Onyda XR(clonidine hydrochloride extended-release oral suspension)
Psychiatry· 80 cited findings· 1 source document
Company: Tris Pharma
What the regulatory reviews say
Onyda XR (clonidine hydrochloride extended-release oral suspension) is an investigational drug for which a New Drug Application (NDA 217645) has been submitted by Tris Pharma. The proposed indication is for the treatment of attention-deficit/hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications. The recommended regulatory action is Approval, with a recommended indication for the 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. The PDUFA Goal Date and Review Completion Date are both 5/24/24. The starting dosage is 0.1 mg once daily at bedtime.
In terms of efficacy, the C24 hr, ss of the oral suspension was 26% lower compared to the loading dose. Safety findings indicate no deaths or serious adverse events were reported. One subject discontinued due to an adverse event. The number of subjects reporting adverse events varied across treatments: 15 in Treatment A, 16 in Treatment B, and 13 in Treatment C. The incidence of hypotension was 14 in Treatment A, 14 in Treatment B, and 9 in Treatment C. The incidence of bradycardia was 4 in Treatment A.
Studies involved various numbers of subjects. For instance, Study 2021-5094 enrolled 23 subjects, and Study 2021-5095 enrolled 20 subjects. The number of subjects exposed to clonidine ER OS was 16 in Study 20-VN-034, 22 in Study 2021-5094, and 19 in Study 2021-5095.
Key figures — cited to the source page
| C24 hr, ss of oral suspension vs LD | 26 | Tris Pharma — Onyda Xr FDA Review, p.74 |
| Deaths | 0 | Tris Pharma — Onyda Xr FDA Review, p.44 |
| Serious Adverse Events | 0 | Tris Pharma — Onyda Xr FDA Review, p.44 |
| Subjects discontinued due to AE | 1 | Tris Pharma — Onyda Xr FDA Review, p.72 |
| Incidence of Hypotension (Trt A) | 14 | Tris Pharma — Onyda Xr FDA Review, p.46 |
| Incidence of Hypotension (Trt B) | 14 | Tris Pharma — Onyda Xr FDA Review, p.46 |
| Incidence of Hypotension (Trt C) | 9 | Tris Pharma — Onyda Xr FDA Review, p.46 |
| Recommended Regulatory Action | Approval | Tris Pharma — Onyda Xr FDA Review, p.2 |
Source documents
Explore the full evidence
All 80 cited findings for Onyda XR — searchable, comparable and answerable in plain language — are in the Psychiatry research library →
Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.