The new draft guidance reveals the US regulator’s current views on developing drugs and biologics for stimulant use disorders and contains recommendations on clinical trial design for assessing new treatments for stimulant use disorders
US FDA issues guidance on of stimulant use disorder drugs. (Credit: Enrique from Pixabay)
The US Food and Drug Administration (FDA) has issued a new guidance, titled Stimulant Use Disorders: Developing Drugs for Treatment, for those developing stimulant use disorder drugs.
Through the draft guidance, the US regulator reveals its current views on developing drugs and biologics for stimulant use disorders, including cocaine use disorder, methamphetamine use disorder and prescription stimulant use disorder.
The draft guidance contains recommendations on clinical trial design for assessing stimulant use disorder treatments, which presents unique challenges and needs careful review.
According to the FDA, clinical trial design can be improved by developing trials that are more person-centred, which may enhance sensitivity to detect a treatment effect.
It also depicts basic considerations in the drug development process, including trial conduct, data collection, treatment response evaluation, subject safety and regulatory requirements.
FDA Centre for Drug Evaluation and Research substance use and behavioural health deputy centre 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.”
Stimulant use disorder is a range of symptoms associated with the use of stimulant drugs, including methamphetamine, cocaine, and amphetamines, excluding caffeine or nicotine.
In diagnosing a stimulant use disorder, a clinician identifies a pattern of use of an amphetamine-type substance, cocaine, or other stimulants with clinically significant effects.
FDA said that its action promotes the safe and appropriate use of prescription stimulants.
The US health agency aims to standardise prescribing information for medications used to treat attention-deficit/hyperactivity disorder (ADHD) and other disorders that involve stimulants.
In addition, the FDA has awarded a grant to the National Academies of Sciences, Engineering, and Medicine to organise a workshop on the diagnosis and treatment of ADHD in adults.
The agency also funded several research projects to help prevent misuse, addiction and overdose of prescription stimulants.