To Be or Not To Be that is the Question?
When your patients with ADHD need a full day of symptom control.
What is your first choice long acting methylphenidate?
Without ADHD symptom control upon awakening, early morning can be very challenging for children and caregivers..
What is >75% and 47%?
Jornay PM significantly improved behaviors in a laboratory classroom setting vs placebo.
What is Skamp CS from 8:00 AM to 8:00PM at visit 9?
Based on multiple-dose simulations from a PK analysis, negligible accumulation of JPM is predicted.
What is simulater multiple-dose PK profiles of 20 mg and 100 mg of DR/Er MPH?
Participants on JPM showed a statistically significant improvement at each hourly interval.
What would ADHD symptom improvement from 9 AM to 7 PM mean to your patients?
All day adult ADHD symptom control that lasts into the evening continues to be an unmet need.
What is 47% and 56% of adults with ADHD challenges in the evenings and states ideal medication lasting all day?
No short-acting booster was permitted in the pivotal trail.
What would not needing a short-acting booster mean to your patients?
Jornay PM is designed to eliminate multiple peaks & troughs from early morning to evening.
What is the modeled MPH curves with and without SA MPH supplementation compared to JPM?
Secondary Endpoint:Premb-R Am Early morning functional impairment score.
What is Premb-R AM 1.8 improvement vs placebo.
Secondary Endpoint: late afternoon/evening functional impairment.
What is Premb-PM 3.2 improvement vs placebo.
PK/PD data modeled for dose-dependent duration of effect of JPM.
At higher doses, what is predicted to last longer into the evening?
With higher doses, Jornay PM is predicted to last longer into the evening.
What is the Gomeni Study?
Participants on Jornay PM showed a statistically significant improvement at each hourly interval.
What would ADHD symptom improvement from 9 AM to 7PM mean to your patients?
Primary Endpoint: Classroom day. (8AM to 8PM).
What is Skamp combined Score - improvement vs placebo? 5.9
PREM-R AM & PREMB-R PM assesses difficulty of of early morning and late-afternoon and evening functioning.
What is the secondary endpoints? (Clnician-rated assessment based on parent interviews?
Jornay PM is designed to eliminate multiple peaks and troughs from early morning to evening.
What is the unique DR/ER layers of JPM that allow for colonic absorption and smooth onset and offset of effect?
Achieved early morning functioning scores comparable to individuals without ADHD.
What is BSFQ….94%?
At baseline, most patients experienced moderate—to-severe impairment in the late afternoon!
What is Premb-R PM Baseline? (69%)
Model-adjusted average of all postdose Skamp CS measured over a 12 hour laboratory class room day at visit 9
What is the Primary Endpoint?.
No head-to-head clinical PK or efficacy studies have been conducted and therefore data should be interpreted with caution.
What are modeled MPH curves of OROS MPH and JPM?