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USFDA Guidance: Developing Drugs for Treatment for Stimulant Use Disorders

A draft guidance "Stimulant Use Disorders: Developing Drugs for Treatment" was published yesterday (05 October, 2023) by the US Food and Drug Administration Center for Drug Evaluation and Research (CDER) to help sponsors develop treatments for stimulant use disorders.

In this guidance, the Food and Drug Administration (FDA) provides recommendations on the overall development program and clinical trial design for developing drugs with indications for treatment of moderate to severe cocaine use disorder, moderate to severe methamphetamine use disorder, or moderate to severe prescription stimulant use disorder, as well as the overall development program and clinical trial design.

Stimulant Use Disorder, defined as “a pattern of amphetamine-type substance, cocaine, or other stimulant use leading to clinically significant impairment or distress,” ranging from mild to severe and the definition lists various symptoms of impairment or distress, but notably, it does not include any criteria related to amount or frequency of stimulant use.

In addition, FDA encourages the development of stimulant use disorder treatments as well as novel trial designs, and such programs may be eligible for one or more of FDA's expedited programs. FDA encourages early discussion of drugs that could treat stimulant use disorder and may be eligible for expedited programs.

To know more in detail about the Early Phase Development Considerations, Efficacy Trial Considerations, endpoints etc click this LINK.

Also FDA Launched Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program to help further accelerate the development of novel drug and biological products for rare diseases.


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