Shire and Shionogi’s Intuniv, a once-daily non-stimulant for adults with attention-deficit/hyperactivity disorder (ADHD), met its primary endpoint and showed a superior change from baseline compared with placebo in a phase 3 study.
The study included adults in Japan age 18 years and older who had ADHD. The drug is already approved as a treatment for patients between the ages of 6 and 17 years in Japan, the United States, and other countries, and is now being evaluated in Japan to treat ADHD in adults. Japan is the third-largest market for ADHD.
This 12-week, randomized, double-blind, multi-center, placebo-controlled study was the first clinical trial evaluating Intuniv in adults. A total of 201 adult patients with ADHD participated in the study. The study showed that Intuniv was superior to placebo based on a clinically administered ADHD rating scale total score. The treatment was also superior to placebo in improving patients’ global functioning.
“The positive topline results of this phase 3 study provide us with important data and insights regarding the clinical profile of Intuniv in adult patients with ADHD,” Brigitte Robertson, MD, vice president and head of Global Clinical Development, Neuropsychiatry, Shire, said in a statement
. “We are evaluating the full data set, and excited to advance the development of INTUNIV as a non-stimulant treatment option for adults with ADHD in Japan, building on the established efficacy and safety data for ADHD in child and adolescent patients.”
Adverse events in the study were mild to moderate, and the researchers reported no new or unexpected safety findings compared with previous Intuniv studies. The most common adverse events were somnolence, dry mouth, blood pressure decrease, nospharyngitis, dizziness postural, and constipation.