Layout table for study information
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Study of the Duration and Efficacy of MY|
|Actual Study Start Date :||July 15, 2020|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Feb 20 2021
What is Mydayis ER?
Indications and Usage for Mydayis ER Capsules. MYDAYIS is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older [see Clinical Studies (14)].
Is Mydayis an amphetamine?
end early. MYDAYIS ® is the first and only mixed amphetamine salts (MAS) formulation that may help with improved attention up to 16 hours post-dose (measured from 2 or 4 hours) with once-daily dosing.1 Primary Endpoint1: Significant improvements in attention based on LS mean PERMP total scores up to 16 h post-dose.
Can Mydayis cause insomnia?
Patients ≤12 years experienced higher plasma exposure at the same dose and higher rates of adverse reactions, mainly insomnia and decreased appetite. CNS stimulants, including Mydayis, other amphetamine-containing products, and methylphenidate, have a high potential for abuse and dependence.
How to administer Mydayis?
MYDAYIS may be administered in one of the following ways: Open capsule and sprinkle the entire contents over a spoonful of applesauce. The sprinkled applesauce should be consumed immediately; it should not be stored. Patients should take the sprinkled applesauce in its entirety without chewing. The dose of a single capsule should not be divided.
What is Mydayis used for?
MYDAYIS is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older [see Clinical Studies (14)].
What is Mydayis ER capsules?
Mydayis ER Capsules Description. MYDAYIS extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. MYDAYIS contains equal amounts (by weight) of four salts: dextroamphetamine sulfate and amphetamine sulfate, dextroamphetamine saccharate and amphetamine aspartate monohydrate.
What is Mydayis prescription medication?
Mydayis is a brand-name prescription medication. It’s used to treat attention deficit hyperactivity disorder (ADHD) in adults as well as children ages 13 years and older. ADHD is a mental health condition that can cause problems such as having trouble paying attention or sitting still. Mydayis belongs to a class of medications called stimulants.
What are the ingredients in Mydayis?
MYDAYIS contains equal amounts (by weight) of four salts: dextroamphetaminesulfate and amphetamine sulfate, dextroamphetamine saccharate and amphetamine aspartate monohydrate. This results in a 3:1 mixture of dextro-to levoamphetamine base equivalent. The 12.5 mg, 25 mg, 37.5 mg and 50 mg strength capsules are for oral administration.