Guidance on Developing Treatments for Stimulant Use Disorders

Key Takeaways

• FDA has not yet approved any medications for stimulant use disorders.
• The guidance addresses treatment for moderate to severe stimulant use disorders.
• It emphasizes the importance of clinical trial design and efficacy measurement.
• FDA encourages ongoing dialogue with sponsors during drug development.

What does this document cover?

The guidance provides FDA's recommendations for the clinical development of drugs for stimulant use disorders, including trial design, efficacy measures, and benefit-risk considerations.

Why it matters for pharma teams

Understanding FDA's guidance is essential for pharmaceutical companies to navigate the regulatory landscape and successfully develop treatments for stimulant use disorders, ultimately impacting public health.

Frequently Asked Questions

What is the focus of this guidance?

This guidance focuses on assisting sponsors in the clinical development of drugs for the treatment of stimulant use disorders, specifically addressing recommendations for clinical trial designs to support indications for moderate to severe stimulant use disorders.

Does this guidance address all stimulant-related conditions?

No, this guidance does not address the treatment of intoxication, poisoning, or withdrawal from stimulants.

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