The US Food and Drug Administration (FDA) has approved a long-acting medication for attention-deficit/hyperactivity disorder (ADHD) from Shire called Mydayis (mixed salts of a single-entity amphetamine product).
The once-daily treatment comprises three different types of drug-releasing beads and is formulated to last up to 16 hours. It is approved for adults and children aged 13 years and older with ADHD. Mydayis is is not for use in children aged 12 years and younger.
The approval of Mydayis was based on results from 16 clinical studies that evaluated the stimulant in more than 1600 patients, including adolescents (aged 13 to 17 years) and adults with ADHD.
In both adults and adolescents, Mydayis significantly improved symptoms of ADHD, as measured by the ADHD Rating Scale IV and the Permanent Product Measure of Performance (PERMP), Shire said in a news release.
"Improvement on the PERMP, an objective, validated, skill-adjusted math test that measures attention in ADHD patients, reached statistical significance beginning at 2 or 4 hours post-dose and lasting up to 16 hours post-dose," they note.
In children aged 13 years and older, the most common side effects are insomnia, decreased appetite, decreased weight, irritability, and nausea.
In adults, the most common side effects (incidence ≥5% and at a rate at least twice placebo) are insomnia, decreased appetite, decreased weight, dry mouth, increased heart rate, and anxiety.
"Across all clinical studies, adverse events were generally mild to moderate in severity and similar to those observed with other amphetamine compounds," the company said.
"Many of my patients living with ADHD are trying to manage symptoms that impact them in different settings – often across home life, school, or work, and in social settings," Andrew J. Cutler, MD, of Meridien Research, who was an investigator in the Mydayis clinical trials, said in the release. "Patients have individual needs and may respond differently to treatments, so it is important for healthcare professionals to have multiple options."
Shire said it expects that Mydayis will be commercially available in the United States in the third quarter of this year.
Cite this: FDA Clears Long-Acting ADHD Drug Mydayis - Medscape - Jun 21, 2017.