Alora Pharmaceuticals, LLC, the parent company of Vertical Pharmaceuticals, LLC, announced today the commercial availability of Relexxii® (methylphenidate hydrochloride extended-release tablets). Relexxii is a once-daily central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults (up to the age of 65 years) and in pediatric patients 6 years of age and older.1 With the introduction of Relexxii, patients and health care professionals will have an additional branded ADHD treatment option from which to choose.
Once-daily Relexxii is now widely available in flexible dosing options that support a more tailored treatment approach throughout the ADHD treatment journey: 18-mg, 27-mg, 36-mg, 45-mg, 54-mg, 63-mg, and 72-mg. This line of once-daily strengths has been specifically designed to support targeted titration to help achieve the lowest effective dose and to help mitigate the need for multiple daily pills. Once-daily Relexxii strengths are offered in 9-mg increments, yielding two "in-between" doses of 45-mg and 63-mg.
Relexxii once-daily dosing is made possible by Alora Pharmaceutical’s Osmodex® Drug Delivery Technology, which allows the medication to be released at a controlled rate throughout the day. With the immediate-release drug layer dissolving within one hour of administration, patients get the medicine they need quickly — and for up to 24 hours — with each daily dose.
In a study of 60 healthy volunteers, once-daily dosing of Relexxii 72-mg demonstrated bioequivalence to twice daily dosing of Concerta® (methylphenidate HCI) 36-mg tablets.²
"Alora Pharmaceuticals recognizes the importance of reliability when it comes to ADHD medications. Our mission of manufacturing supply to address the nationwide shortage is unwavering. With Relexxii, we can offer the consistency of a branded treatment for individuals affected by ADHD. Alora Pharmaceuticals remains committed to ensuring that patients have access to affordable medications that they need", stated Harold (Art) Deas, CEO of Alora Pharmaceuticals, LLC.
To learn more about Relexxii or to find patient support resources, please visit www.relexxii.com. For Full Prescribing Information, including BOXED WARNING, please visit www.relexxii.com/pi.
About Alora Pharmaceuticals, LLC
Alora Pharmaceuticals, LLC is the parent company of six specialty pharmaceutical and pharmaceutical manufacturing companies. Headquartered in Alpharetta, GA, Alora is the parent company of the following organizations that comprise the Alora Family of Companies: Avion Pharmaceuticals, Acella Pharmaceuticals, Osmotica Pharmaceuticals, Sovereign Pharmaceuticals, Trigen Laboratories, and Vertical Pharmaceuticals.
For media inquiries or for more information about Alora’s efforts to address the nationwide ADHD treatment supply shortage, please contact Alora Pharmaceuticals, LLC: 1880 McFarland Parkway, Suite 110, Alpharetta, GA 30005; 1-678-325-5189.
Relexxii® is a registered trademark of Vertical Pharmaceuticals, LLC.
Osmodex® is a registered trademark of Acella Holdings, LLC.
Concerta® is a registered trademark of ALZA Corporation.
References:
1. Relexxii (methylphenidate hydrochloride extended-release tablets) package insert. Vertical Pharmaceuticals, LLC; 2023.
2. Data on file, Osmotica Pharmaceuticals US LLC.