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ADHD

Psychiatryยท 9 reviewed drugsยท 4558 cited findings behind them

What the regulatory reviews cover

Regulatory review documents in this library cover several drugs for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). These include Qelbree (viloxazine ER), indicated for pediatric patients 6 to 17 years of age, which showed an ADHD-RS-5 Total Score LS Mean Difference from Placebo (SPN-812 ER 200 mg/day) of -7.8. Azstarys, indicated for patients ages 6 years and older, demonstrated a SKAMP combined score change from baseline (LS mean difference) of -5.4. COTEMPLA XR-ODT, for children aged 6-12 years, reported SKAMP-Combined scores LS mean difference vs placebo of -11.0. Jornay Pm, for ADHD treatment, showed a SKAMP score mean difference (HLD200 vs placebo) of -5.9. It is important to note that these figures are derived from different trials and are not directly comparable head-to-head.

The drugs โ€” one cited result each

Qelbree / viloxazine ER

Supernus Pharmaceuticals, Inc.

ADHD-RS-5 Total Score LS Mean Difference from Placebo (SPN-812 ER 200 mg/day): -7.8

Supernus Pharmaceuticals, Inc. โ€” Qelbree FDA Review (NDA2119, p.239

Azstarys

COMMAVE SUB

SKAMP combined score change from baseline (LS mean difference): -5.4

COMMAVE SUB โ€” Azstarys FDA Review, p.5

Xelstrym

NOVEN PHARMS INC

Cmax LS GeoMean Ratio d-ATS/Vyvanse: 66.6 %

NOVEN PHARMS INC โ€” Xelstrym FDA Review (NDA215401, ORIG 1, 2, p.178

Slenyto

RAD Neurim Pharmaceuticals

580 cited findings on the drug page โ†’
Jornay Pm

Ironshore Pharmaceuticals

SKAMP score mean difference (HLD200 vs placebo): -5.9

Ironshore Pharmaceuticals โ€” Jornay Pm FDA Review (NDA209311,, p.7

COTEMPLA XR-ODT

NEOS THERAPS INC

SKAMP-Combined scores LS mean difference vs placebo: -11.0

NEOS THERAPS INC โ€” Cotempla Xr-Odt FDA Review (NDA205489, OR, p.26

Dyanavel XR

Tris Pharma

Duration of clinical efficacy for Amphetamine ER tablets: one hour to 13 hours

Tris Pharma โ€” Dyanavel Xr FDA Review (NDA210526, ORIG 1, 202, p.32

Tuzulby

Neuraxpharm

SKAMP-Combined score (LS mean) change from placebo: -7.0

Neuraxpharm โ€” Tuzulby EMA EPAR variation assessment report, p.61

Onyda XR

Tris Pharma

Deaths: 0

Tris Pharma โ€” Onyda Xr FDA Review, p.44

Different drugs were studied in different trials โ€” these figures are not head-to-head comparisons.

Explore the full evidence

Every finding behind these drugs โ€” searchable, comparable and answerable in plain language โ€” is in the Psychiatry research library โ†’

Lists reflect the regulatory review documents in this library, not all therapies that exist. Educational reference only โ€” not medical or investment advice.

ADHD โ€” 9 Drugs, FDA & EMA Review Findings | BioPharmaPT Psychiatry