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.
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.
- 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.
- Adhansia XR [package insert]. Wilson, NC: Purdue Pharmaceuticals L.P.; 2021.