CLINICAL DATA

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

Line graph of mean methylphenidate plasma concentration over 36 hours: one RELEXXII 54 mg extended-release tablet vs one Concerta® 54 mg tablet in 36 healthy subjects, with closely overlapping curves
Line graph of mean methylphenidate plasma concentration over 36 hours: one RELEXXII 72 mg extended-release tablet vs two Concerta® 36 mg tablets in 60 healthy subjects, with closely overlapping curves

Meets FDA Bioequivalent Criteria (Cmax, AUC, Tmax) to Concerta®.
Graphs adapted from publication.3

Relexxii-PK72mg

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

Line graph of laboratory school teacher SKAMP combined attention ratings in children 6 to 12: methylphenidate HCl extended-release tablets vs placebo over 12 hours post-dose (reference formulation; studies not performed on RELEXXII)

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

Illustration of Osmodex technology releasing methylphenidate from an extended-release tablet

See the Technology Behind the Drug Delivery

Learn how RELEXXII’s extended-release design delivers methylphenidate throughout the day in a single tablet.

WATCH HOW RELEXXII WORKS
Healthcare provider discussing personalized ADHD treatment with a parent and child

Is RELEXXII Right for Your Patients?

Explore patient scenarios and considerations that may help guide personalized ADHD treatment decisions.

VIEW PATIENT SCENARIOS

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

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