New Drug Application Submitted in Japan for INTUNIV (guanfacine hydrochloride extended release) in Adults with ADHD

Shire (LSE:SHP, NASDAQ:SHPG) announces that its partner in Japan, Shionogi & Co., Ltd has submitted a New Drug Application (NDA) for the manufacture and marketing in Japan of INTUNIV (guanfacine hydrochloride extended release) for the treatment of attention deficit hyperactivity disorder (ADHD) in adults. The Japanese Phase 3 clinical trial was the first ever to evaluate INTUNIV in adult patients (18 years and over) with ADHD.

As quoted in the press release:

“This is a key milestone, taking us a step closer to potentially providing INTUNIV to adults in Japan in addition to the approved pediatric indication,” said Brigitte Robertson, M.D., VP and Head of Global Clinical Development, Neuroscience, Shire. “There remains a significant need for new non-stimulant treatment options for adults being diagnosed with ADHD in Japan,” she said.

INTUNIV, a non-stimulant, selective alpha-2A adrenergic receptor agonist² has been approved as a treatment for child and adolescent patients (6 to 17 years old) with ADHD in Japan since March 2017. INTUNIV is being co-developed and commercialized by Shire and Shionogi under a licensing contract signed in 2011.

ADHD is characterized by 3 core symptoms of inattention, hyperactivity or impulsivity, or a combination of these symptoms,^3,4 and can have substantial impact on major areas of life, including: schooling, work and employment, behaviour, and social functioning.^5,6,7   Non-stimulant medications are an important alternative to stimulants for some patients with ADHD.

Click here to read the full press release.