NOVEN PHARMS INC — Xelstrym FDA Review (NDA215401, ORIG 1, 2022)
NOVEN PHARMS INC · 2022 · FDA Review (openFDA)
Report summary
Noven Pharmaceuticals' Xelstrym (dextroamphetamine transdermal system; d-ATS) is approved for ADHD in patients aged 6 and older, with dosages from 4.5 mg/9 hours to 18 mg/9 hours. Efficacy, supported by a Phase 2 study and bridging data to Vyvanse, shows onset at 2 hours and duration up to 9-12 hours. Safety relies on Adderall XR and Vyvanse data, with specific dermal safety studies. Common adverse events include decreased appetite, insomnia, and application site reactions. Non-clinical toxicology showed skin-related findings but no genetic or reproductive toxicity. Clinical pharmacology highlighted dosing recommendations, the importance of site rotation, and cautioned against external heat. Pharmacokinetic studies confirmed acceptable adhesion and compared d-ATS exposure to other ADHD medications. A PREA waiver for ages 0-5 was granted due to safety concerns.
Key findings — cited to the page
| NOAEL for local irritation and body weight gain decreases | 0.5 mg/day | A 90-day Study of Amphetamine Transdermal System (ATS) Degradants by Dermal Administration in Rats with a 28-day Recovery Period · p.41 |
| Irritation incidence (d-ATS) | 38 % | Study N25-006 · p.129 |
| Irritability incidence | 2 % | Study N25-006 · p.125 |
| Irritability incidence (Vyvanse) | 10 % | · p.126 |
| Irritation incidence (d-ATS) | 46 % | Study N25-006 · p.129 |
| Irritation incidence (d-ATS) | 45 % | Study N25-006 · p.129 |
| Irritation incidence (d-ATS) | 58 % | Study N25-006 · p.129 |
| Irritability incidence | 17 % | Study N25-006 · p.124 |
| Irritability incidence (placebo) | 1 % | Study N25-006 · p.125 |
| Irritability incidence (d-ATS) | 17 % | Study N25-006 · p.126 |
| Irritation incidence (d-ATS) | 49 % | Study N25-006 · p.129 |
| Irritation incidence (d-ATS) | 46 % | Study N25-006 · p.129 |
Source: NOVEN PHARMS 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 →