The mixed amphetaminies salts formulation included 16 clinical trials results in its application.
The US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) of mixed salts of a single-entity amphetamine product (MYDAYIS) for attention-deficit/hyperactivity disorder (ADHD).
Mydayis, a long-acting, triple-bead, mixed amphetamine salts formulation, is a planned once-daily ADHD treatment for adult and children patients ages 13 years and older.
The submitted NDA for the treatment featured 16 clinical studies, including SHP465-305 — a short-term efficacy and safety study in pediatric ADHD patients aged 6-17 that returned positive results in June 2016.
Adolescent and adult clinical studies of Mydayis also reported statistically significant differences versus placebo at 16 hour post-dosing periods, with onset of action starting 2 or 4 hours post-dosing, as measured by the Permanent Product Measure of Performance (PERMP) scale.
The mixed salts formulation treatment is Irish-headquartered biopharmaceutical company Shire's most recent innovation in 2 decades of ADHD treatment support, Flemming Ornskov, MD, MPH, chief executive officer of Shire, said.
"It’s a testament to Shire’s commitment to helping support the evolving needs of appropriate patients with ADHD,” Flemming said. “With this approval, we hope to help patients who need a once-daily treatment option."
Adverse effects reported in Mydayis phase III studies included insomnia, decreased appetite, dry mouth, decreased weight, increased heart rate, and more, in all patient age groups.
Andrew J. Cutler, MD, is executive vice president and chief medical officer at Meridien Research and an investigator in the Mydayis clinical trials. He noted many patients living with ADHD are managing symptoms across a wide range of settings.
"Patients have individual needs and may respond differently to treatments, so it is important for healthcare professionals to have multiple options," Cutler said. "It’s rewarding to work with Shire to provide a new treatment option that may help appropriate patients with ADHD.”
Shire noted in a press release regarding the approval that Mydayis, as an amphetamine-containing medicine, has a high chance for abuse in patients and can lead to physical and psychological dependence.