See the Technology Behind the Drug Delivery
Learn how RELEXXII’s extended-release design delivers methylphenidate throughout the day in a single tablet.
Pharmacokinetic & bioequivalence studies of extended-release methylphenidate1,2
Mean Methylphenidate Plasma Concentrations Over Time
RELEXXII has demonstrated bioequivalence to Concerta, including in the critical 7-12 hour post-dose window.1-3
Meets FDA Bioequivalent Criteria (Cmax, AUC, Tmax) to
Concerta®.
Graphs adapted from publication.3
The bioavailability of RELEXXII 54 mg and 72 mg resulted in plasma concentrations at or above 5 ng/mL between 1 and 15 hours post-dose.1,4
View the Open-Access Clinical Publication
Pharmacokinetics and Bioequivalence of a Novel Extended-Release Formulation of Methylphenidate Hydrochloride for Attention-Deficit/Hyperactivity Disorder3
RELEXXII offers patients reliable, all-day ADHD symptom control with just one extended-release tablet
SKAMP ratings demonstrate symptom control up to 12 hours
Help Improve Classroom Attention and Behavior with RELEXXII
Combined results from two studies demonstrated statistically significant improvements in attention and behavior that were maintained through 12 hours after dosing.1
In Studies 1 and 2, symptoms of ADHD were evaluated by laboratory school teachers using the Swanson, Kotkin, Agler, M-Fynn, and Pelham (SKAMP) laboratory school rating scale.1
Study Design:
Three double-blind, active and placebo controlled studies were conducted in 416 pediatric patients 6 to 12 years. The controlled studies compared methylphenidate hydrochloride extended-release tablets given once daily (18 mg, 36 mg, or 54 mg), methylphenidate given three times daily over 12 hours (15 mg, 30 mg, or 45 mg total daily dose), and placebo in two single-center, 3-week crossover studies (Studies 1 and 2).1
Laboratory School Teacher SKAMP Ratings:
Mean (SEM)
of Combined Attention (Studies 1 and 2)1
Based on FDA bioequivalence to another formulation of methylphenidate hydrochloride extended-release tablets. Studies not performed on RELEXXII.
Graph adapted from the PI.
Laboratory School Teacher SKAMP Ratings:
Mean (SEM) of
Combined Attention (Studies 1 and 2)1
Is RELEXXII Right for Your Patients?
Explore patient scenarios and considerations that may help guide personalized ADHD treatment decisions.
Concerta® is a registered trademark of ALZA Corporation.
References: 1. RELEXXII package insert. Vertical Pharmaceuticals, LLC. 2. Data on file, Osmotica Pharmaceuticals. 3. Childress AC, et al. Clin Pharmacol Drug Dev. 2025;0(0):1-7. 4. Spencer TJ, et al. Am J Psychiatry. 2006;163(3):387-395.
All individuals depicted are models used for illustrative purposes only.
ADHD=attention deficit hyperactivity disorder