FDA Approves Shire’s New ADHD Drug

No stranger to the ADHD market, Shire has announced that their new drug Mydayis (mixed salts of a single-entity amphetamine product) has been approved by the FDA. The drug has been approved to treat ADHD in adolescents and adults over the age of 13.

“Mydayis is the latest innovation in Shire’s 20-year legacy of helping to support the treatment of ADHD,” said Dr. Flemming Ornskov, CEO of Shire. “It’s a testament to Shire’s commitment to helping support the evolving needs of appropriate patients with ADHD.”

According to Shire, Mydayis contains three different forms of drug-releasing beads that contribute to the ADHD medication’s once-daily dosing schedule. Shire’s bestselling Adderall XR contains the same active ingredient as Mydayis, however it is not as long-acting.

“With this approval, we hope to help patients who need a once-daily treatment option,” said Ornskov. “Mydayis has shown efficacy lasting up to 16 hours after taking one capsule, beginning at two or four hours post-dose.”

In all, 16 clinical studies were conducted to evaluate the safety and efficacy of Mydayis in patients with ADHD. Based in the ADHD-RS-IV and the Permanent Product Measure of Performance (PERMP) scales, patients treated with Mydayis showed significantly improved symptoms of ADHD, compared to the placebo.

In addition, patients given Mydayis reached statistical significance on the PERMP in just two to four hours post-dose. Improved scores on the math-based measure of attention also persisted up to 16 hours after dosing.

“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,” said Dr. Andrew J. Cutler, Executive Vice President and Chief Medical Officer at Meridien Research and an investigator in the Mydayis clinical trials. “Patients have individual needs and may respond differently to treatments, so it is important for healthcare professionals to have multiple options. It’s rewarding to work with Shire to provide a new treatment option that may help appropriate patients with ADHD.”

About 4.4 percent of adults in the US are believed to have ADHD, a condition that manifests as inattention and hyperactivity that can interfere with daily tasks. Shire’s launch of Mydayis is expected to come in the third quarter of 2017.