Vagelos College of Physicians and Surgeons.

Comer will oversee a medical team led by Jeanne Manubay, MD, the study's medical director. Manubay will monitor the patients’ response to the vaccine, including their subsequent drug use and behaviors.

Trial participants are being enrolled at Columbia University in New York City and Clinilabs Drug Development Corporation, in Eatontown, New Jersey. Participants must be between the ages of 18 and 59, must be currently using opioids and not seeking treatment for drug use, and must have prior experience with intranasal opioid use.

Marco Pravetoni, PhD’s laboratory led the development of the series of vaccines and monoclonal antibodies that counteract depressed breathing and depressed heart rate induced by oxycodone, fentanyl, and heroin in preclinical studies.

The vaccine under observation stimulates the body’s immune system to produce antibodies to oxycodone. When a vaccinated individual takes oxycodone, the antibodies bind to the drug molecule and stop it from entering the brain, ultimately preventing the high the drug produces. As the vaccine selectively targets oxycodone, it will not interfere with US Food and Drug Administration approved medications, like methadone, buprenorphine, naltrexone, or naloxone.

“In this study, my laboratory will conduct pharmacokinetic and immunological monitoring in blood samples from immunized volunteers to ensure that they are making antibodies to oxycodone and determine whether or not the antibodies are preventing the drug from reaching the brain,” said Pravetoni.

The study plans to enroll up to 45 participants, who will be closely monitored for several weeks in inpatient units at Columbia University Irving Medical Center and at Clinilabs. Researchers will look for adverse events, determine participants’ response to oxycodone after vaccination, and then study their drug behavior on an outpatient basis.

“Clinilabs is privileged to be working with the University of Minnesota Medical School and Columbia University on this groundbreaking trial. Exploring a preventative vaccine to treat opioid use disorder has the potential to be life-altering for patients and their families who are battling opioid abuse,” said Gary Zammit, Clinilabs’ President and CEO.

Anti-Fentanyl Vaccines as Medical Solutions to Overdose Deaths

1. First-in-human clinical trial for a vaccine to treat opioid use disorders enrolls first patients. 

. September 7, 2021. Accessed September 14, 2021. 

https://www.worldpharmanews.com/index.php?option=com_content&view=article&id=5792:first-in-human-clinical-trial-for-a-vaccine-to-treat-opioid-use-disorders-enrolls-first-patients&catid=13:research

A vaccine that prevents oxycodone from entering the brain? This might be the safe, long-lasting, cost-effective solution for opioid use disorders.

First Participant Enrolled in Trial for Vaccine to Treat Opioid Disorders 

 from the American Medical Association (AMA), opioid prescriptions have gone down 44.4% nationwide in the past decade, and 6.9% from 2019 to 2020. Yet the country is experiencing a worsening overdose epidemic.

In order to address the epidemic, the AMA is urging policymakers to remove barriers to evidence-based care, and thus reduce mortality and improve patient outcomes.

“The nation’s drug overdose and death epidemic has never just been about prescription opioids,” said AMA President Gerald E. Harmon, MD. “Physicians, have become more cautious about prescribing opioids, are trained to treat opioid use disorder and support evidence-based harm reduction strategies. We use PDMPs [prescription drug monitoring programs] as a tool, but they are not a panacea. Patients need policymakers, health insurance plans, national pharmacy chains and other stakeholders to change their focus and help us remove barriers to evidence-based care.”

The report shows that, despite increased use of PDMPs, overdose and deaths are spiking. According to the report, physicians and other mental health professionals used state PDMPs more than 910 million times in 2020, and about 750 million times in 2019.

“With record-breaking numbers of overdose deaths across the country, these are actions policymakers and other stakeholders must take,” Harmon said. “The medical community will continue to play its part, and overall, the focus of our national efforts must shift. Until further action is taken, we are doing a great injustice to our patients with pain, those with a mental illness and those with a substance use disorder.”

Here are the AMA’s 7 recommendations for policymakers:

1. Remove barriers to evidence-based care for patients with a substance use disorder (SUD), including removing prior authorization and step therapy for medications to treat opioid use disorder, continuing federal flexibilities for take-home medication for opioid treatment programs, and continuing telehealth options for patients.

2. Remove barriers to opioid medications and treatment for SUDs in jails and prisons. There is no legal, medical, or policy reason to deny access to mental health care for incarcerated individuals.

3. Protect families by increasing access to evidence-based care rather than using the threat of family separation for persons who are pregnant, peripartum, postpartum, and parenting.

4. Support patients with pain by rescinding arbitrary laws and policies focused on restricting access to multidisciplinary, multimodal pain care. This might mean requiring health insurance companies and other payers to make nonopioid pain care alternatives more accessible and affordable.

5. State insurance commissioners, attorneys general, and the US Department of Labor must increase efforts to review health insurers’ policies on a regular basis to ensure they comply with the Mental Health Parity and Addiction Equity Act—and hold them accountable if not.

6. Support increased efforts to expand sterile needle and syringe exchange services programs, decriminalize drug checking supplies, and urge manufacturers to make naloxone available over the counter.

7. Develop and implement systems to collect timely, adequate, and standardized data to identify at-risk populations, fully understand polysubstance drug use, and implement public health interventions that directly address removing structural and racial inequities.

“Policymakers and other stakeholders have a choice of whether to pursue evidence-based strategies to support patients’ access to lifesaving and life- affirming care. Every effort must be made to remove health inequities and other barriers for patients with substance use disorders, mental illness and patients with pain. More of our loved ones will suffer and die if these barriers remain,” said Bobby Mukkamala, MD, Chair of the AMA Substance Use and Pain Care Task Force.

To read more on states’ efforts to combat the opioid crisis, see 

Reducing Opioid-Involved Overdose Deaths: States’ Prevention and Response Efforts

This article originally appeared on Psychiatric Times

1. American Medical Association. 2021 Overdose Epidemic Report. September 21, 2021. 

https://end-overdose-epidemic.org/wp-content/uploads/2021/09/AMA-2021-Overdose-Epidemic-Report_92021.pdf

2. American Medical Association. Report shows decreases in opioid prescribing, increase in overdoses. News release. September 21, 2021. 

https://www.ama-assn.org/press-center/press-releases/report-shows-decreases-opioid-prescribing-increase-overdoses

The American Medical Association is urging policymakers to act now to prevent further opioid overdose deaths.

