FDA Approves Onyda XR, First and Only Liquid Nonstimulant for ADHD

The FDA has approved clonidine hydrochloride (Onyda XR), a once-daily, extended release, oral suspension for treatment of ADHD in pediatric patients aged 6 years and older. Clonidine hydrochloride can be used either as a monotherapy or as an adjunctive therapy to an approved central nervous system stimulant.¹

This medication is both the first and only liquid, non-stimulant ADHD medication approved in the US and the only approved non-stimulant for ADHD with a nighttime dosing option. Non-stimulant treatments are important options for people with ADHD, particularly those with inadequate responses to stimulants, those who experience adverse effects from stimulant use, and those in whom stimulant use is contraindicated.

“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, in a news release.¹ “The approval of [clonidine hydrochloride]…is a convenient option for patients needing better ADHD control.”

FDA approval “is based on adequate and well-controlled studies of clonidine hydrochloride extended-release tablets,” the company noted,¹ which are outlined in the drug's prescribing information. These studies included 2 clinical studies evaluating 256 patients over in two 8-week, placebo-controlled studies, and another study evaluating the drug in 135 pediatric patients aged 6 to 17 years over a 40-week, placebo-controlled, randomized-withdrawal study.

READ MORE: Navigating Pediatric ADHD Medication Shortages

When used as monotherapy for ADHD, the most common adverse reactions included somnolence, fatigue, irritability, nightmare, insomnia, constipation, and dry mouth. When used as an adjunct to a stimulant treatment for ADHD, the most common adverse reactions included somnolence, fatigue, decreased appetite, and dizziness.

According to the CDC,² an estimated 11.4% of children aged 3 to 17 years in the US have ever been diagnosed with ADHD, with boys more likely to be diagnosed than girls (15% vs 8%). Symptoms vary widely in severity, and the presence of comorbid conditions can increase the difficulty of diagnosis and management. Results of a national survey of parents, also shared by the CDC, suggest that in 2022, approximately 30% of children with ADHD received neither medication or behavioral treatment for their condition.

An additional challenge faced by people with ADHD is the current shortage of stimulant medications.³ The shortage, which began in 2022, is entering its second year. A combination of factors have led to this shortage, including a growing demand for stimulant medications, including among newly diagnosed adults, supply chain issues, telehealth trends, and Drug Enforcement Administration regulations around the production of controlled stimulant medications. Together, these challenges illustrate the importance of additional ADHD treatment options.

“Securing FDA approval for [clonidine hydrochloride] 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, Tris Pharma founder and CEO.¹ “Our relentless pursuit to offer a range of ADHD medicines to patients of all ages does not stop here.” The development pipeline at Tris Pharma includes TRN-110, indicated for pediatric and adult ADHD, and TRN-148, another product indicated for pediatric ADHD.⁴

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

READ MORE: Mental and Behavioral Health Resource Center

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References

1. Tris Pharma receives US FDA approval for once-daily Onyda XR (clonidine hydrochloride) extended-release oral suspension, the first-and-only liquid non-stimulant ADHD medication. Tris Pharma Inc. May 29, 2024. Accessed May 30, 2024. https://www.businesswire.com/news/home/20240529072742/en/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. Data and statistics on ADHD. CDC. May 16, 2024. Accessed May 30, 2024. https://www.cdc.gov/adhd/data/index.html

3. Casey C. ADHD medication shortage continues as diagnoses surge. CU Anschutz Medical Campus. March 18, 2024. Accessed May 30, 2024. https://news.cuanschutz.edu/news-stories/adhd-medication-shortage-continues-as-diagnoses-surge

4. Tris brand pipeline overview. Tris Pharma. Accessed May 30, 2024. https://www.trispharma.com/innovation/pipeline/