Methamphetamine dependence

The agency is asking for comments on the draft guidelines within the next 60 days. The FDA has never had the chance to approve a stimulant use disorder treatment and so the agency has laid out its current thinking on clinical trial design, population selection and clinical endpoint selection, all in an effort to spur new interest in the space.  An unpublished draft guidance, “Stimulant Use Disorders: Developing Drugs for Treatment,” will include recommendations for clinical trials designed specifically to assess treatments for stimulant use disorders, excluding symptoms associated with caffeine or nicotine use. The guidance tackles challenges unique to the space, such as determining the appropriate populations for trials and choosing proper clinical endpoints. The FDA document expands beyond basic considerations of the drug development process, delving into approaches that have proved unsuccessful before and ways to make clinical trial design more patient-centric.  “Currently there is no FDA-approved medication for stimulant use disorder,” Marta Sokolowska, Ph.D., deputy center director for substance use and behavioral health in FDA’s Center for Drug Evaluation and Research, said in an Oct. 4 release. “When finalized, we hope that the guidance will support the development of novel therapies that are critically needed to address treatment gaps.” The FDA provides recommendations on data collection, methods to assess treatment response, subject safety and new drug application requirements.  The final version will be the agency’s first guidance about program development and trial design for drugs to treat cocaine use disorder, methamphetamine use disorder and prescription stimulant use disorder. The agency is asking for comments on the draft guidelines within the next 60 days. Some players in the stimulant use disorder treatment space include Sparian Biosciences, which has an early-stage dual sigma receptor antagonist/dopamine transporter inhibitor in development, as well as Myosin Therapeutics, which touts a preclinical small molecule modulator candidate. Both companies have received NIH funding for their work. Beyond the guidance, the FDA has also recently held workshops and public meetings to encourage the development of treatments for stimulant use disorder. 

SILVER SPRING, Md., Oct. 4, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration published a new draft guidance to assist sponsors in developing treatments for stimulant use disorders. The guidance, Stimulant Use Disorders: Developing Drugs for Treatment, when finalized, will be the first to provide the FDA's current thinking on the overall development program and clinical trial design to develop drugs and biologics to support treatment of 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. When finalized, we hope that the guidance will support the development of novel therapies that are critically needed to address treatment gaps," said Marta Sokolowska, Ph.D., deputy center director for Substance Use and Behavioral Health in FDA's Center for Drug Evaluation and Research. "The guidance is one of the actions within the agency's Overdose Prevention Framework, which includes appropriate prescribing of prescription stimulants as well as development of evidence-based treatments for stimulant use disorder." Among other things, the draft guidance contains recommendations regarding clinical trial design related to evaluating stimulant use disorder treatments. Designing clinical studies to evaluate the safety and effectiveness of stimulant use disorder treatments presents a number of unique challenges—from selecting appropriate populations for studies to determining the most appropriate clinical endpoints—that require careful review. However, there are opportunities to improve clinical trial design and develop trials that are more person-centered, which may result in increased sensitivity to detect a treatment effect, with the potential for treatment effects to be linked to meaningful long-term outcomes. The draft guidance also describes basic considerations throughout the drug development process including trial conduct, data collection, methods to assess treatment response, subject safety and new drug application requirements. For example, the guidance incorporates lessons learned about approaches that are unlikely to be successful and reflects current recommendations about approaches for treating stimulant use disorders and evaluating response to treatment. Stimulant use disorder describes a range of symptoms associated with the use of stimulant drugs, including methamphetamine, cocaine, and amphetamines, but not including caffeine or nicotine. A diagnosis of stimulant use disorder is made when a clinician identifies a pattern of use of an amphetamine-type substance, cocaine, or other stimulant that leads to clinically significant impairment or distress, including an inability to reduce or control consumption, cravings to use a stimulant, continued use of a stimulant despite it causing negative consequences, and the need to use increased amounts of a stimulant to achieve the desired effect. The agency has taken action to promote safe use and appropriate prescribing of prescription stimulants by requiring sponsors to update and standardize prescribing information for medications used to treat attention deficit/hyperactivity disorder (ADHD) and other disorders where stimulants are prescribed. Additionally, the FDA awarded the National Academies of Sciences, Engineering, and Medicine a grant to convene a workshop on the diagnosis and treatment of ADHD in adults. It has also funded several research projects to inform prevention of prescription stimulant misuse, addiction and overdose. The FDA continues to encourage the development of treatments for stimulant use disorder and novel trial designs. Over the last several years, the agency has held workshops and public meetings with patients and patient advocates, researchers, industry and other stakeholder groups to better understand the stimulant use disorder landscape and inform the FDA's understanding of the clinical context for drug review and regulatory decision making. Comments on the draft guidance are requested within 60 days to ensure the agency considers them. Additional Resources: FDA Guidances Prescription Stimulant Medications Media Contact: Lauren-Jei McCarthy 240-702-3940 Consumer Inquiries: Email or 888-INFO-FDA The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products. SOURCE U.S. Food and Drug Administration