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FDA approves Mydayis for ADHD in adolescents
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The FDA recently approved Mydayis, a once-daily mixed salts of a single-entity amphetamine product from Shire, for treatment of ADHD in individuals aged 13 years and older.
"The approval of Mydayis provides clinicians with another option to treat their patients with ADHD ages 13 and older," study researcher Andrew J. Cutler, MD, executive vice president and chief medical officer at Meridien, told Healio/Psychiatry. "In particular, there is a need for more approved medications for adults with ADHD. Adults have long days, which require control of symptoms in several settings, such as home, school or work, and socially. In clinical trials in adults with ADHD, Mydayis was shown to treat symptoms of ADHD for up to 16 hours. Mydayis therefore provides clinicians with a new once a day treatment that can be effective for their appropriate patients with ADHD ages 13 and older."
The FDA approval is based on findings from 16 clinical studies of Mydayis among more than 1,600 adolescents, aged 13 to 17 years, and adults.
Phase 2 findings indicated improved attention in adults and adolescents who received Mydayis, which reached statistical significance beginning at 2 and 4 hours postdose and continued up to 16 hours postdose.
Phase 3 findings showed change in ADHD-RS-IV total scores from baseline was greater among adolescents and adults who received a morning dose of Mydayis, compared with placebo.
The most common treatment-associated adverse events were insomnia, decreased appetite, decreased weight, dry mouth, increased heart rate and anxiety among adults. Among pediatric participants aged 13 years and older, the most common treatment-associated adverse events included insomnia, decreased appetite, decreased weight, irritability and nausea.
Severity of adverse events was generally mild to moderate across all studies, according to the release.
“Mydayis is the latest innovation in Shire’s 20-year legacy of helping to support the treatment of ADHD. It's a testament to Shire’s commitment to helping support the evolving needs of appropriate patients with ADHD,” Flemming Ornskov, MD, MPH, CEO of Shire, said in the release. “With this approval, we hope to help patients who need a once-daily treatment option. Mydayis has shown efficacy lasting up to 16 hours after taking one capsule, beginning at 2 or 4 hours postdose.”