Overdose deaths among Latinos have nearly tripled since 2011, according to a report published this month in the American Journal of Epidemiology.
Fatalities from overdoses have risen dramatically when fentanyl is mixed with other drugs, like cocaine and methamphetamine, which are more prevalent among Latinos than are heroin or prescription pain killers, according to study co-author Magdalena Cerdá, professor and director at the Center for Opioid Epidemiology and Policy at NYU Langone.
The Food and Drug Administration is encouraging drugmakers to develop treatments for stimulant use disorder, hoping to address a greater 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 emerged 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Draft guidance issued Wednesday reflects FDA’s current thinking on clinical trial design and considerations throughout the drug development process.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.
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