Onyda XR: New FDA-Approved Liquid Non-Stimulant for ADHD

October 17, 2024

Onyda XR (clonidine hydrochloride), the first and only liquid non-stimulant ADHD medication approved in the U.S., and the only such medication with nighttime dosing, became available nationwide for the treatment of attention deficit hyperactivity disorder (ADHD) on October 1. ¹

The U.S. Food and Drug Administration (FDA) approved Onyda XR on May 24 as a monotherapy ADHD treatment or as an adjunctive therapy to approved central nervous system (CNS) stimulant medications in pediatric patients six years and older.

Tris Pharma developed Onyda XR with its proprietary LiquiXR® technology, which converts immediate-release drugs into extended-release formulations for once-daily dosing. Onyda XR is considered a centrally acting alpha2-adrenergic agonist medication that belongs to the same class of drugs as Guanfacine (Intuniv) and clonidine (Kapvay).

Patients with ADHD who experience adverse side effects from stimulants or who respond poorly to stimulant medications may find symptom relief in a non-stimulant medication. A systematic review and meta-analysis published in May by Neuroscience & Biobehavioral Reviews reported that non-stimulant medication is nearly as effective as stimulant medication at improving executive function in children, adolescents, and adults with ADHD. ²

Combination Therapy for ADHD

In addition, clinicians may prescribe Onyda XR along with a stimulant to treat ADHD symptoms. Combination therapy is becoming an increasingly popular option for patients who need longer durations of drug coverage than a stimulant dose can provide on its own or who hope to avoid common stimulant side effects.

“Most of the medicines we use for ADHD are safe in combination with other medications,” said Timothy E. Wilens, M.D., chief of child and adolescent psychiatry and co-director of the Center for Addiction Medicine at Massachusetts General Hospital, during the ADDitude webinar “Combination Therapy: Medication Strategies for Hard-to-Treat Complex ADHD.” “Certain combinations, such as stimulants plus clonidine or guanfacine, are FDA approved, and they wouldn’t be unless they were deemed effective and safe.”

Guanfacine ER (Intuniv) and clonidine ER (Kapvay), received FDA approval for the treatment of ADHD in patients 6 to 17 years old as monotherapy and as adjunctive therapy to stimulant medications in 2009 and 2010, respectively.

If a stimulant does not address symptoms at standard dosages, “it usually makes more sense to treat remaining symptoms with a second medication,” said Oren Mason, M.D., a physician at Attention MD in Grand Rapids, Michigan.

“Most adult patients in my practice who take extended-release stimulants need average to high dosages to achieve optimal symptom reduction,” Mason said. “They typically report 8 to 10 hours of medication benefit, and most require short-acting supplements to treat their evening symptoms. In contrast, most patients on combination therapy take low- to moderate stimulant dosages and report a duration of benefits of more than 12 hours.”

Mason said he finds that many adult patients using combination therapy decrease their stimulant dosages and experience fewer side effects than do patients taking only stimulants. “Waking up was less torturous, and getting ready for school was smoother,” he said. “Family life was better, without the meltdowns that many families accept as ‘normal’ as stimulants wear off.”

Anthony Rostain, M.D., M.A., professor of psychiatry and pediatrics at the Perelman School of Medicine at the University of Pennsylvania, recommends that clinicians consider several factors before prescribing combination therapy.

“The important thing to keep in mind if you’re combining agents,” he said, “is to be sure that the patient understands how to use each one and how to dose each one. They need to understand the inherent challenges they’re going to face, and make sure you’re paying attention to the side effects that might emerge from the combination of stimulant and non-stimulant.”

The FDA based its approval for Onyda XR on studies of clonidine hydrochloride extended-release tablets, including two 8-week, placebo-controlled trials evaluating 256 patients, as well as a 40-week, placebo-controlled, randomized-withdrawal study evaluating the drug in 135 pediatric patients aged 6 to 17 years. ³, ⁴

According to Onyda XR prescribing information, the most common adverse reactions with the medication’s use as monotherapy include somnolence, fatigue, irritability, nightmares, insomnia, constipation, and dry mouth. The most common adverse reactions with its use as an adjunct therapy include somnolence, fatigue, decreased appetite, and dizziness. ⁵

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