FDA Releases Draft Guidance for Developing Treatments for Stimulant Use Disorders
The US Food and Drug Administration (FDA) has recently released a draft guidance aimed at assisting sponsors in developing treatments for stimulant use disorders. The guidance, titled “Stimulant Use Disorders: Developing Drugs for Treatment,” aims to bridge the treatment gap for moderate to severe cocaine use disorder, methamphetamine use disorder, and prescription stimulant use disorder.
Currently, there is no FDA-approved medication for stimulant use disorder. The draft guidance aims to support the development of novel therapies by providing recommendations for clinical trial design and addressing the unique challenges associated with evaluating stimulant use disorder treatments.
One of the key highlights of the guidance is the emphasis on person-centered clinical trial design. The FDA believes that this approach will increase sensitivity in detecting treatment effects and achieving meaningful long-term outcomes.
The draft guidance also covers considerations throughout the drug development process, including trial conduct, data collection, treatment response assessment, subject safety, and new drug application requirements.
Stimulant use disorder encompasses symptoms related to the use of stimulant drugs such as methamphetamine, cocaine, and amphetamines. However, the guidance excludes caffeine and nicotine as they are not considered within the scope of stimulant use disorder.
In recent years, the FDA has been proactive in promoting safe use and appropriate prescribing of prescription stimulants. This includes updating prescribing information for medications used for attention deficit/hyperactivity disorder (ADHD). The FDA has also awarded a grant to the National Academies of Sciences, Engineering, and Medicine to hold a workshop on the diagnosis and treatment of ADHD in adults.
In addition, the FDA has funded various research projects to inform prevention strategies against prescription stimulant misuse, addiction, and overdose. The agency acknowledges the importance of stakeholder collaboration and engagement. They have held workshops and public meetings to gather insights on stimulant use disorder to shape their understanding of the clinical context for regulatory decision making.
The FDA is encouraging stakeholders to provide comments on the draft guidance within a 60-day period. This feedback will be considered by the FDA in the finalization process, ensuring that the guidance incorporates diverse perspectives and expertise.
Overall, the release of the draft guidance signals the FDA’s commitment to addressing the treatment gap for stimulant use disorders. By providing clear recommendations for drug development and clinical trial design, the FDA aims to support the development of safe and effective treatments for individuals struggling with stimulant use disorders.
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