Azstarys
Psychiatry· 748 cited findings· 1 source document
Company: COMMAVE SUB
What the regulatory reviews say
Azstarys (NDA 212994) is approved for the treatment of ADHD in patients aged 6 years and older. The recommended regulatory action was approval for the treatment of ADHD in patients aged 6 to 12 years. The recommended dosing regimen is 26.1/5.2 mg once daily in the morning, with weekly increases in increments of 13.1/2.6 mg per day up to a maximum of 52.3/10.4 mg.
Efficacy was demonstrated with an onset of action at 1 hour post-dose and a duration of action of 9 hours. In a protocol-specified analysis, the SKAMP-C score change from baseline for Azstarys (KP415) was -4.87, compared to 0.54 for placebo, resulting in a treatment difference of -5.4 (p-value <0.001). The SKAMP combined score change from baseline (LS mean difference) was -5.4. Study KP415.E01 enrolled 150 patients.
Regarding safety, 11 patients dropped out due to adverse events in study KP415.S01 and 4 in study KP415.E01. The d-MPH Cmax for KP415 (52.3/10.4 mg) was 14.0 ng/mL, while for Focalin XR (40 mg) it was 28.2 ng/mL. The d-MPH AUC for KP415 (52.3/10.4 mg) was 186 hour*ng/mL, compared to 248 hour*ng/mL for Focalin XR (40 mg).
Key figures — cited to the source page
| SKAMP combined score change from baseline (LS mean difference) | -5.4 | COMMAVE SUB — Azstarys FDA Review, p.5 |
| Onset of action | 1 | COMMAVE SUB — Azstarys FDA Review, p.5 |
| Duration of action | 9 | COMMAVE SUB — Azstarys FDA Review, p.5 |
| SKAMP-C score treatment difference (protocol-specified analysis) | -5.4 | COMMAVE SUB — Azstarys FDA Review, p.12 |
| Dropouts due to AEs (KP415.S01) | 11 | COMMAVE SUB — Azstarys FDA Review, p.15 |
| Approved Indication | Treatment of ADHD in patients ages 6 years and older | COMMAVE SUB — Azstarys FDA Review, p.2 |
| Recommended Regulatory Action | Approval | COMMAVE SUB — Azstarys FDA Review, p.20 |
| Study KP415.E01 enrollment | 150 | COMMAVE SUB — Azstarys FDA Review, p.3 |
Source documents
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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.