In response to the growing drug crisis, the Food and Drug Administration (FDA) is encouraging pharmaceutical companies to focus on developing treatments for stimulant use disorder. This urgent call comes as there are currently no approved therapies to address addiction to substances like cocaine, methamphetamine, or prescription stimulants, all of which have witnessed a surge in usage, often in conjunction with opioids.
In fact, Emily’s Hope reported on a new Centers for Disease Control and Prevention (CDC) report this summer that showed overdose deaths involving cocaine and psychostimulants, including methamphetamine, have been rising at an alarming rate. Opioids also played a significant role in the majority of those deaths.
From 2020 to 2021, cocaine overdose death rates increased by nearly 22%, with more than 24,000 Americans dying in 2021 from an overdose involving cocaine.
Rates of overdose deaths from psychostimulants overall have been increasing since 2010. Nearly 33,000 Americans died from an overdose involving psychostimulants in 2021, which was a 37% increase from 2020.
The FDA’s draft guidance released this week outlines the agency’s current perspective on clinical trial design and considerations spanning the drug development process. Recognizing the need for more tailored approaches, the FDA highlighted the potential for “person-centered” trials that are better equipped to detect a treatment’s effectiveness.
The FDA also indicated that certain treatments could qualify for expedited approval pathways if they address a significant unmet medical need.
“When finalized, we hope that the guidance will support the development of novel therapies that are critically needed to address treatment gaps,” said Marta Sokolowska, Ph.D., deputy center director for Substance Use and Behavioral Health in FDA’s Center for Drug Evaluation and Research.
As a strong recommendation, the agency urged trial sponsors to provide behavioral treatment to all participants involved in these studies. Additionally, the FDA expressed its openness to alternative measures for assessing treatment effectiveness beyond complete abstinence from drug use. For example, tracking days of nonuse could signify “meaningful improvement” and may offer a more practical approach to establish a treatment’s benefits.
Stimulant use disorder describes a range of symptoms associated with the use of stimulant drugs, including methamphetamine, cocaine, and amphetamines, but not including caffeine or nicotine.