The US Food and Drug Administration (FDA) has issued a draft guidance to aid sponsors in developing biologics and drugs for stimulant use disorders.
Dubbed Stimulant Use Disorders: Developing Drugs for Treatment, the guidance will offer the regulator’s directives in the complete drug development programme.
The guidance outlines insights into designing clinical trials of drugs and therapies for moderate to severe cocaine, methamphetamine and prescription stimulant use disorders.
These trials designed to assess the effectiveness and safety of treatments for stimulant use disorder should prioritise a person-centric approach to precisely detect a drug effect.
The strategy, which includes the selection of apt trial subjects and endpoints, will aid in developing drugs that have durable outcomes in patients.
Recommendations on treatment development methods such as conduct of clinical trials, data gathering and ways to evaluate drug response are listed in the guidance.
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The document also comprises considerations on subject safety and requirements for filing new drug applications.
FDA Center for Drug Evaluation and Research Substance Use and Behavioral Health deputy center director Marta Sokolowska said: “Currently there is no FDA-approved medication for stimulant use disorder. When finalised, we hope that the guidance will support the development of novel therapies that are critically needed to address treatment gaps.
“The guidance is one of the actions within the agency’s Overdose Prevention Framework, which includes appropriate prescribing of prescription stimulants as well as the development of evidence-based treatments for stimulant use disorder.”