Vanda Pharmaceuticals Inc. — Hetlioz FDA Review (NDA214517, ORIG 1, 2020)
Vanda Pharmaceuticals Inc. · 2020 · FDA Review (openFDA) · company profile →
Report summary
The FDA reviewed Vanda Pharmaceuticals' Hetlioz (tasimelteon capsules and oral suspension) for treating nighttime sleep disturbances in Smith-Magenis Syndrome (SMS). This resubmission, granted Priority Review, included a pivotal crossover study (Study 2401) demonstrating statistically significant improvement in caregiver-reported nighttime sleep quality with tasimelteon. The drug exhibited a benign safety profile, with no clear pattern of serious adverse events, though causality was complicated by patient comorbidities. While actigraphy data could not support regulatory decisions, efficacy was consistent across subgroups. The review also covered pediatric dosing, non-clinical safety, and postmarketing commitments.
Key findings — cited to the page
| Application number(s) | 214517 and 205677-007 | Hetlioz · p.2 |
| PDUFA goal date | 12/1/2020 | Hetlioz · p.2 |
| Review completion date | 11/30/2020 | Hetlioz · p.2 |
| Established/proper name | Tasimelteon | Hetlioz · p.2 |
| Proposed proprietary name | Hetlioz | Hetlioz · p.2 |
| Pharmacologic class | Melatonin receptor agonist | Hetlioz · p.2 |
| Code name | VEC-162 | Hetlioz · p.2 |
| Applicant | Vanda Pharmaceuticals Inc. | Hetlioz · p.2 |
| Dosage form(s)/formulation(s) | Capsules: 20 mg; Suspension (4 mg/mL) | Hetlioz · p.2 |
| Dosing regimen (pediatric patients 3 to 15 years of age, ≤28 kg) | 0.7 mg/kg suspension by mouth one hour before bedtime | Hetlioz · p.2 |
| Dosing regimen (pediatric patients 3 to 15 years of age, >28 kg) | 20 mg suspension by mouth one hour before bedtime | Hetlioz · p.2 |
| Application type | Resubmission: NDA and Efficacy Supplement | Hetlioz · p.2 |
Source: Vanda Pharmaceuticals Inc. ↗ · 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 →