Recent Study Establishes Bioequivalence of Relexxii® and Concerta® for ADHD Treatment

New Study Validates Bioequivalence of Relexxii® and Concerta®

On August 19, 2025, Alora Pharmaceuticals, LLC, announced pivotal findings regarding its extended-release ADHD medication, Relexxii (methylphenidate hydrochloride). A recent pharmacokinetic (PK) study published in a peer-reviewed journal verified that Relexxii exhibits bioequivalence compared to the established treatment, Concerta (methylphenidate hydrochloride). This confirmation is significant as both drugs are widely used to treat attention-deficit/hyperactivity disorder (ADHD).

The study involved two separate crossover trials with healthy adults who were administered both medications under fasting conditions. The results highlighted that the pharmacokinetic profiles of Relexxii and Concerta were closely aligned, especially in vital parameters such as maximum concentration (Cmax) and the area under the curve (AUC) across different time frames.

Art Deas, CEO of Alora Pharmaceuticals, emphasized the importance of these results, stating, "This publication signifies an essential achievement for our organization and highlights the scientific accuracy behind our Relexxii formulation." By demonstrating bioequivalence, Alora confirms the reliability of its clinical and development efforts, further underlining its commitment to providing quality treatment solutions for those coping with ADHD.

Dr. Ann Childress, President of the Center for Psychiatry and Behavioral Medicine and also the primary author of the study, provided insights on the findings, stating, "The data indicate that Relexxii is bioequivalent to Concerta, encompassing the critical post-dose window of 7-12 hours. Both medications exhibited similar safety and tolerability profiles in the study's participants."

Relexxii is formulated with a unique osmotic pump delivery system aimed at offering a controlled and consistent release of the medication throughout the day. This innovative approach closely mimics the functionality of Concerta, instilling confidence in both prescribers and patients concerning the therapeutic equivalence between the two options. Relexxii is available in a variety of strengths including 18 mg, 27 mg, 36 mg, 45 mg, 54 mg, 63 mg, and 72 mg, with the flexibility to accommodate doses that range from 45 mg to 63 mg. Notably, it is the only branded methylphenidate hydrochloride extended-release tablet that offers these specific strength increments.

The publication derived from the expertise of Ahmad Al-Sabbagh, MD, Vice President of Medical Affairs at Alora, showcases the mounting evidence favoring Relexxii as a viable and trustworthy treatment for individuals diagnosed with ADHD.

Alora Pharmaceuticals is recognized not only for its innovative products but also for its strong commitment to addressing the pressing nationwide supply shortages of ADHD treatments. The company, headquartered in Alpharetta, Georgia, oversees multiple pharmaceutical entities, establishing itself as a substantial player within the healthcare market.

For more detailed information about Alora Pharmaceuticals and their work in tackling ADHD treatment shortages, please visit their website at www.alorapharma.com. It's imperative to note that Relexxii® is a registered trademark of Vertical Pharmaceuticals LLC, while Concerta® is a trademark of ALZA Corporation.