Jornay Pm
Psychiatry· 377 cited findings· 2 source documents
Company: Ironshore Pharmaceuticals
What the regulatory reviews say
Jornay Pm is a medication indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in pediatric patients aged 6 years and above. The application for Jornay Pm was a Class 1 NDA resubmission, with the original NDA submitted on September 30, 2016, and a complete response action date of July 28, 2017. The PDUFA Goal Date was August 8, 2018, and the review was completed on August 7, 2018.
Efficacy findings from studies comparing HLD200 to placebo include a SKAMP score mean difference of -5.9 and a statistically significant SKAMP CS difference (p = 0.010), with an onset of primary efficacy (SKAMP CS) at 9:00 am. Additional efficacy measures showed BSFQ LS Mean Differences (HLD200-Placebo) ranging from -4.5 to -11.4, PREMB-R AM LS Mean Differences (HLD200-Placebo) from -1.0 to -1.7, and PREMB-R PM LS Mean Differences (HLD200-Placebo) from -2.3 to -4.4.
Notable safety findings include initial insomnia rates of 6% (Study 107) and 14% (Study 108). In Study 108, insomnia rates for HLD200 were 43% in 6-9 year olds and 30.4% in 10-12 year olds, compared to placebo rates of 16.7% and 9.4% respectively. Decreased appetite was observed in 20% of 6-9 year olds receiving HLD200 in Study 108.
Key figures — cited to the source page
| SKAMP score mean difference (HLD200 vs placebo) | -5.9 | Ironshore Pharmaceuticals — Jornay Pm FDA Review (NDA209311,, p.7 |
| SKAMP CS difference (HLD200 vs placebo) | statistically significant | Ironshore Pharmaceuticals — Jornay Pm FDA Review (NDA209311,, p.22 |
| SKAMP CS difference (HLD200 vs placebo) | p = 0.010 | Ironshore Pharmaceuticals — Jornay Pm FDA Review (NDA209311,, p.22 |
| Onset of primary efficacy (SKAMP CS) | 9:00 am | Ironshore Pharmaceuticals — Jornay Pm FDA Review (NDA209311,, p.22 |
| Insomnia rate in 6-9 yrs (Study 108 HLD200) | 43 | Ironshore Pharmaceuticals — Jornay Pm FDA Review (NDA209311,, p.21 |
| Insomnia rate in 10-12 yrs (Study 108 HLD200) | 30.4 | Ironshore Pharmaceuticals — Jornay Pm FDA Review (NDA209311,, p.21 |
| Decreased Appetite in 6-9 yrs (Study 108 HLD200) | 20 | Ironshore Pharmaceuticals — Jornay Pm FDA Review (NDA209311,, p.21 |
| Indication | Treatment of ADHD | Ironshore Pharmaceuticals — Jornay Pm FDA Review (NDA209311,, p.2 |
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.