Xelstrym

Psychiatry· 609 cited findings· 1 source document

Company: NOVEN PHARMS INC

What the regulatory reviews say

Xelstrym (d-ATS) is a transdermal system developed by Noven Pharmaceuticals, Inc. for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older. The application for Xelstrym, NDA215401, received a recommendation for approval from the FDA's Psychiatry Division.

Efficacy findings indicate that Xelstrym demonstrated a duration of primary efficacy of 12 hours, with an onset of efficacy at 2 hours. In comparison to Vyvanse, the Cmax LS GeoMean Ratio for d-ATS was 66.6%, and the AUC0-inf LS GeoMean Ratio was 78.6%. When compared to Adderall XR, the Cmax LS GeoMean Ratio for d-ATS was 94.9%, and the AUC0-inf LS GeoMean Ratio was 109.2%. The mean total SKAMP score difference for d-ATS versus placebo was -4.7 in Period 1 (Week 6) and -7.1 in Period 2 (Week 7).

Safety evaluations included a NOAEL for kidney findings at 2 mg/kg/day and for histopathology findings and dermal scores at 0.4 mg/kg. The embryo-fetal development NOAEL was 20 mg/kg. A decrease in body weight of 11-15% versus controls was observed.

Key figures — cited to the source page

Cmax LS GeoMean Ratio d-ATS/Vyvanse	66.6 %	NOVEN PHARMS INC — Xelstrym FDA Review (NDA215401, ORIG 1, 2, p.178
Cmax LS GeoMean Ratio d-ATS/Adderall XR	94.9 %	NOVEN PHARMS INC — Xelstrym FDA Review (NDA215401, ORIG 1, 2, p.178
AUC0-inf LS GeoMean Ratio d-ATS/Vyvanse	78.6 %	NOVEN PHARMS INC — Xelstrym FDA Review (NDA215401, ORIG 1, 2, p.178
AUC0-inf LS GeoMean Ratio d-ATS/Adderall XR	109.2 %	NOVEN PHARMS INC — Xelstrym FDA Review (NDA215401, ORIG 1, 2, p.178
Onset of efficacy	2 hours	NOVEN PHARMS INC — Xelstrym FDA Review (NDA215401, ORIG 1, 2, p.16
Duration of primary efficacy	12 hours	NOVEN PHARMS INC — Xelstrym FDA Review (NDA215401, ORIG 1, 2, p.16
NOAEL for kidney findings	2 mg/kg/day	NOVEN PHARMS INC — Xelstrym FDA Review (NDA215401, ORIG 1, 2, p.39
Recommendation on Regulatory Action	Approval	NOVEN PHARMS INC — Xelstrym FDA Review (NDA215401, ORIG 1, 2, p.2

Source documents

NOVEN PHARMS INC — Xelstrym FDA Review (NDA215401, ORIG 1, 2022) (2022)

Explore the full evidence

All 609 cited findings for Xelstrym — 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.