FDA Approves Tris Pharma’s Onyda XR, First Liquid Non-Stimulant ADHD Medication for Pediatric Patients ###

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1. FDA Approval: The FDA approved Tris Pharma's Onyda XR, a once-daily extended-release oral suspension of clonidine hydrochloride, for the treatment of ADHD in pediatric patients aged 6 and older.
2. First Liquid Non-Stimulant ADHD Medication: Onyda XR is the first and only liquid non-stimulant ADHD medication approved in the United States, offering an alternative for patients who do not respond well to stimulants or experience negative side effects.
3. Nighttime Dosing: The medication features nighttime dosing, which shifts the release profile to provide a smooth, extended-release profile.
4. LiquiXR Technology: Tris Pharma used its proprietary LiquiXR technology to develop Onyda XR, allowing for a consistent therapeutic effect throughout the night.
5. Indication: Onyda XR is indicated for the treatment of ADHD as monotherapy or as adjunctive therapy to approved CNS stimulant medications in pediatric patients 6 years and older.
6. Availability: The medication is expected to be available in pharmacies in the second half of 2024.
7. Side Effects: Common side effects include decreases in blood pressure and heart rate, somnolence, sedation, and cardiac conduction abnormalities, as well as fatigue, irritability, nightmares, insomnia, constipation, dry mouth, decreased appetite, and dizziness.
8. Tris Pharma's Commitment: The company continues to expand its portfolio of ADHD therapies, aiming to provide a range of options for patients with individual needs.