Pharmacokinetic Study:
RELEXXII Once-Daily Dosing Equivalency1,2
One RELEXXII (methylphenidate hydrochloride extended-release tablets) 72-mg tablet has demonstrated bioequivalence to two Concerta® (methylphenidate HCl) 36-mg tablets.2
Pharmacokinetic study of mean methylphenidate plasma concentration over time— Administration of one RELEXXII 72-mg tablet versus two Concerta® 36-mg tablets.2
Per revised FDA guidance in 2014, additional bioequivalence metrics are required to ensure that a new methylphenidate extended-release alternative is therapeutically equivalent to Concerta® tablets.3
Demonstrated Bioequivalence
- Metrics
- meets fda bioequivalent criteria
- Cmax
- AUC(0-∞)
- AUC(0-3)
- AUC(3-7)
- AUC(7-12)
A Dependable Solution for Each Patient's Unique Need
RELEXXII (methylphenidate hydrochloride extended-release tablets) is available in a range of dosing options for easy titration to achieve the necessary therapeutic range. This means you can harness an ideal dose to help patients get the therapy they need in a convenient, affordable once-daily solution.
Not actual patients. For illustrative purposes only.
Joey
Diagnosis: ADHD
Joey is newly diagnosed with ADHD and his provider started him on 18-mg of once-daily RELEXXII. With seven dosing options, and the flexibility to titrate up and down in 9-mg increments, Joey and his provider appreciate that RELEXXII can support him throughout his treatment journey.
Isabella
Diagnosis: ADHD
Isabella is currently taking 36-mg of methylphenidate. Based on recent symptoms, her provider needs to titrate her dose, but does not want to move up to 54-mg. In this case, the once-daily RELEXXII “in-between” strength of 45-mg provides a better option to titrate Isabella more gradually.
Josh
Diagnosis: ADHD
Josh is concerned about receiving tablets that vary in shape, size, and color from fill-to-fill. Josh’s provider heard his concern and prescribed once-daily RELEXXII as “Dispense as Written.” Josh is pleased to now have an expected, branded product he can reliably fill at the pharmacy.
Concerta® is a registered trademark of ALZA Corporation.
References: 1. RELEXXII (methylphenidate hydrochloride extended-release tablets) package insert. Vertical Pharmaceuticals, LLC; 2024. 2. Data on file, Osmotica Pharmaceuticals. 3. US Food and Drug Administration. Draft Guidance on Methylphenidate Hydrochloride. Revised November 2014. Accessed July 2018.
*Co-pay assistance is applicable to prescription coverage for eligible commercially insured patients. Offer void where prohibited. No income restrictions apply. Other restrictions may apply. Offer effective 04/2024. Alora Pharmaceuticals, LLC reserves the right to rescind, revoke, or amend this offer without notice. For full terms and conditions, click here.
All individuals depicted are models used for illustrative purposes only.