FDA Approves Once-Daily ADHD Treatment Mydayis for Patients 13 Years and Older
A new long-acting medication, known as Mydayis, will be available to treat ADHD exclusively in teens and adults beginning in late 2017.
Reviewed on March 23, 2018
June 21, 2017
Yesterday, the FDA approved Mydayis, a new medication for attention deficit disorder (ADHD or ADD) designed for all-day symptom control in patients 13 years of age or older. Shire, Mydayis’ manufacturer, stated in a press release that the medication would become available to consumers in the third quarter of 2017.
Mydayis is a long-acting, triple-bead, mixed amphetamine salts formulation planned for once-daily ADHD treatment for adults and children patients 13 and older.
Mydayis’ efficacy was tested on more than 1,600 subjects, all over the age of 13, over the course of 16 clinical studies. Mydayis was found to significantly improve ADHD symptoms in subjects when compared to a placebo, researchers reported — starting at 2 to 4 hours post-dose and lasting up to 16 hours.
Shire reports that side effects across all studies were generally “mild to moderate in severity,” and similar to those associated with other amphetamines. The most common side effects in adults were decreased appetite, weight loss, sleeplessness, dry mouth, increased heart rate, and anxiety. Teens between the ages of 13 and 17 most commonly reported sleeplessness, nausea, irritability, and weight and appetite loss.
Shire first applied for FDA approval for Mydayis in 2006, but were instructed to conduct additional studies. Following yesterday’s approval, Shire announced plans to launch Mydayis later in 2017.
“With this approval, we hope to help patients who need a once-daily treatment option,” said Flemming Ornskov, M.D., MPH, CEO of Shire.