The Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Adhansia XR® (methylphenidate HCl extended-release capsules) to include additional clinical data in adult patients with attention deficit hyperactivity disorder (ADHD). 

Adhansia XR is indicated for the treatment of ADHD in patients 6 years and older. The sNDA approval was based on data from a randomized, double-blind, placebo-controlled, dose optimized, phase 3 Adult Laboratory Classroom (ALC) study (ClinicalTrials.gov Identifier: NCT03618030), which assessed the efficacy and safety of Adhansia XR in 239 adults diagnosed with ADHD. In an open-label phase, patients were titrated to an optimal dose of Adhansia XR (25 to 100mg/day) for up to 7 weeks and then randomly assigned to continue their optimal dose of Adhansia XR (n=121) or placebo (n=118) for a 1-week double-blind treatment period.

At the end of the double-blind treatment period, patients were assessed with a 1 full day evaluation in an ALC session using the Permanent Product Measure of Performance Total (PERMP-T) score. The primary endpoint was the mean PERMP-T scores across all timepoints at pre-dose and at 0.5, 1, 2, 4, 6, 7.5, 9, 11, 13, 14, 15, and 16 hours post dose on the ALC day. 

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Results showed that treatment with Adhansia XR met the primary endpoint achieving a statistically significant improvement in ADHD symptoms during the full day ALC visit compared with placebo (least squares [LS] mean difference 16.3; 95% CI, 7.6-24.9; P =.0003). Adhansia XR demonstrated statistically significant improvements over placebo at 1, 2, 4, 6, 7.5, 9, 11, 13, 14, 15, and 16 hours post dose (all P <.05). The most frequently reported treatment-related adverse events were headache (21%), decreased appetite (21%), and insomnia (16%); most were mild or moderate in intensity.

Adhansia XR is supplied in 25mg, 35mg, 45mg, 55mg, 70mg, and 85mg extended-release capsules; each bottle contains 30 capsules.

References

  1. FDA approves supplemental New Drug Application for Adhansia XR® (methylphenidate HCl) extended-release capsules CII. [press release]. Stamford, CT: Adlon Therapeutics L.P.; July 1, 2021. 
  2. Adhansia XR [package insert]. Wilson, NC: Purdue Pharmaceuticals L.P.; 2021.

This article originally appeared on MPR

Topics:

Attention-Deficit/Hyperactivity Disorder general practice Mood Disorders