Onyda XR: The First and Only Liquid Nonstimulant ADHD Medication

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Onyda XR is the first and only liquid nonstimulant ADHD medication approved in the US and the only approved nonstimulant ADHD medication with nighttime dosing.

ADHD

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The US Food and Drug Administration (FDA) has approved Tris Pharma’s Onyda XR (clonidine hydrochloride) for the treatment of attention-deficit/hyperactivity disorder (ADHD) as a monotherapy or as an adjunctive therapy to approved central nervous system stimulant medications in pediatric patients 6 years and older. Onyda XR, a once-a-day extended-release oral suspension with nighttime dosing, is the first and only liquid nonstimulant ADHD medication approved in the US and the only approved nonstimulant ADHD medication with nighttime dosing.1

“People with ADHD require a range of therapeutic options that are designed for their individual needs, because not every medication or type of therapy works for every patient,” said Ann Childress, MD. “The approval of Onyda XR, the only liquid nonstimulant ADHD medication, with nighttime dosing that shifts the release profile, is a convenient option for patients needing better ADHD control.”

Onyda XR was developed by Tris Pharma using the flexibility of its proprietary LiquiXR® technology, ensuring a smooth, extended-release profile that physicians can use to treat ADHD patients either alone or in combination with stimulant therapy.

“Securing FDA approval for Onyda XR is not just an important milestone, but a testament to our unwavering commitment to innovating and improving outcomes for this patient population,” said Ketan Mehta, founder and CEO of Tris Pharma. “Our relentless pursuit to offer a range of ADHD medicines to patients of all ages does not stop here, and we look forward to continuing to expand our portfolio in other ADHD indications.”

Tris Pharma is expanding its ADHD offerings with a pipeline of new medications that could have a substantial impact for those with the disorder, including TRN-110 for pediatric and adult ADHD, as well as TRN-148 for pediatric ADHD.2

According to Onyda XR prescribing information, the most common adverse reactions with use as monotherapy include somnolence, fatigue, irritability, nightmare, insomnia, constipation, and dry mouth.The most common adverse reactions with use as an adjunct therapy to psychostimulant in ADHD include somnolence, fatigue, decreased appetite, dizziness.3

The FDA approval of Onyda XR is based on studies of clonidine hydrochloride extended-release tablets. Investigators evaluated clonidine hydrochloride extended-release for ADHD using a total of 256 patients in 2 separate 8-week placebo-controlled clinical studies. A third clinical study evaluating clonidine hydrochloride extended-release for ADHD used 135 pediatric patients aged 6 to 17 years in a 40-week placebo-controlled randomized-withdrawal study.

The first study was a short-term, multi-center, randomized, double-blind, placebo-controlled study of 2 fixed doses (0.2 mg/day or 0.4 mg/day) of clonidine hydrochloride extended-release in pediatric patients 6 to 17 years of age who met DSM-IV criteria for ADHD hyperactive or combined inattentive/hyperactive subtypes.

The second study was a short-term, randomized, double-blind, placebo-controlled study of a flexible dose of clonidine hydrochloride extended-release as adjunctive therapy to a psychostimulant in pediatric patients aged 6 to 17 years who met DSM-IV criteria for ADHD hyperactive or combined inattentive/hyperactive subtypes. Clonidine hydrochloride extended-release was initiated at 0.1 mg/day and titrated up to 0.4 mg/day over a 3-week period. Most patients treated with clonidine hydrochloride extended-release (75.5%) were escalated to the maximum dose of 0.4 mg/day.3

Onyda XR is expected to be available in pharmacies in the second half of 2024.

References

1. Tris Pharma receives U.S. FDA approval for once-daily ONYDA XR (clonidine hydrochloride) extended-release oral suspension, the first-and-only liquid non-stimulant ADHD medication. News release. BioSpace. May 29, 2024. https://www.biospace.com/article/releases/tris-pharma-receives-u-s-fda-approval-for-once-daily-onyda-xr-clonidine-hydrochloride-extended-release-oral-suspension-the-first-and-only-liquid-non-stimulant-adhd-medication/

2. Pipeline: Leveraging unique technology to drive innovative drug development. Accessed May 29, 2024. https://www.trispharma.com/innovation/pipeline/

3. Highlights of prescribing information: Onyda XR. FDA. Accessed May 29, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217645s000lbl.pdf

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