There aren’t any FDA-approved medications for cocaine, methamphetamine and prescription stimulants. The agency is looking to fill that void.
An agency draft guidance lays out recommendations on the development of clinical trials for drugs aimed at treating moderate to severe cocaine use disorder, methamphetamine use disorder or prescription stimulant use disorder.
“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, deputy center director for Substance Use and Behavioral Health under the Food and Drug Administration (FDA).
Some of the recommendations:
- Study people with different substance abuse disorders separately.
- Clinical trials should be randomized, double-blind and placebo-controlled.
- Progress shouldn’t solely be measured with urine toxicology testing, with the agency saying it doesn’t account for “how the subject feels, functions, or survives.”
Abuse of opioids, which are depressants, can be treated medically through approved drugs like buprenorphine, methadone and naltrexone.
With no analogous options available for stimulant use disorder, most treatments tend to be therapy-based. Some medications may be given to patients with stimulant use disorder, but those would be considered off-label use.
Overdose deaths involving stimulant substances have been on the rise. From 2012 through 2019, the rate of cocaine-involved overdose deaths more than tripled, according to the National Center for Health Statistics.
In 2021, cocaine was involved in almost 23 percent of overdose deaths while fatal overdoses related to other stimulants like ecstasy, methamphetamine and prescribed medications jumped by 37 percent from the previous year. The FDA will be accepting public comments on this guidance until Dec. 4.
