FDA Approves Tris Pharma’s Onyda XR, a Once-Daily, Extended-Release Oral Suspension for the Treatment of ADHD

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Tris Pharma announced the FDA has approved Onyda XR, a once-daily extended-release oral suspension of clonidine hydrochloride for the treatment of attention-deficit/hyperactivity disorder (ADHD) as a monotherapy, or as an adjunctive therapy to approved central nervous system (CNS) stimulant medications in pediatric patients over the age of six years. The regulatory action marks the first time that a liquid non-stimulant ADHD medication has become available in the United States. According to Tris Pharma, its LiquiXR technology provides flexibility with nighttime dosing that caters to individual patient needs and provides a smooth, extended-release profile.¹

“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, CEO, Tris Pharma, in a press release. “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.”

According to the Centers for Disease Control and Prevention (CDC), approximately 11.4% of children in the United States between 3 and 17 years of age were diagnosed with ADHD in a 2022 survey. The condition is found to be more common in male children, with Black and white children being diagnosed more often than any other race. The CDC also recommends that children under 6 years of age should enroll in behavior therapy as a first-line treatment. For older children, it is suggested to combine behavior therapy with medication.²

“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 the press release. “The approval of Onyda XR, the only liquid non-stimulant ADHD medication, with nighttime dosing that shifts the release profile, is a convenient option for patients needing better ADHD control.”

Tris warns that treatment with Onyda XR can cause decreases in blood pressure and heart rate, somnolence, sedation, and cardiac conduction abnormalities. Other common adverse reactions included fatigue, irritability, nightmare, insomnia, constipation, dry mouth, decreased appetite, and dizziness.¹

“ADHD is typically diagnosed by mental health providers or primary care providers,” reports the American Psychiatric Association. “A psychiatric evaluation will include a description of symptoms from the patient and caregivers, completion of scales and questionnaires by patient, caregivers and teachers, complete psychiatric and medical history, family history, and information regarding education, environment, and upbringing. It may also include a referral for medical evaluation to rule out other medical conditions.”³

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. Tris Pharma. May 29, 2024. Accessed May 30, 2024. https://www.trispharma.com/who-we-are/news-and-media/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. Accessed May 30, 2024. https://www.cdc.gov/adhd/data/index.html

3. What is ADHD? American Psychiatric Association. Accessed May 30, 2024. https://www.psychiatry.org/patients-families/adhd/what-is-adhd