Alora Pharmaceuticals, LLC, the parent company of Vertical Pharmaceuticals, LLC, a leading pharmaceutical company committed to advancing access to high-quality therapies, announces the publication of a pivotal pharmacokinetic (PK) study in a peer-reviewed journal demonstrating bioequivalence between its extended-release formulation of Relexxii (methylphenidate hydrochloride extended-release tablets) and the reference product, Concerta® (methylphenidate hydrochloride extended-release tablets)commonly prescribed for the treatment of attention-deficit/hyperactivity disorder (ADHD).
The two replicate crossover studies compared the PK profiles of Relexxii (ODX-methylphenidate ER in the study) to the reference Product (OROS-methylphenidate ER tablet in the study) in healthy adults in the fasted state. Both trials confirmed statistical bioequivalence in key parameters, including maximum concentration (Cmax), area under the curve (AUC0–3 h, AUC3–7 h, AUC7–12 h, and AUCinf).
“This publication represents a pivotal milestone for our organization and underscores the scientific rigor behind our Relexxii formulation,” said Art Deas, Chief Executive Officer at Alora. “Demonstrating bioequivalence to the reference product not only validates the strength of our clinical and development programs but also reaffirms our commitment to bringing high-quality treatment options to patients living with ADHD.”
Ann Childress, M.D., President of the Center for Psychiatry and Behavioral Medicine and the primary author, commented: “The data demonstrate that Relexxii (ODX methylphenidate ER tablet) is bioequivalent to Concerta (OROS-methylphenidate ER tablet), including in the critical 7-12-hours postdose window. The two treatments showed a similar safety and tolerability profile in healthy adult subjects”.
Relexxii is designed using an osmotic pump delivery system to provide consistent, controlled drug release throughout the day. This innovative design mirrors the mechanism used in the reference product, enhancing confidence among prescribers and patients regarding therapeutic equivalence. Relexxii is available in 18-, 27-, 36-, 45-, 54-, 63-, and 72mg tablets, in increments of 9 mg, yielding in-between doses of 45 mg and 63 mg. Relexxii is the only branded methylphenidate HCI ER tablet with 45 mg and 63 mg strengths.
The publication was led by the company’s Vice President of Medical Affairs, Ahmad Al-Sabbagh, MD., and reflects the growing body of evidence supporting Relexxii as a reliable treatment option for individuals with ADHD.
