Shire announced that MYDAYIS (mixed salts of a single-entity amphetamine product), a once-daily, extended-release treatment comprised of three types of drug-releasing beads, is now available by prescription in the United States. The U.S. Food and Drug Administration (FDA) approved Mydayis on June 20, 2017 for patients 13 years and older with Attention Deficit Hyperactivity Disorder (ADHD). Mydayis is not for use in children 12 years and 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,” said Dr. Matthew Brams, Assistant Professor of Clinical Psychiatry at Baylor College of Medicine. “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, other amphetamine containing medicines, and methylphenidate have a high chance for abuse and can cause physical and psychological dependence. Your healthcare provider should check you or your child for signs of abuse and dependence before and during treatment with Mydayis. Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs. Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
The U.S. FDA approval of Mydayis was based on results from 16 clinical studies evaluating Mydayis in more than 1,600 subjects, including adolescents (aged 13 to 17 years) and adults with ADHD. In pivotal, placebo-controlled clinical studies, Mydayis significantly improved symptoms of ADHD, as measured by the ADHD-RS-IV and the Permanent Product Measure of Performance (PERMP), in adults and adolescents. Improvement on the PERMP, an objective, validated, skill-adjusted math test that measures attention in ADHD patients, reached statistical significance at up to 16 hours post-dose, beginning at 2 to 4 hours post-dose. People living with ADHD should work with a healthcare professional to determine whether a pharmacological treatment is appropriate for them, and if so, which one meets their individual needs.
In pivotal Phase 3 clinical studies where efficacy was the primary endpoint, a morning dose of Mydayis demonstrated superiority to placebo based on the change from baseline in the ADHD-RS-IV total score for adult and adolescent patients, respectively. The most common adverse reactions associated with Mydayis (incidence greater than or equal to 5% and at a rate at least twice placebo) in adults were insomnia, decreased appetite, decreased weight, dry mouth, increased heart rate, and anxiety. For pediatric patients (13 years and older), the most 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,” said Perry Sternberg, Head, U.S. Commercial. “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.”
In Phase 2 studies (two studies in adults and one in adolescents), patients treated with Mydayis demonstrated improved attention compared to placebo, as assessed by the total PERMP score, with results reaching statistical significance beginning at 2 or 4 hours post-dose and lasting up to 16 hourspost-dose. Across all clinical studies, adverse events were generally mild to moderate in severity and similar to those observed with other amphetamine compounds.
An estimated 4.4% of adults have ADHD in the U.S. When applied to the full U.S. adult population aged 18 and over, approximately 10.5 million adults are estimated to have ADHD. Approximately 50 to 66% of children with ADHD may continue to have ADHD symptoms as adults. Medication is not appropriate for all individuals diagnosed with ADHD.
With the availability of Mydayis, Shire has patient-focused resources to share information about prescription coverage and savings, including a co-pay savings offer. This savings offer will be available for eligible commercially insured patients to help save on their Mydayis prescriptions.
Filed Under: Drug Discovery