Ironshore Pharmaceuticals — Jornay Pm FDA Review (NDA209311, ORIG 1, 2018)
Ironshore Pharmaceuticals · 2018 · FDA Review (openFDA)
Report summary
This statistical review evaluates Ironshore Pharmaceuticals' NDA for Jornay PM (Methylphenidate Hydrochloride capsules) for ADHD treatment. It synthesizes findings from two pivotal studies, HLD200-107 and HLD200-108, which demonstrated statistically significant efficacy compared to placebo in children aged 6-12. Primary and secondary endpoints, including SKAMP combined scores, PREMB-R AM, and ADHD-RS-IV total scores, showed significant improvements. The drug's effect duration was observed from 9 AM to 4 PM. While the review confirms the drug's efficacy, it notes some data integrity issues and FDA disagreement on certain secondary endpoints. Subgroup analyses by gender and race were also presented.
Key findings — cited to the page
| BSFQ LS Mean Diff (HLD200-Placebo) | -8.4 | HLD200-108 · p.42 |
| BSFQ LS Mean Diff (HLD200-Placebo) | -11.4 | HLD200-108 · p.42 |
| BSFQ LS Mean Diff (HLD200-Placebo) | -4.5 | HLD200-108 · p.42 |
| PREMB-R AM LS Mean Diff (HLD200-Placebo) | -1.5 | HLD200-108 · p.42 |
| PREMB-R AM LS Mean Diff (HLD200-Placebo) | -1.7 | HLD200-108 · p.42 |
| PREMB-R AM LS Mean Diff (HLD200-Placebo) | -1.3 | HLD200-108 · p.42 |
| PREMB-R AM LS Mean Diff (HLD200-Placebo) | -1.0 | HLD200-108 · p.42 |
| PREMB-R PM LS Mean Diff (HLD200-Placebo) | -2.8 | HLD200-108 · p.42 |
| PREMB-R PM LS Mean Diff (HLD200-Placebo) | -4.4 | HLD200-108 · p.42 |
| PREMB-R PM LS Mean Diff (HLD200-Placebo) | -2.3 | HLD200-108 · p.42 |
| PREMB-R PM LS Mean Diff (HLD200-Placebo) | -3.4 | HLD200-108 · p.42 |
| BSFQ LS Mean Diff (HLD200-Placebo) | -10.3 | HLD200-108 · p.42 |
Source: Ironshore Pharmaceuticals ↗ · 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 →