FDA Approves Updated Prescribing Information for Extended-Release ADHD Drug

Methylphenidate hydrochloride (Adhansia XR) was originally approved in 2019 for ADHD patients at least 6 years old.

The US Food and Drug Administration (FDA) has approved updated prescribing information for methylphenidate hydrochloride (Adhansia XR) extended-release capsules CII as a treatment for attention deficit/hyperactivity disorder (ADHD).

The agency originally approved the treatment, developed by Adlon Therapeutics, in 2019 for ADHD patients at least 6 years old.

“As a research-driven organization, we are committed to ongoing evaluation of our medicines as part of addressing the current and future needs of individuals diagnosed with ADHD,” said Julie Ducharme, BPharm, MSc, PhD, vice president and chief scientific officer, Purdue Pharma, in a statement. “We are pleased to share the news of this label update for Adhansia XR and believe inclusion of the ALC study is relevant for certain patients who may require a fast onset and longer treatment duration.”

The Drug

The treatment is the only extended-release stimulant that provides an onset of action at 1 hour with a duration of clinical effect for up to 16 hours in a single daily dose. Methylphenidate hydrochloride capsules contain identical beads formulated using the proprietary smart design MLR technology.

The Approval

The Full Prescribing Information contains a Boxed Warning because CNS stimulants do have a high potential for abuse and dependence.

The new supplemental New Drug Application (sNDA) approval was based on new data from the Adult Laboratory Classroom (ALC) study, a randomized, double-blind, parallel-group, placebo-controlled trial.

The Study

The new efficacy assessment evaluated the treatment using the Permanent Product Measure of Performance-Total (PERMP-T) scores, a skill adjusted math test, assessed during the full-day ALC study.

Post-washout, patients in the study were dose-optimized on methylphenidate hydrochloride 25-100 mg per day for 7 weeks prior to being randomized to continue their optimal dose or placebo for a 1 week double-blind treatment period that ended with a 1 full-day evaluation in an ALC.

Patients in the methylphenidate hydrochloride arm (n = 121) showed a statistically significant improvement in ADHD symptoms based on the average test scores during the full day compared to placebo (n = 118) (LS mean difference, 16.3; 95% CI, 7.6-24.9; P = 0.0003).

The improvement was observed at every individual timepoint from 1 hour to 16 hours (P <0.05).

In the dose-optimization period, 73% of the participants experienced at least 1 treatment-related adverse event (TEAE), most frequently headache (21%), decreased appetite (21%), and insomnia (16%). The majority of these events were of mild or moderate intensity with no correlation between dose level and incidence of TEAEs.