Ironshore Pharmaceuticals — Jornay Pm FDA Review (NDA209311, ORIG 1, 2018)

Ironshore Pharmaceuticals · 2018 · FDA Review (openFDA)

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Ironshore Pharmaceuticals' Jornay PM (methylphenidate extended-release capsule) for ADHD, NDA 209311, received a positive FDA review after resubmission. Initial concerns regarding high insomnia rates, particularly at higher doses and in younger children, led to a Complete Response. However, subsequent re-evaluation of trial designs and labeling recommendations addressed these safety concerns. Efficacy studies (HLD200-107 and HLD200-108) demonstrated statistically significant improvements in ADHD symptoms (SKAMP CS and ADHD-RS-IV total score) compared to placebo, with effectiveness observed from 9 AM to 4 PM. The reviewer now recommends approval, citing sufficient evidence of effectiveness and safety, with the insomnia issue resolved. Further studies to identify the safest and lowest effective dose were initially recommended but are now considered addressed.

Key findings — cited to the page

Irritability incidence	5.0 %	HLD200-107 · p.41
Irritability incidence	5.0 %	HLD200-107 · p.42
Irritability incidence	5.0 %	HLD200-107 · p.45
Dispute resolution meeting minutes date	May 21, 2018	· p.5
Complete Response action date	July 28, 2017	Jornay PM · p.5
Formal dispute resolution request date	March 27, 2018	· p.5
NDA resubmission date	June 8, 2018	Jornay PM · p.5
PDUFA Goal Date	August 8, 2018	Jornay PM · p.2
Indication	Treatment of ADHD	Jornay PM · p.2
Intended Population	Pediatric patients ages 6 and above	Jornay PM · p.2
Decreased Appetite in 10-12 yrs (Study 108 placebo)	0 %	HLD200-108 · p.21
Application Type	Class 1 NDA resubmission	Jornay PM · p.2

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 →