COMMAVE SUB — Azstarys FDA Review (NDA212994, ORIG 1, 2021)

COMMAVE SUB · 2021 · FDA Review (openFDA)

Report summary

The FDA approved Azstarys (serdexmethylphenidate and dexmethylphenidate) for ADHD in patients aged 6 and older. Efficacy was established in children (6-12 years) via Study KP415.E01, showing significant improvement in ADHD symptoms with rapid onset and sustained duration. Efficacy in adolescents and adults was extrapolated from Focalin XR. Nonclinical safety studies confirmed a toxicological profile comparable to d-MPH, with no unique toxicities. Pharmacokinetic data showed no significant drug interactions. Abuse potential studies indicated Azstarys had lower abuse potential than active comparators (Focalin XR, d-Methylphenidate) across various administration routes, though it varied compared to placebo. Common stimulant-related adverse events were noted, along with a suppressive effect on pediatric growth. Azstarys was classified as Schedule II. Postmarketing requirements include further pediatric studies.

Key findings — cited to the page

d-MPH Cmax (Focalin XR 40 mg)	28.2 ng/mL	Focalin XR · p.7
d-MPH AUC (KP415 52.3/10.4 mg)	186 hour*ng/mL	KP415 · p.7
Study KP415.E01 enrollment	150 patients	KP415.E01 · p.3
d-MPH Cmax (KP415 52.3/10.4 mg)	14.0 ng/mL	KP415 · p.7
Duration of action	9 hours	KP415 · p.5
Onset of action	1 hour post-dose	KP415 · p.5
NDA/BLA Number	212994	Azstarys (KP415) · p.2
Dropouts due to AEs (KP415.S01)	11	KP415.S01 · p.15
Approved Indication	Treatment of ADHD in patients ages 6 years and older	Azstarys (KP415) · p.2
PDUFA Goal Date	03/02/2021	· p.2
SKAMP combined score change from baseline (LS mean difference)	-5.4	KP415.E01 · p.5
d-MPH AUC (Focalin XR 40 mg)	248 hour*ng/mL	Focalin XR · p.7

Source: COMMAVE SUB ↗ · 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 →