A once-daily treatment that lasts up to 16 hours post-dose for patients older than 13 years who have attention-deficit/hyperactivity disorder (ADHD) is now available in the United States. Shire plc launched Mydayis on August 28 after it was approved by the FDA on June 20. Mydayis is not approved for use in children 12 years or younger.
“In my practice, my patients remind me every day that each individual's needs vary; this has made it increasingly important to have different approaches to help my patients manage their ADHD symptoms,” Matthew Brams, MD, assistant professor of Clinical Psychiatry at Baylor College of Medicine, said in a statement
. “The availability of Mydayis is a new addition to the options healthcare professionals have to consider as they help patients who continually struggle with ADHD symptoms.”
Mydayis was approved on 16 clinical studies that evaluated it in more than 1600 patients, including adolescents and adults. The trials found that Mydayis significantly improved symptoms of ADHD starting 2 to 4 hours after the dose was administered and lasting up to 16 hours.
Phase 3 studies found the most common adverse reactions included insomnia, decreased appetite, decreased weight, dry mouth, increased heart rate, and anxiety in adults. In adolescents, common adverse reactions were insomnia, decreased appetite, decreased weight, irritability, and nausea.
“We recognize that patients with ADHD have varied needs when it comes to managing their symptoms,” Perry Sternberg, head of US Commercial at Shire, said. “Mydayis, which has shown efficacy at up to 16 hours post-dose, beginning at 2 to 4 hours post-dose, provides a new once-daily option for appropriate patients.”
Approximately 50% to 66% of children with ADHD continue to have ADHD symptoms as adults. There are an estimated 10.5 million adults in the United States who have ADHD, but less than 20% of them have been diagnosed or treated, according
to the Anxiety and Depression Association of America.
Shire noted in Mydayis’ safety information that the drug, like other amphetamine-containing medicines, has a high chance for abuse and can cause physical and psychological dependence. Patients are recommended to tell healthcare providers if they have ever abused or been dependent on alcohol, prescription medicines, or street drugs.