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# Draft Guide on Developing ADHD Drugs
- URL: https://www.fdaweb.com/draft-guide-on-developing-adhd-drugs/
- Published: 2019-05-03T12:00:00.000Z
- Updated: 2026-09-15T01:24:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144024

FDA has released a draft guidance entitled [Attention Deficit Hyperactivity Disorder (ADHD): Developing Stimulant Drugs for Treatment](http://s2027422842.t.en25.com/e/er?utm%5Fcampaign=FDA%20issues%20Draft%20Guidance%20for%20Industry%3A%20Attention%20Deficit%20Hyperactivity%20Disorder&utm%5Fmedium=email&utm%5Fsource=Eloqua&s=2027422842&lid=7702&elqTrackId=124D59878CBFA28DF9DA41935D48A5D9&elq=a357c13dbada4af0b1713378a696ff27&elqaid=7897&elqat=1) that provides general recommendations to companies developing such drugs. The document explains that, because ADHD is a disorder that begins in childhood, a new drug application for any drug intended to treat ADHD should include data from adequate and well-controlled studies in pediatric patients. Additionally, it provides information on clinical trial designs and describes the types of data that would be expected to demonstrate safety and effectiveness under different approval pathways.

The recommendations in the draft identify ways to streamline stimulant development for treating ADHD. It also provides the following advice for methylphenidate and amphetamine 505(b)(2) development programs:

- Identifies ways in which drug companies can extrapolate findings from available safety and efficacy studies to reduce unnecessary burden and exposure of subjects to an active drug or placebo;
- Recommends using sparse pharmacokinetic sampling and modeling from adult data to simulate anticipated profiles in pediatric patients;
- Recommends specific criteria to determine when extrapolation is appropriate and when clinical trials are necessary to characterize the benefit-risk profile for specific patient populations (e.g., younger pediatric patients aged four to 12 years).

Additionally, the guidance identifies safety monitoring parameters to track concentration-dependent adverse reactions of special interest in stimulant drug trials, such as increased blood pressure and heart rate, insomnia, appetite suppression and delayed growth.