Tris Pharma — Onyda Xr FDA Review (NDA217645, ORIG 1, 2024)
Tris Pharma · 2024 · FDA Review (openFDA)
Report summary
Tris Pharma seeks FDA approval for Onyda XR (clonidine hydrochloride extended-release oral suspension) to treat ADHD in pediatric patients aged 6 and older, as monotherapy or adjunctive therapy. This 505(b)(2) application relies on the safety and effectiveness of the discontinued Kapvay (clonidine ER tablets). Pharmacokinetic bridging studies confirm comparable Cmax and AUC between Onyda XR and Kapvay, despite a 26% lower Ctrough,ss for Onyda XR, deemed clinically insignificant for treatment-naïve patients. Onyda XR can be taken with or without food. Safety studies showed no deaths or serious adverse events, with hypotension and bradycardia being the most common, consistent with clonidine's known profile. Bioequivalence was confirmed between Onyda XR and Kapvay under fasting conditions, and between fed and fasted states for Onyda XR.
Key findings — cited to the page
| C24 hr, ss of oral suspension vs LD | 26 % lower | Onyda XR · p.74 |
| Application Type | NDA | Onyda XR · p.2 |
| Application Number | 217645 | Onyda XR · p.2 |
| PDUFA Goal Date | 5/24/24 | Onyda XR · p.2 |
| Review Completion Date | 5/24/24 | Onyda XR · p.2 |
| Proposed Indication | For the treatment of attention-deficit/hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications | Onyda XR · p.2 |
| Recommended Regulatory Action | Approval | Onyda XR · p.2 |
| Recommended Indication | Treatment of attention-deficit/hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to central nervous system (CNS) stimulant medications in pediatric patients 6 years of age and older | Onyda XR · p.2 |
| Starting dosage | 0.1 mg once daily at bedtime | Onyda XR · p.2 |
| Maximum recommended dosage | 0.4 mg once daily at bedtime | Onyda XR · p.2 |
| Clonidine ER OS concentration | 0.1 mg/mL | Onyda XR · p.9 |
| Overall Weight (SD) | 11.6 lbs | · p.72 |
Source: Tris Pharma ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Psychiatry library →