ADVERTISEMENT
Once-Daily Methylphenidate Hydrochloride ER Now Available for Pediatric ADHD
Clinicians now have a new treatment option available for pediatric attention-deficit/hyperactivity disorder (ADHD): methylphenidate hydrochloride extended-release tablets (Relexxii).
Manufactured by Vertical Pharmaceuticals, a subsidiary of Alora Pharmaceuticals, Relexxii is a once-daily central nervous system stimulant indicated for the treatment of ADHD in adults up to age 65 and pediatric patients 6 years and older.
Notably, Relexxii is available in “in-between” strengths, with the option to increase or decrease the prescription in 9-mg increments. Alora’s press release also highlighted the drugs “Osmodex Drug Delivery Technology,” which releases the medication in patients’ systems “at a controlled rate throughout the day.”
>>QUIZ: Does high-frequency transcranial random noise stimulation improve ADHD symptoms?
Alora reports that in a study of 60 healthy volunteers, a once-daily dosing of Relexxii at 72-mg “demonstrated bioequivalence” to twice daily dosing of methylphenidate HCl (Concerta) 36-mg tablets. This data has not been peer-reviewed, and is on file with Osmotica Pharmaceuticals US, LLC.
"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,” said Harold Deas, CEO of Alora. “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."
Relexxi is a Schedule II controlled substance, and includes a boxed warning regarding substance use disorder. Sudden death is also a risk in patients with serious cardiac disease.
References
