For methamphetamine and cocaine addiction, there are no approved medications. But the Food and Drug Administration is taking steps to try to fill that glaring gap in the medical treatment of addiction.
The agency issued a draft guidance Wednesday encouraging drugmakers to develop new therapies for meth, cocaine and prescription drugs. While the nation’s current drug overdose crisis is largely driven by opioids, stimulant use has skyrocketed in recent years. A combination of opioids and stimulants, or in some cases, stimulants alone, now account for an increasing share of drug deaths.
The FDA’s move comes amid growing recognition of the threat posed by stimulants, and a continued lack of medication options available to health care providers hoping to treat stimulant addiction or individuals seeking to reduce their own drug use. The agency said: “Given the urgency of the crisis and the lack of other treatment options, certain medications may be eligible for expedited approval pathways.
“Currently, there is no FDA-approved medication for stimulant use disorder,” Marta Sokolowska, deputy director of the division of substance use within the FDA’s Center for Drug Evaluation and Research, said in a statement. “When finalized, we hope the guidance will support the development of novel therapies that are critically needed to address treatment gaps.”
Developing drugs to treat stimulant use is a daunting task. There are remarkably few medications in development to help people reduce stimulant use or achieve complete abstinence, beyond a handful of studies that emphasize the use of monoclonal antibodies to bind to methamphetamine molecules and prevent them from binding to brain receptors.
