FDA urges development of cocaine and meth addiction treatments
Add Axios as your preferred source to
see more of our stories on Google.
Illustration: Sarah Grillo/Axios
The Food and Drug Administration is encouraging drugmakers to develop treatments for stimulant use disorder, hoping to address a major gap in the addiction crisis response.
Driving the news: There aren't any approved treatments to help address addiction to cocaine, meth or prescription stimulants, whose use has surged in recent years — often in combination with opioids.
- Draft guidance issued Wednesday reflects FDA's current thinking on clinical trial design and considerations throughout the drug development process. FDA noted there are opportunities for "more person-centered" trials with greater sensitivity to detecting a treatment's effect.
- The agency acknowledged there are "a number of uncertainties" about the best approaches for treating stimulant use disorder or evaluating responses to treatments.
- It also said there is such a wide range of symptoms that it could be difficult to identify which medications are effective for cocaine or meth — or stimulant use more broadly.
Among other considerations, the agency recommended clinical trial sponsors separately study people who use cocaine, meth and prescription stimulants to improve the odds of developing successful treatments.
- FDA said it's open to other measures of a treatment's effectiveness besides abstinence from drug use.
- For instance, measuring days of nonuse may reflect "meaningful improvement" and may be more practical than other ways of establishing benefit, the guidance reads.
- It also said some treatments may be eligible for FDA's expedited approval pathways for addressing a major unmet medical need.
- FDA "strongly" recommended that trial sponsors provide behavioral treatment to all trial participants.
What they're saying: "When finalized, we hope that the guidance will support the development of novel therapies that are critically needed to address treatment gaps," Marta Sokolowska, deputy director for substance use and behavioral health in FDA's Center for Drug Evaluation and Research, said in a statement.
