The FDA released a draft guidance for sponsors of stimulant drugs for treating attention deficit hyperactivity disorder (ADHD) with recommendations for clinical trials and new drug applications.
The agency recommends that sponsors of methylphenidate and amphetamine products can include data from pediatric studies in their new drug applications—even for adult indications.
Two positive pediatric studies and a single trial in adult patients can support adult indications, the agency says, because there is enough similarity between the pathophysiology, disease characteristics, and treatment outcomes for children and adults.
The NDAs should include data adequate to assess the drug’s safety and effectiveness for patients four years of age and up. To generate evidence of effectiveness, sponsors should conduct one study in adolescent patients 13 to 17 years of age and one in patients aged four to 12. For these studies, the drug’s duration should be less than 12 hours, the pharmacokinetic profile should be similar across the age groups, and no safety concerns should be present that would prevent the studies.
Sponsors can develop formulations using the same active moiety with the aim of creating drug-specific release features to affect the pharmacokinetic profile and the onset or duration of effect, the agency says.
