FDA Approves Tris Pharma's ONYDA XR, First Liquid Non-Stimulant ADHD Medication

Tris Pharma, Inc., a biopharmaceutical company specializing in disorders such as attention deficit hyperactivity disorder (ADHD), pain, addiction, and neurological disorders, has announced that the U.S. Food and Drug Administration (FDA) has approved ONYDA™ XR (clonidine hydrochloride). This once-a-day, extended-release oral suspension, designed for nighttime administration, is intended to treat ADHD either as a standalone therapy or alongside approved central nervous system (CNS) stimulant medications in children aged six years and older.

ONYDA XR stands out as the first non-stimulant ADHD medication in Tris Pharma’s collection and the only liquid non-stimulant ADHD medication approved in the United States with nighttime dosing. Non-stimulant therapies offer vital options for patients who either do not adequately respond to stimulant medications or experience adverse side effects from them. Increasingly, these therapies are recognized as effective alternatives to stimulant treatments. ONYDA XR is expected to become available in pharmacies in the latter half of 2024.

Dr. Ann Childress emphasized the need for diverse therapeutic options to cater to individual patient needs, noting that ONYDA XR provides a convenient solution for better ADHD management due to its unique nighttime dosing and liquid form. This innovation allows for a controlled release profile, enhancing patient comfort and compliance.

Tris Pharma utilized its proprietary LiquiXR® technology to develop ONYDA XR. This technology ensures a smooth, extended-release medication, which can be used alone or in combination with stimulant treatments to manage ADHD. This addition to Tris' extensive ADHD therapy portfolio aims to enhance patient care. The company’s offerings include both liquid and solid forms suitable for children and adults. Tris is also expanding its pipeline of ADHD medications, potentially offering substantial benefits to those with the disorder.

Ketan Mehta, Tris Pharma's Founder and CEO, highlighted the FDA approval of ONYDA XR as a significant milestone and a testament to the company's dedication to improving outcomes for ADHD patients. He reaffirmed Tris Pharma's commitment to developing a comprehensive range of ADHD treatments for patients of all ages and expressed enthusiasm for future expansions to their portfolio.

The FDA approval of ONYDA XR is supported by comprehensive and well-controlled studies involving clonidine hydrochloride extended-release tablets.

In terms of safety, ONYDA XR is contraindicated for patients with a history of hypersensitivity reactions to clonidine. The medication may cause dose-related decreases in blood pressure and heart rate, necessitating slow titration and frequent monitoring of vital signs, especially in patients at risk for hypotension, heart block, bradycardia, syncope, and various cardiovascular and renal diseases.

Common adverse reactions associated with ONYDA XR include somnolence, fatigue, irritability, nightmares, insomnia, constipation, and dry mouth when used as monotherapy. When used alongside psychostimulants, common reactions include somnolence, fatigue, decreased appetite, and dizziness.

Drug interactions are a key consideration, as clonidine can enhance the CNS-depressive effects of alcohol and other sedating drugs. It can also counteract the effects of tricyclic antidepressants, which may lead to increased blood pressure. Additionally, caution is advised when ONYDA XR is used with drugs affecting sinus node function or AV nodal conduction and antihypertensive drugs.

For specific populations, the effects of renal impairment on the pharmacokinetics of clonidine in pediatric patients have not been thoroughly studied. Dosage adjustments and careful monitoring are recommended. For pregnant women, existing literature does not indicate a significant risk of major birth defects or adverse outcomes, but healthcare providers are encouraged to register patients in the National Pregnancy Registry for Psychiatric Medications to monitor pregnancy outcomes. For lactating women, the benefits of breastfeeding should be weighed against the mother's need for ONYDA XR and potential adverse effects on the breastfed child.

Tris Pharma continues to prioritize innovation and improvement in ADHD treatment options, reflecting their ongoing commitment to patient care and therapeutic advancements.